Search

Copyright of Anaesthesiologie & Intensivmedizin is the property of DGAI e.V. - Deutsche Gesellschaft fur Anasthesiologie und Intensivmedizin e.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Type 2 diabetes mellitus (T2DM) is a major health problem in the western world. Despite a widespread implementation of integrated care programs there are still patients with poorly controlled T2DM. Shared goal setting within the process of Shared Decision Making (SDM) may increase patient's compliance and adherence to treatment regimen. In our secondary analysis of the cluster-randomized controlled DEBATE trial, we investigated if patients with shared vs. non-shared HbA1c treatment goal, achieve their glycemic goals. Methods: In a German primary care setting, we collected data before intervention at baseline, 6, 12 and 24 months. Patients with T2DM with an HbA1c ≥ 8.0% (64 mmol/mol) at the time of recruitment and complete data at baseline and after 24 months were eligible for the presented analyses. Using a generalized estimating equation analysis, we analysed the association between the achievement of HbA1c goals at 24 months based on their shared vs. non-shared status, age, sex, education, partner status, controlled for baseline HbA1c and insulin therapy. Results: From N = 833 recruited patients at baseline, n = 547 (65.7%) from 105 General Practitioners (GPs) were analysed. 53.4% patients were male, 33.1% without a partner, 64.4% had a low educational level, mean age was 64.6 (SD 10.6), 60.7% took insulin at baseline, mean baseline HbA1c was 9.1 (SD 1.0). For 287 patients (52.5%), the GPs reported to use HbA1c as a shared goal, for 260 patients (47.5%) as a non-shared goal. 235 patients (43.0%) reached the HbA1c goal after two years, 312 patients (57.0%) missed it. Multivariable analysis shows that shared vs. non-shared HbA1c goal setting, age, sex, and education are not associated with the achievement of the HbA1c goal. However, patients living without a partner show a higher risk of missing the goal (p =.003; OR 1.89; 95% CI 1.25–2.86). Conclusions: Shared goal setting with T2DM patients targeting on HbA1c-levels had no significant impact on goal achievement. It may be assumed, that shared goal setting on patient-related clinical outcomes within the process of SDM has not been fully captured yet. Trial registration: The trial was registered at ISRCTN registry under the reference ISRCTN70713571. [ABSTRACT FROM AUTHOR]

Hidradenitis suppurativa (HS) is a chronic skin disease that is often associated with metabolic disorders. Diabetes mellitus (DM) is a frequent comorbidity in HS. There is currently no established screening for DM in HS patients. The aim of our study was to identify high-risk groups of HS patients that develop DM and to assess the frequency of different types of DM present in HS patients. To do so, we conducted a monocentric study in 99 patients with HS. All patients underwent detailed clinical and laboratory assessments, including the determination of glycated hemoglobin. Among the 20.2% of patients that presented with DM, type 2 was by far the most prevalent (19 out of 20 patients). Moreover, male gender, age, BMI, Hurley stage, modified Hidradenitis Suppurativa Score (mHSS), DLQI and hypertension all correlated with the glycated hemoglobin levels in the HS patients. In the multivariable analysis, Hurley stage III, older age, and higher BMI were significantly associated with DM. Specifically, patients at Hurley stage III were at a 5.3-fold increased risk of having DM type II compared to patients at earlier Hurley stages. Since many of the HS patients had not been diagnosed, our study reveals shortcomings in the screening for DM and suggest that this should be routinely performed in HS patients at high risk to avoid secondary complications. [ABSTRACT FROM AUTHOR]

Background: Diabetes mellitus is a major global health burden associated with high morbidity and mortality. Although a short adult body height has been associated with increased risk of type 2 diabetes (T2D), there are large inconsistencies between the studies. Therefore, we aimed to investigate the association between body height and T2D in a large cohort of adult outpatients in Germany. Methods: A total of 783,029 adult outpatients with available body height data from the Disease Analyzer (IQVIA) database were included in Germany between 2010 and 2020. The incidence of diabetes mellitus (type 1 and type 2) was evaluated as a function of the patients' body height stratified by age, sex, and body-mass-index (BMI). Results: In both women and men in all age groups, incidence of T2D decreased with the increasing body height (<50, 51–60, 61–70, and >70 years). There was no association between the body height and the individual HbA1c value. In multivariable Cox regression analyses adjusted for patient age and BMI, hazard ratios for the development of T2D were 1.15 (95% CI: 1.13–1.17) for each 10 cm decrease in body height in women and 1.10 (95% CI: 1.09–1.12) in men. No significant association was found between body height and the development of T1D. Conclusions: We present the first data from a large cohort of outpatients in Germany, providing strong evidence for an association between adult body height and T2D. These data add to the current literature and might help in implementing body height into existing diabetes risk stratification tools to further reduce morbidity and mortality worldwide. [ABSTRACT FROM AUTHOR]

Aims: To characterize children and adolescents with latent autoimmune diabetes of the young (LADY), and to assess the utility of classifying individuals as LADYs regarding their cardiovascular (CV) risk factors. Methods: Data from 25,520 individuals (age at diagnosis <18 years) of the Prospective Diabetes Follow‐up Registry Diabetes‐Patienten Verlaufsdokumentation (DPV) were analyzed. LADY was defined as positivity of ≥one islet autoantibody (iAb+) and an insulin‐free interval of ≥6 months upon diabetes diagnosis. LADYs were compared to iAb+ individuals immediately requiring insulin ("immunologically confirmed" type 1 diabetes, T1DM), iAb−/Ins− individuals ("classical" T2DM) and to those clinically defined as T2DM (iAbs not measured). Results: Clinical characteristics of LADYs (n = 299) fell in between those with T1DM (n = 24,932) and T2DM (iAb−/Ins−, n = 152) or suspected T2DM (iAB not measured, n = 137). Stratifying LADYs according to their clinical diagnosis however revealed two distinct populations, highly resembling either T1DM or T2DM. Particularly, CV risk profile, precisely prevalence rates of arterial hypertension and dyslipidemia, was significantly higher in LADYs clinically classified as T2DM compared to LADYs classified as T1DM, and did not differ from those with "classical" T2DM. Conclusions: In terms of CV risk, classifying children and adolescents with diabetes as LADYs provides no additional benefit. Instead, clinical diagnosis seems to better assign individuals to appropriate risk groups for increased CV risk profiles. [ABSTRACT FROM AUTHOR]

The article presents the discussion on inaugural guideline on diabetes technology being published. Topics include created a means to utilize technology without requiring on body devices though studies in the pediatric population; and clinical trials and real‐world data demonstrated improvements in glycemia with use of automated insulin delivery (AID).

Objective: To describe clinical presentation/longterm outcomes of patients with ABCC8/KCNJ11 variants in a large cohort of patients with diabetes. Research Design and Methods: We analyzed patients in the Diabetes Prospective Follow‐up (DPV) registry with diabetes and pathogenic variants in the ABCC8/KCNJ11 genes. For patients with available data at three specific time‐points—classification as K+‐channel variant, 2‐year follow‐up and most recent visit—the longitudinal course was evaluated in addition to the cross‐sectional examination. Results: We identified 93 cases with ABCC8 (n = 54)/KCNJ11 (n = 39) variants, 63 of them with neonatal diabetes. For 22 patients, follow‐up data were available. Of these, 19 were treated with insulin at diagnosis, and the majority of patients was switched to sulfonylurea thereafter. However, insulin was still administered in six patients at the most recent visit. Patients were in good metabolic control with a median (IQR) A1c level of 6.0% (5.5–6.7), that is, 42.1 (36.6–49.7) mmol/mol after 2 years and 6.7% (6.0–8.0), that is, 49.7 (42.1–63.9) mmol/mol at the most recent visit. Five patients were temporarily without medication for a median (IQR) time of 4.0 (3.5–4.4) years, while two other patients continue to be off medication at the last follow‐up. Conclusions: ABCC8/KCNJ11 variants should be suspected in children diagnosed with diabetes below the age of 6 months, as a high percentage can be switched from insulin to oral antidiabetic drugs. Thirty patients with diabetes due to pathogenic variants of ABCC8 or KCNJ11 were diagnosed beyond the neonatal period. Patients maintain good metabolic control even after a diabetes duration of up to 11 years. [ABSTRACT FROM AUTHOR]

Background: This study investigated the diagnostic delay and the subsequent quality of care during the Covid‐19 pandemic among children with new‐onset type 1 diabetes. Methods: We compared the HbA1c levels of 3111 children at diagnosis of type 1 diabetes and of 2825 children at a median follow‐up of 4.7 months (interquartile range, 4.1–5.4) together with their daily insulin requirement during the Covid‐19 pandemic with the two previous years via multivariable linear regression, using data from the German Diabetes Registry DPV. Results: During the Covid‐19 pandemic, HbA1c levels were higher at diagnosis of type 1 diabetes (mean estimated difference, 0.33% [95% confidence interval, 0.23–0.43], p < 0.001), but not at follow‐up (mean estimated difference, 0.02% [−0.02–0.07]). Children with diabetes onset during the Covid‐19 pandemic had a significantly higher daily insulin requirement after initiation of therapy (mean estimated difference, 0.08 U/kg [0.06–0.10], p < 0.001). Both the increase in HbA1c and daily insulin requirement were evident only after the first wave of the pandemic. Conclusions: This increase in HbA1c at diagnosis of type 1 diabetes during the Covid‐19 pandemic may indicate a delay in seeking medical care due to the pandemic. However, this did not affect short‐term glycemic control. The increased insulin requirement at follow‐up could suggest a more rapid autoimmune progression during the pandemic. [ABSTRACT FROM AUTHOR]

Aim: To describe the different insulin therapy patterns and insulin daily doses in children and adolescents (aged 1‐17 years) with type 1 diabetes. Methods: This cross‐sectional study based on the longitudinal prescription (LRx) database (IQVIA) included children and adolescents who received at least two insulin prescriptions of the same drug from 1 January 2016 to 31 December 2019. The study outcomes included the proportion of patients with insulin pumps and multiple daily injection therapy, human insulin and insulin analogue use, as well as insulin daily doses. A multivariable linear regression model was used to study the association between age, sex, insulin drugs, and daily dose. Results: A total of 22 512 children and adolescents (mean age: 13.5 years, 47.1% female) were included. The proportion of patients using insulin pump therapy decreased with age, from 72.6% (females) and 73.0% (males) in the age group of younger than 6 years to 30.8% (females) and 26.1% (males) in adolescents. Insulin aspart was the most common short‐acting insulin, with the proportion of users increasing from 56% in the age group of younger than 6 years to 69%‐70% in the 13‐17 years age group. The daily dose of insulin pump therapy was 10 units lower than multiple daily injection (MDI) (P <.001). Conclusion: We found a marked age dependency for pump use, with a strong increase observed in the youngest age group. Insulin aspart was the most frequently used analogue insulin. A higher total daily insulin dose was shown in patients on MDI versus insulin pump, along with a significant age dependency. [ABSTRACT FROM AUTHOR]

Background: Although several studies have investigated factors associated with the onset and occurrence of hyperinsulinaemia-associated laminitis (HAL), few have examined the factors associated with the rate of improvement during recovery from an acute bout of the disease. This observational study sought to discover if a range of demographic, morphologic, hormonal and metabolic variables are associated with the improvement rate from HAL in 37 naturally-occurring cases identified by 16 clinics across Germany. Each case was evaluated for laminitis severity on the day of inclusion in the trial (d 0), then after 4, 9, 14, 25 and 42 d. The horses were managed according to best clinical practice including restricting exercise and prescribing a diet of hay-only, for a minimum of 9 d. Blood samples were also collected during each evaluation, except on d 9, and analysed for glucose, insulin, ACTH and leptin. Results: Based on individual clinical laminitis scores plotted against time, most horses improved markedly within 2 weeks, with a 'fast group' (n = 27) having a median (interquartile range) score on a 12-point scale of 0 (0–2) by d 14. However, there was a clear disparity within the total cohort, as ~ 1 in 4 horses demonstrated much slower improvement, with a median score of 5 (4–7) by d 14, or a marked relapse thereafter ('slow group', n = 10). Horses in the slow improvement group were younger (12.5 (8.8–16.3) vs 17 (14–24) yr; P = 0.008), but were not more likely to be heavier, male, very fat, to have presented with a previous history of laminitis or elevated ACTH concentrations, or to be receiving pergolide treatment. Of the hormonal and metabolic parameters measured, glucose and insulin concentrations were within the normal range following transition to the hay-only diet, but were higher in the group that failed to improve quickly, with a small but significant difference being evident on d 4, 14 and 25 for glucose (11 to 16%; P < 0.05), and a larger difference for insulin on d 14 and 25 (51 to 55%; P < 0.05). There was no difference between the groups in ACTH or leptin concentrations throughout the study. The main limitations of this study were the small number of slow-improvement horses and an inability to control or measure certain variables, such as feed quality. Conclusions: Young age and a modest increase in blood glucose and insulin concentrations are associated with delayed laminitis improvement. [ABSTRACT FROM AUTHOR]

Introduction: The study was designed to assess patient satisfaction, preferences and injection habits for patients using insulin lispro 200 units/ml pen (IL200) compared to their previously used disposable 100 units/ml mealtime insulin pen ("MTI-100 pen") in Germany. Methods: A site-based, cross-sectional study involving a self-reported survey and medical record extraction in patients with diabetes currently using IL200 for between 3 and 12 months and had previously used any disposable MTI-100 pen. Results: Of 114 patients included, 83.3% were satisfied with IL200 and 3.5% were dissatisfied; 70.2% preferred IL200 over their previous MTI-100 pen and 4.4% preferred their previous MTI-100 pen. The main reasons for IL200 preference were the amount of insulin the pen carries, longer use before discarding, number of non-empty pens discarded, injection volume and frequency replacing pens. Patients discarded (median) 4 IL200 pens per month with 5.3% discarding more than 10 units in their last pen. When insufficient insulin remained to complete a dose, 74.6% injected the remainder and completed with a new pen, 19.3% discarded the pen with remaining insulin, 7.0% saved it for future use and 1.8% left the dose incomplete. Conclusions: Satisfaction and preference for IL200 was high in this sample of patients using IL200 for 3–12 months. Reasons were consistent with IL200 features, explaining the better patient experience and potential resource saving transitioning from a disposable MTI-100 pen. [ABSTRACT FROM AUTHOR]

Aim: To explore parents' expectations of the perceived barriers to and benefits of 1 year of monthly video consultations combined with regular outpatient care of children with type 1 diabetes. Methods: The Virtual Diabetes Outpatient Clinic for Children and Youth (VIDIKI) study was a controlled, multicentre, perennial study with 240 participants from northern Germany. Fifty‐four qualitative interviews with parents were analysed using qualitative content analysis. Before the intervention, 30 interviews were conducted to assess parents' expectations, and after 1 year, 24 interviews evaluated the experienced benefits and barriers to video consultations. Results: Four main topics were identified from parents' responses to the video consultation. The main advantages of the video consultation compared with standard care were a higher frequency of contact for optimized insulin dosing and saving time; difficulties with internet connections were identified as the main barrier. A feeling of increased confidence with respect to insulin dosing was directly associated with telemedicine. Digital prescriptions and meeting the same diabetologist in both outpatient and telemedical care were mentioned as important improvements. The majority of interviewees preferred intervals of 4–6 weeks between video consultations. Conclusion: The higher frequency of contact with the diabetes team was considered a great relief by parents of children with type 1 diabetes. Apart from the time savings and flexibility in appointments, the most important advantages were the higher frequency of contact leading to short‐term therapy adjustments and an increase in the ability to adjust therapy independently. (German Clinical Trials Registry No: DRKS00012645). [ABSTRACT FROM AUTHOR]

Background and aim: Despite increasing knowledge, treatment options and funding, the number of type-2 diabetes mellitus (T2DM) patients who achieve their glycemic targets has not increased in the past 2 decades. Medical guidelines aim for favorable outcomes, but adherence to T2DM guidelines is low. Our analysis evaluates T2DM guideline adherence for Germany, its associations with glycemic target achievement and physicians' perspectives on adherence. Methods: In this observational study, 108 T2DM patients in diabetology specialist care, receiving initial or adjusted insulin therapy, were included in the analysis. Guideline adherence was assessed for four areas of the German national treatment guideline (NVL): (1) completing 12 disease monitoring tasks, (2) screening for 5 diabetes comorbidities and complications, (3) treatment targets in 5 dimensions and (4) adherence to the therapy algorithm along the patient pathway. Glycemic target achievement was assumed when the last HbA1c measurement was ≤ the individual HbA1c target. Physicians' opinion on guideline adherence (importance for treatment success, ease of implementation) was gathered through a survey. Results: Adherence rates to the four NVL areas were 44%–92%. Forty-three percent of participants achieved their HbA1c target. Participants treated adherent to 2+ or 3+ NVL areas had higher rates of target achievement than the counter groups (chi2 = 3.280/2.738, p = 0.070/0.098). There was strong consensus between physicians about the relevance of each NVL area. Conclusion: Patients with T2DM benefit from comprehensive guideline-adherent treatment. A study with larger sample size is required to confirm results. Digital tools can facilitate embedding of guideline information into daily clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: The IGLU-SIT study documented the effectiveness of initiating supplementary prandial insulin treatment (SIT) with insulin glulisine after failure of oral antidiabetic drugs alone in patients with type 2 diabetes (T2DM) in a real-world setting in Germany. Methods: The IGLU-SIT study was an open-label, prospective, multicentre, non-interventional study with an observation period of 12 ± 1 months. The primary objective was to determine the proportion of patients reaching their pre-defined glycosylated haemoglobin (HbA1c) goal at 3, 6, 9 and 12 months. Selected secondary objectives were absolute change in HbA1c, a 7-point blood glucose profile, and rate of hypoglycaemia. Data were evaluated overall and by age group (< 65, 65–74 and ≥ 75 years). Results: Overall, 215 patients with T2DM were observed in 64 centres. Baseline HbA1c was 8.3%, and mean HbA1c target was 6.8% (baseline 8.1% and target 6.9% in patients ≥ 75 years). Individual HbA1c target attainment in patients peaked at 38.9% (95% confidence interval [CI] 32.1–46.1%) after 12 months; this was 45.9% in patients aged ≥ 75 years. The mean HbA1c reduction was 1.12 ± 1.05% (p < 0.0001) with only minor differences by age group. A 7-point blood glucose profile revealed significant reductions (p < 0.0001) at all time-points. The rate of confirmed symptomatic hypoglycaemia was 2.2% (95% CI 0.7–5.1) during the 12-month follow-up; rates were increased in patients aged ≥ 75 years (7.0%; 95% CI 1.5–19.1) as were the rates of adverse events (17.8 vs. 6.1%). Conclusion: Initiating SIT with insulin glulisine is an appropriate treatment option in patients whose T2DM is insufficiently controlled. Particular attention should be paid to elderly patients in whom higher attainment rates of treatment target were associated with adverse events. Trial Registration: https://awbdb.bfarm.de; Identifier: 6819; Date of registration: 23.06.2016 [ABSTRACT FROM AUTHOR]

Introduction: The IGLU-S study assessed the effectiveness of insulin glulisine after switching from human insulin/other rapid-acting insulin analogues in patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) in a real-world setting in Germany. Methods: Open-label, prospective, multicentre, non-interventional study in Germany. The primary outcome was proportion of patients reaching pre-defined glycosylated haemoglobin A1c (HbA1c) goal at 3, 6, 9 and 12 months. Secondary outcomes included absolute changes in HbA1c, rate of hypoglycaemia and 7-point blood glucose profiles. Results: Overall, 432 (55 T1DM, 377 T2DM) patients were enrolled. Baseline HbA1c was 8.2% (T1DM) and 8.3% (T2DM); individual HbA1c targets were 6.8% and 6.9%, respectively. After insulin glulisine introduction, the proportion of patients achieving their individual HbA1c increased to 43.6% (T1DM) and 39.6% (T2DM) of patients at 12 months. At 12 months, mean HbA1c was reduced by 0.86 ± 1.03% (p < 0.0001) in T1DM and 1.01 ± 1.02 (p < 0.0001) in T2DM. The 7-point blood glucose profile showed a significant reduction in patients with T2DM (p< 0.0001) and a non-significant reduction in T1DM patients. Confirmed symptomatic hypoglycaemia was 5.7% (T1DM) and 1.6% (T2DM). There were no cases of severe hypoglycaemia. Conclusion: Switching prandial insulin to insulin glulisine resulted in improved effectiveness with 43.6% of T1DM and 39.6% of T2DM patients reaching their individual pre-defined HbA1c target within 1 year. Switching was safe and was associated with a low rate of hypoglycaemia and adverse events. Trial Registration: https://awbdb.bfarm.de; Identifier: 6818; Date of registration: 23.06.2016 [ABSTRACT FROM AUTHOR]

Aims: Comprehensive knowledge, specific skills and data‐analysis competences are prerequisites for the successful use of continuous glucose monitoring (CGM) systems. SPECTRUM is a structured training programme for real‐time CGM (rtCGM) consisting of a web‐based introduction and six group sessions of 90 min each. The 'CGM‐TRAIN study' evaluated the efficacy and acceptance of SPECTRUM and rtCGM systems among adults with insulin therapy. Methods: Participants (n = 120) were recruited from 10 German diabetes centres in which they were treated under usual care conditions. Outcome measures were rtCGM knowledge, practical skills, satisfaction with the training programme, satisfaction and acceptance of rtCGM system and glycaemic control. Data were collected at study entry, after training completion and at 6‐month follow‐up. Results: All participants were diagnosed with type 1 diabetes (56% women, mean age 42.4 ± 13.4 years, diabetes duration 21.6 ± 11.6 years), 110 participants completed the course. After training completion, rtCGM‐specific knowledge had improved by 43% (scale: 0–40 points) from 21.2 ± 7.6 to 30.4 ± 4.5 points; p < 0.001. The knowledge‐level persisted until follow‐up (29.4 ± 4.5). Participants were able to master nearly all the practical requirements of the technology. In addition, rtCGM was highly accepted, and participants were motivated to use their systems continuously. HbA1c improved slightly from 61 ± 14 mmol/mol (7.7 ± 1.3%) before training to 60 ± 14 mmol/mol (7.6 ± 1.3%) at follow‐up (p = 0.04). The training programme itself was favourably rated by participants. Conclusions: Under usual out‐patient daily care conditions, the training programme SPECTRUM improved knowledge and skills about rtCGM in adults with type 1 diabetes. This was associated with a reduced HbA1c, high satisfaction and acceptance of rtCGM (Clinical Trials Registry no.: DRKS00014380). [ABSTRACT FROM AUTHOR]

Background: Endocrinopathic, or hyperinsulinaemia-associated laminitis (HAL) is a common and debilitating equine foot disease, and although no pharmacological treatments are registered, several are under development. To evaluate the effect of such treatments, an accurate and consistent method is needed to track the clinical signs of laminitis over time, and the natural history of the disease, in terms of a 'normal' pattern of improvement, needs to be understood. This study examined the improvement pattern in clinical cases of naturally-occurring HAL subjected to a range of best-practice interventions, using two different scoring methods. Eighty horses and ponies with suspected HAL were enrolled in a study conducted at 16 veterinary practices across Germany. The severity of laminitis was assessed by independent veterinarians using both the traditional Obel method and a modified Obel method developed by Meier and colleagues. Assessments were made on the day of diagnosis (d 0), then on days 4, 9, 14, 25 and 42 during the intervention period. Pain medications were withheld for 24 h prior to clinical examination in all cases. Results: Time to marked improvement from laminitis varied between individuals, but was difficult to monitor accurately using the Obel method, with the median grade being 2/4 on days 0 and 4, then 0/4 from d 9 onwards. More subtle changes could be identified using the Meier method, however, and the median scores were seen to follow the form of an exponential decay model in most horses, improving from 8/12 on d 0, to 0/12 on d 25. Within this composite scoring method, considerable variation was observed in the rate of improvement of individual clinical signs, with the average time taken for each sign to reach a median score of 0 ranging from 4 days (foot lift and weight shifting) to 25 days (gait when turned in a circle) across all 80 horses. Conclusions: The Meier method provides a reliable and consistent method for monitoring the clinical status of horses with HAL, and despite the variability, the pattern of improvement described here should provide a useful benchmark against which individual cases and new treatments can be assessed. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes represents an increasingly critical challenge for health policy worldwide. It absorbs massive resources from both patients and national economies to sustain direct costs of the treatment of type 2 diabetes and its complications and indirect costs related to work loss and wages. More recently, there are innovations based on remote control and personalised programs that promise a more cost-effective diabetes management while reducing diabetes-related complications. In such a context, this work attempts to update cost analysis reviews on type 2 diabetes, focusing on France and Germany, in order to explore most significant cost drivers and cost-saving opportunities through innovations in diabetes care. Although both countries approach care delivery differently, France and Germany represent the primary European markets for diabetes technologies.Methods: A systematic review of the literature listed in MEDLINE, Embase and EconLit has been carried out. It covered interventional, observational and modelling studies on expenditures for type 2 diabetes management in France or Germany published since 2012. Included articles were analysed for annual direct, associated and indirect costs of type 2 diabetes patients. An appraisal of study quality was performed. Results were summarised narratively.Results: From 1260 records, the final sample was composed of 24 papers selected according to predefined inclusion/exclusion criteria. Both France and Germany revealed a predominant focus on direct costs. Comparability was limited due to different study populations and cost categories used. Indirect costs were only available in Germany. According to prior literature, reported cost drivers are hospitalisation, prescriptions, higher HbA1c and BMI, treatment with insulin and complications, all indicators of disease severity. The diversity of available data and included costs limits the results and may explain the differences found.Conclusions: Complication prevention and glycaemic control are widely recognized as the most effective ways to control diabetes treatment costs. The value propositions of self-based supports, such as hybrid closed-loop metabolic systems, already implemented in type 1 diabetes management, are the key points for further debates and policymaking, which should involve the perspectives of caregivers, patients and payers. [ABSTRACT FROM AUTHOR]

To understand physicians' reasons for prescribing Insulin Lispro 200 units/ml (IL200) and their experience with IL200 treatment in Germany. The survey consisted of 28 questions on physician's profile, average IL200 patients' characteristics and rationales for prescribing IL200. Questions were rated on a scale of 0 ('not at all important'/'strongly disagree') to 4 ('absolutely important'/'strongly agree'). The surveyed physicians had a mean (SD) experience of 18.1 (7.0) years managing diabetes, consulted an average of 226.8 patients with diabetes/month and prescribed IL200 to 56.1% of their patients on mealtime insulin (MTI). About 80.0% of IL200 patients had type 2 diabetes mellitus, were overweight/obese, and received >20 units/day of MTI. More than 70.0% of physicians rated patient's insulin dose, pattern of self-measured glucose levels, hemoglobin A1c (HbA1c) (clinical); adherence, hypoglycemia knowledge, motivation to improve lifestyle, desire to reduce injection volume and emotional struggle with controlling HbA1c (behavioral) as 'very important'/'absolutely important' factors when prescribing IL200. Physicians considered IL200 a promising treatment option that reduces the injection burden for patients on MTI. Physicians adopted a patient-centered perspective by aligning IL200 prescribing decisions with each patient's medical needs and non-clinical preferences, with an aim to encourage treatment adherence through resorting to IL200's advantageous attributes. [ABSTRACT FROM AUTHOR]

Insulin lispro 200 U/mL (IL200) is a treatment choice for people with diabetes who have daily mealtime insulin (MTI) requirements of >20 U/day. We report clinical characteristics of real world IL200 users in Germany to understand clinical settings and the type of patients who would benefit from IL200 treatment. This retrospective database analysis used the patient-level data from "IMS Disease Analyzer" in Germany from February 2015 to June 2016. Clinical and demographic information were collected and analyzed for IL200 users alongside that of those who were using more than 20 U a day of 100 U/mL analog MTI. Of the 17,261 patients using insulin, 811 were identified in IL200 group. The IL200 group had 60% men, mean ± SD age of 63.6 ± 11.9 years, and BMI of 36.2 ± 6.7 kg/m2. Of these, 63.5% (n = 515) were seen by diabetologists, while 36.5% (n = 296) were seen by general practitioners (GPs). In the IL200 group, 77.7% used basal insulin concomitantly, >90% had ≥1 comorbidity, and 52% had ≥4 comorbidities; the most common being hypertension (75.2%), neuropathy (66.0%), and nephropathy (59.6%). Diabetologist-treated IL200 users were more likely to have multiple comorbidities as compared with those treated by GPs (15.0% vs. 12.9% for >5 comorbidities). IL200 is prescribed to people with diabetes who need more than 20 U/day of mealtime insulin and tend to be more obese, older, and with multiple comorbidities. Future research should explore how concentrated MTI can impact adherence and long-term glycemia. [ABSTRACT FROM AUTHOR]

Introduction: Liraglutide is a glucagon-like peptide-1 analogue used to treat type 2 diabetes mellitus (T2DM). To date, limited long-term data (> 2 years) exist comparing real-world diabetes-related effectiveness and costs for liraglutide versus insulin treatment. Methods: This retrospective claims data analysis covered the period from 1 January 2010 to 31 December 2017 and included continuously insured patients with T2DM who initiated insulin or liraglutide and had 3.5 or 5 years' follow-up data, identified using the German AOK PLUS dataset. Propensity score matching (PSM) was used to adjust for patient characteristics. Results: After PSM, there were 825 and 436 patients in the liraglutide and insulin groups at 3.5 and 5 years' follow-up, respectively. Baseline characteristics were similar between compared cohorts. The respective change from baseline to follow-up in mean glycated haemoglobin for liraglutide and insulin patients was − 0.88% and − 0.81% (p > 0.100) after 3.5 years and − 1.15%/ − 1.02% (p > 0.100) after 5 years. Mean respective changes in body mass index (kg/m2) were − 1.21/+ 1.14 (p < 0.001) after 3.5 years and − 1.29/+ 1.13 after 5 years (p < 0.001). Liraglutide- versus insulin-treated patients were less likely to have an early T2DM-related hospitalisation (3.5-year hazard ratio [HR]: 0.414 [95% confidence interval (CI) 0.263–0.651]; 5-year HR: 0.448 [95% CI 0.286–0.701]). At 5 years' follow-up, there was no statistically significant difference in total direct costs between treatment groups (cost ratio: 1.069 [95% CI 0.98–1.13]; p > 0.100). Conclusion: The clinical effectiveness of liraglutide is maintained long term (up to 5 years). Liraglutide treatment is not associated with higher total direct healthcare costs. [ABSTRACT FROM AUTHOR]

Objective: The rs738409(G) single nucleotide polymorphism (SNP) in the patatin-like phospholipase domain-containing 3 (PNPLA3) gene associates with increased risk and progression of nonalcoholic fatty liver disease (NAFLD). As the recently described severe insulin-resistant diabetes (SIRD) cluster specifically relates to NAFLD, this study examined whether this SNP differently associates with hepatic lipid content (hepatocellular lipids [HCL]) and insulin sensitivity in recent-onset diabetes.Research Design and Methods: A total of 917 participants in the German Diabetes Study (GDS) underwent genotyping, hyperinsulinemic-euglycemic clamps with stable isotopic tracer dilution, and MRS.Results: The G allele associated positively with HCL (β = 0.36, P < 0.01), independent of age, sex, and BMI across the whole cohort, but not in the individual clusters. Those with SIRD exhibited lowest whole-body insulin sensitivity compared with those with severe insulin-deficient (SIDD), moderate obesity-related (MOD), moderate age-related (MARD), and severe autoimmune diabetes (SAID) clusters (all P < 0.001). Interestingly, the SIRD group presented with higher prevalence of the rs738409(G) SNP compared with other clusters and the glucose-tolerant control group (P < 0.05). HCL was higher in the SIRD group (median 13.6% [1st quartile 5.8; 3rd quartile 19.1] compared with the MOD (6.4 % [2.1; 12.4], P < 0.05), MARD (3.0% [1.0; 7.9], P < 0.001), SAID (0.4% [0.0; 1.5], P < 0.001), and glucose-tolerant (0.9% [0.4; 4.9), P < 0.001) group. Although the PNPLA3 polymorphism did not directly associate with whole-body insulin sensitivity in SIRD, the G-allele carriers had higher circulating free fatty acid concentrations and greater adipose tissue insulin resistance compared with noncarriers (both P < 0.001).Conclusions: Members of the SIRD cluster are more frequently carriers of the rs738409(G) variant. The SNP-associated adipose tissue insulin resistance and excessive lipolysis may contribute to their NAFLD. [ABSTRACT FROM AUTHOR]

Aim: To investigate the incidence of severe hypoglycaemia over the past 10 years, taking into account changes in anti‐hyperglycaemic therapy. Methods: This retrospective population‐based study used German health insurance data. All adults diagnosed with documented type 2 diabetes (extrapolated to the German population: 6.6 million in 2006; 7.9 million in 2011; 8.86 million in 2016) were screened for severe hypoglycaemia. Anti‐hyperglycaemic agents were identified by Anatomical Therapeutic Chemical (ATC) code. Results: The event rate for severe hypoglycaemia was 460 per 100 000 people in 2006, 490 per 100 000 in 2011 and 360 per 100 000 in 2016. The proportion of people with severe hypoglycaemia receiving sulfonylureas, as well as receiving combination therapy of metformin and sulfonylureas decreased from 2006 to 2016 (23.6% vs. 6.2%) Among those with severe hypoglycaemia in 2006, there were no prescriptions for dipeptidyl peptidase‐4 (DPP‐4) inhibitors, glucagon‐like peptide‐1 (GLP‐1) receptor agonists or sodium–glucose co‐transporter 2 (SGLT2) agonists. The proportions of people with severe hypoglycaemia receiving DPP‐4 inhibitors, GLP‐1 receptor agonists or SGLT2 agonists in 2011 and 2016 were low. The proportion of people receiving human insulin also decreased (from 11.3% in 2006 to 10.3% in 2011 and 4.3% in 2016); the proportion of people receiving insulin analogues increased from 5.4% in 2006 to 11.5% in 2016. Therapy with mixed insulins was used by 19.7% of people with severe hypoglycaemia in 2006, by 14.0% in 2011 and by 7.3% in 2016. People undergoing therapy with insulin analogues have the highest risk of severe hypoglycaemia adjusted by age, gender, nephropathy diagnosis and year of survey [odds ratio (OR) 14.4, 95% confidence interval (95% CI) 13.5–15.5]. Conclusion: The incidence of severe hypoglycaemic events in Germany increased between 2006 and 2011, and decreased in 2016. What's new?: We were able to follow up the incidence of severe hypoglycaemia in a large cohort of people with type 2 diabetes over a period of 10 years.The incidence of severe hypoglycaemia increased from 2006 to 2011 and decreased from 2011 to 2016.The highest risk of severe hypoglycaemia is associated with treatment with insulin analogues, after adjustment for age, sex, nephropathy diagnosis and year. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness and safety of initiating basal insulin‐supported oral therapy (BOT) with insulin glargine 300 U/mL (Gla‐300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs). Materials and Methods: This non‐interventional, multi‐centre, prospective 52‐week study, conducted in Germany and Switzerland, documented patients with type 2 diabetes with an HbA1c of between 7.5% and 10.0%, currently treated with OADs, after the physician had decided to start a BOT regimen with Gla‐300. The primary endpoint was the rate of achievement of the individualized predefined HbA1c target. Results: Of 1748 patients included, 1153 comprised the full analysis set, of whom 721 completed documentation of 12 months of Gla‐300 treatment. Twelve months after starting Gla‐300, 49.9% achieved their individualized HbA1c target, and 61.1% achieved either their HbA1c target or a fasting plasma glucose (FPG) of ≤110 mg/dL. Mean HbA1c decreased by −1.22% ± 1.05% to 7.28% ± 0.92% and mean FPG by −51.5 (±48.63) mg/dl to 132.9 ± 33.0 mg/dL. Median duration of HbA1c target achievement was 341 days and probability to remain on target after 6 months was 81%. Hypoglycaemia incidence and rates remained low after 12 months of Gla‐300 treatment; no severe or severe nocturnal hypoglycaemia was observed. Body weight remained unchanged. Conclusions: Starting a BOT regimen with Gla‐300 allowed about 60% of 721 German and Swiss patients with inadequately controlled type 2 diabetes to achieve glycaemic control within 12 months in daily clinical practice. Glycaemic control was achieved without weight gain or increased risk of nocturnal or severe hypoglycaemia. [ABSTRACT FROM AUTHOR]

Aim: To compare HbA1c levels across the lifespan in people with type 1 diabetes in the USA with those in Germany/Austria, and to examine potential differences in HbA1c levels between sexes, insulin delivery methods and minority status. Methods: Data were extracted from the US T1D Exchange Registry (n=18 381 participants from 73 sites) and from the German/Austrian Prospective Diabetes Follow‐up Registry, the DPV (n=32 643 participants from 362 sites). Mean HbA1c was calculated for each year of age for individuals aged ≤25 years, and at 2‐year age intervals for individuals aged >25 years. Curves for mean HbA1c by age were estimated using locally weighted scatterplot smoothing. HbA1c differences between registries, sexes, insulin delivery methods, and minority status were assessed by age group using multiple linear regression. Results: In both registries, mean HbA1c increased by ~11 mmol/mol (1.0%) between the ages of 9 and 18 years, although at quite different absolute levels: from 66 mmol/mol (8.2%) to 77 mmol/mol (9.2%) in the T1D Exchange Registry, and from 56 mmol/mol (7.3%) to 66 mmol/mol (8.2%) in the DPV. Sex differences were observed in the DPV only. In the T1D Exchange Registry, injection users had higher mean HbA1c than pump users across the lifespan, whereas in the DPV higher HbA1c levels in injection users were observed in the age groups 6 to <12 years, 12 to <18 years, and 30 to <50 years (P < 0.001). Minority status was significantly associated with higher HbA1c in most age groups in both registries. Conclusions: Significant differences in HbA1c were noted between the USA and Germany/Austria, with disparities more pronounced in early childhood through to young adulthood. Further studies should identify causes for these disparities. What's new?: Data from the TID Exchange Registry (T1DX) have shown that only few individuals with type 1 diabetes meet HbA1c targets, and that glycaemic control has worsened in adolescents over recent years.Although a similar increase in HbA1c on reaching adolescence was observed, young people in the German/Austrian DPV registry had HbA1c levels that were ˜11 mmol/mol (1.0%) lower compared with young people included in the T1DX.Comparison of the two contemporary diabetes cohorts showed large discrepancies in glycaemic control between developed Western countries, and highlights the need for increased efforts to improve care and particularly to lower HbA1c in young people with type 1 diabetes, especially those included in the T1DX. [ABSTRACT FROM AUTHOR]

Aim: To determine factors influencing the success of treatment for type 1 diabetes, defined as HbA1c < 58 mmol/mol (<7.5%), in a large paediatric cohort under real‐life conditions. Methods: This is a monocentric observational study analysing the determinants of glycaemic outcome (sex, age, comorbidities, sociodemographic factors, diabetes technology) in an entire cohort of people with diabetes aged up to 21 years. Glycaemic outcome was defined as an individual's median HbA1c and the prevalence of acute complications over this period. Results: Of 700 young people with type 1 diabetes [age 13.6 years (range: 1.4–20.9 years); diabetes duration 5.8 years (range: 0.1–18.3 years)], 63% were using an insulin pump and 32% any type of continuous glucose monitoring. Mean HbA1c was 61 mmol/mol [95% confidence interval (CI) 60–62; 7.7%, 95% CI 7.5–7.8]. Some 63% of children aged < 12 years reached HbA1c (58 mmol/mol (<7.5%) compared with 43% of older participants. The prevalence of severe hypoglycaemia was 2.41 events and that of diabetic ketoacidosis 1.4 events per 100 person‐years. Neither type of insulin therapy nor use of continuous glucose monitoring, sex or comorbidity with coeliac disease or thyroiditis was significantly associated with glycaemic outcome. However, age, diabetes duration, having a father not born in Germany, psychiatric comorbidities and family structure were associated with HbA1c. Conclusions: Current technologies and a multidisciplinary team approach allow high numbers of children and adolescents to realize tight glycaemic control with a low prevalence of acute complications. However, age‐related challenges, sociodemographic factors and psychological comorbidities are barriers to achieving best possible glycaemic outcome. What's new?: Several non‐medical factors such as overburdened parents and adolescents, cultural and sociodemographic characteristics, and psychosocial risks influence self‐management behaviour and thus treatment success in paediatric diabetes.Use of modern technology alone is not sufficient to optimize glycaemic outcomes.The implementation and use of technology needs to be discussed critically and tailored to the family's situation and coping capacity.Even with new technologies, diabetes management plans need to be individualized and focused on the family's strengths, barriers and psychosocial limitations. [ABSTRACT FROM AUTHOR]

Purpose To assess quality of life, glycemic control, and safety/tolerability associated with liraglutide versus insulin initiation in patients with type 2 diabetes in Germany. Methods Liraglutide/insulin-naïve adults with type 2 diabetes and inadequate glycemic control despite using oral antidiabetic medication were assigned to liraglutide (≤1.8 mg daily; n=878) or any insulin (n=382) according to the treating physician's decision and followed for 52 weeks. The primary objective was to evaluate Audit of Diabetes-Dependent Quality of Life (ADDQoL) scores. Results At baseline, the liraglutide group was younger and had shorter type 2 diabetes duration, lower glycated hemoglobin (HbA1c), higher body mass index, and a lower prevalence of certain diabetes-related complications than the insulin group (all p<0.05). ADDQoL average weighted impact scores improved numerically in both groups from baseline to 52 weeks (mean difference [95% confidence interval], liraglutide vs. insulin: 0.159 [−0.023;0.340]; not significant). Changes in general wellbeing and five ADDQoL domains significantly favored liraglutide (remaining 14 domains, not significant). HbA1c reductions were greater with insulin than liraglutide (−2.0% vs. −1.2%; p<0.01); however, mean HbA1c after 52 weeks was 7.2% in both groups. Compared with insulin, liraglutide significantly decreased body mass index (−1.54 kg/m2 vs. +0.27 kg/m2 ; p<0.001), systolic blood pressure (−5.03 mmHg vs. −1.03 mmHg; p<0.01) and non-severe hypoglycemia (0.85% vs. 4.55% at 52 weeks; p<0.01). Adverse drug reactions were reported for<3% of patients in both groups. Conclusions Liraglutide improved certain ADDQoL components and reduced body mass index, systolic blood pressure, and non-severe hypoglycemia versus insulin. Both treatments improved glycemic control. [ABSTRACT FROM AUTHOR]

In the treatment of children/adolescents with diabetes medical rehabilitation plays an important role. It was the aim of the survey to analyze trends in the number of patients admitted to rehabilitation, the quality of diabetes care, the incidence of acute complications, risk factors for cardiovascular co-morbidities like lipids and blood pressure and the familial status nationwide and over a period of 13 years. Methods: Currently seven hospitals offer in-patient rehabilitation for children/adolescents with diabetes in Germany. Six hospitals participated in the survey. All children/adolescents (n=7.163) who participated in an in-patient rehabilitation 01/01/2004-31/12/2016 were included. Clinical/familial data were assessed: age, sex, family situation, type/duration of diabetes, insulin dosage, self-monitoring, acute complications, height, body weight, blood pressure and laboratory parameters. For collecting and storage of data the computer software DPV® (Diabetes-Patienten-Verlaufsdokumentation, University of Ulm, Germany) was used. Statistical analyses were performed using the programme SAS (Statistical Analysis Software 9.4, SAS Institute Inc, Cary, North Carolina, USA). Results: During the study period 7.163 patients took part in 10.987 in-patient rehabilitation procedures. The yearly number of patients participating in rehabilitation remained stable. There was no change in the quality of diabetes control (HbA1c: p=0.30, fasting blood glucose: p=0.80). The incidence of severe hypoglycaemia decreased (p<0.001). The incidence of ketacidosis remained stable (p=0.18). The frequency of blood glucose self-monitoring increased (p<0.001). The same was true for patients treated with CSII (p<0.001), whereas the numbers of patients treated with CT or ICT decreased (both p<0.001). There was no change in patients' total insulin dose (p=0.01). There was a decrease of the number of patients living with both parents (p<0.001), the percentage of children/adolescents living with mother or father alone increased (p<0.001). The percentage of children/adolescents living in mixed cultural families or having a background of immigration increased (p<0.001). Conclusions: There is a change in medical rehabilitation: The number is stable, the proportion of patients using CSII increased, the number of patients living with single parents and the percentage of patients from culturally mixed families increased also. [ABSTRACT FROM AUTHOR]

Introduction: The impact of flash glucose monitoring technology on HbA1c in type 2 diabetes managed by basal bolus insulin is uncertain. Three parallel European retrospective non-interventional chart review studies collected data reported in medical records. Each country's study aim was to determine the effectiveness of the device on HbA1c when used by their population for 3–6 months as their standard of care for management of glycaemia in a real-world setting. Methods: Medical records were eligible for adult patients with type 2 diabetes, on a basal bolus insulin regimen for 1 year or more, device use for 3 months or more before the start of the study, an HbA1c concentration up to 3 months prior to starting device use (patients were using blood glucose monitoring for self-management) between 64 and 108 mmol/mol (8.0–12.0%) plus an HbA1c determination 3–6 months after commencing flash glucose monitoring use. Results: Records were analysed from 18 medical centres in Austria (n = 92), France (n = 88) and Germany (n = 183). Baseline HbA1c results, recorded up to 90 days before the start of device use, were comparable across the three countries and were reduced significantly by 9.6 ± 8.8 mmol/mol mean ± SD (Austria [0.9 ± 0.8%], p < 0.0001), 8.9 ± 12.5 mmol/mol (France [0.8% ± 1.1], p < 0.0001) and 10.1 ± 12.2 mmol/mol (Germany [0.9% ± 1.1], p < 0.0001). No significant differences were detected between age group, sex, BMI or duration of insulin use. Conclusions: Three European real-world, chart review studies in people with type 2 diabetes managed using basal bolus insulin therapy each concluded that HbA1c was significantly reduced after changing to use of flash glucose monitoring for 3–6 months in a real-world setting. [ABSTRACT FROM AUTHOR]

Aims: Time needed for health‐related activities in people with diabetes is assumed to be substantial, yet available data are limited. Time spent on self‐management and associated factors was analysed using cross‐sectional data from people with diagnosed diabetes enrolled in a population‐based study. Methods: Mean total time spent on self‐management activities was estimated using a questionnaire for all participants with diagnosed diabetes in the KORA FF4 study (n = 227, 57% men, mean age 69.7, sd 9.9 years). Multiple two‐part regression models were fitted to evaluate associated factors. Multiple imputation was performed to adjust for bias due to missing values. Results: Some 86% of participants reported spending time on self‐management activities during the past week. Over the entire sample, a mean of 149 (sd 241) min/week were spent on self‐management‐activities. People with insulin or oral anti‐hyperglycaemic drug treatment, better diabetes education, HbA1c 48 to < 58 mmol/mol (6.5% to < 7.5%) or lower quality of life, spent more time on self‐management activities. For example, people without anti‐hyperglycaemic medication invested 66 min/week in self‐management, whereas those taking insulin and oral anti‐hyperglycaemic drugs invested 269 min/week (adjusted ratio 4.34, 95% confidence interval 1.85–10.18). Conclusions: Time spent on self‐management activities by people with diabetes was substantial and varied with an individual's characteristics. Because of the small sample size and missing values, the results should be interpreted in an explorative manner. Nevertheless, time needed for self‐management activities should be routinely considered because it may affect diabetes self‐care and quality of life. What's new?: Few studies have analysed time spent on self‐management activities in diabetes. Factors associated with patterns of health‐related activities remain under‐researched.This population‐based study analysed a comprehensive set of self‐management activities in people with diabetes. In our entire sample, an average of 2.5 h/week were spent on self‐management activities. Time investments differed according to diabetes treatment, diabetes education, HbA1c and quality of life.Time needed for self‐management activities should be routinely considered because it may affect diabetes self‐care and quality of life. [ABSTRACT FROM AUTHOR]

Objective: We investigated the association between maternal use of vitamin D and omega‐3 fatty acids (n‐3 FAs) supplements during pregnancy and risk of islet autoimmunity (IA) in the offspring. Methods: The Environmental Determinants of Diabetes in the Young (TEDDY) Study is prospectively following 8676 children with increased genetic risk for type 1 diabetes in Finland, Germany, Sweden, and the United States. Blood samples were collected every 3 months between 3 and 48 months of age then every 6 months thereafter to determine persistent IA. Duration, frequency, and supplement dose during pregnancy were recalled by mothers at 3 to 4 months postpartum. Cumulative intakes of supplemental vitamin D and n‐3 FAs were analyzed as continuous or binary variables. We applied time‐to‐event analysis to study the association between maternal supplement use and IA, adjusting for country, human leukocyte antigen‐DR‐DQ genotype, family history of type 1 diabetes and sex. Secondary outcomes included insulin autoantibodies (IAA) or glutamic acid decarboxylase (GADA) as the first appearing autoantibody. Results: As of February 2018, there were 747 (9.0%) children with IA. Vitamin D supplement intake during pregnancy (any vs none) was not associated with risk for IA (hazard ratio [HR] 1.11; 95% confidence interval [CI] 0.94, 1.31); neither was cumulative vitamin D supplement intake. Supplemental n‐3 FA intake was similarly not associated with IA risk (HR: 1.19, 95% CI 0.98, 1.45). Similar lack of association was observed for either IAA or GADA as the first appearing autoantibody. Conclusions: The TEDDY cohort showed no evidence of benefit regarding IA risk for vitamin D or n‐3 FA supplementation during pregnancy. [ABSTRACT FROM AUTHOR]

Introduction: Diabetes technology improves glycemic control and quality of life for many people with type 1 diabetes (T1D). However, inequalities in access to diabetes technology exist in many countries. In Germany, disparities in technology use have been described in pediatric T1D, but no data for adults are available so far. We therefore aimed to analyze whether demographic factors and area deprivation are associated with technology use in a representative population of adults with T1D., Materials and Methods: In adults with T1D from the German prospective diabetes follow-up registry (DPV), we analyzed the use of continuous subcutaneous insulin infusion (CSII), continuous glucose monitoring (CGM), and sensor augmented pump therapy (SAP, with and without automated insulin delivery) in 2019-2021 by age group, gender, migration background, and area deprivation using multiple adjusted regression models. Area deprivation, defined as a relative lack of area-based resources, was measured by quintiles of the German index of Multiple Deprivation (GIMD 2015, from Q1, least deprived, to Q5, most deprived districts)., Results: Among 13,351 adults with T1D, the use of technology decreased significantly with older age: CSII use fell from 56.1% in the 18-<25-year age group to 3.1% in the ≥80-year age group, CGM use from 75.3% to 28.2%, and SAP use from 45.1% to 1.5% (all p for trend <0.001). The use of technology was also significantly higher in women than in men (CSII: 39.2% vs. 27.6%; CGM: 61.9% vs. 58.0%; SAP: 28.7% vs. 19.6%, all p <0.001), and in individuals without migration background than in those with migration background (CSII: 38.8% vs. 27.6%; CGM: 71.1% vs. 61.4%; SAP: 30.5% vs. 21.3%, all p <0.001). Associations with area deprivation were not linear: the use of each technology decreased only from Q2 to Q4., Discussion: Our real-world data provide evidence that higher age, male gender, and migration background are currently associated with lower use of diabetes technology in adults with T1D in Germany. Associations with area deprivation are more complex, probably due to correlations with other factors, like the higher proportion of migrants in less deprived areas or the federal structure of the German health care system., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Auzanneau, Eckert, Meyhöfer, Heni, Gillessen, Schwettmann, Jehle, Hummel and Holl.)

Background: A paucity of reports in the literature exists concerning the co‐existence between autism spectrum disorder (ASD) and type 1 diabetes (T1D). Objective: To compare clinical characteristics, diabetes management and metabolic control in youth with T1D and ASD (T1D‐ASD) with youth without ASD (T1D‐non ASD). Methods: Using the German/Austrian diabetes patient follow‐up registry, this study analyzed aggregated data from the last available year of observation for each patient with T1D, ages 1‐20 with consistent data on insulin regimen and glycated hemoglobin (A1C), between January, 2005 and March, 2017. Results: From 61 749 patients, 150 (0.24%) were identified as T1D‐ASD. Non‐adjusted comparisons showed similar results for mean age at onset and duration of diabetes, but not for gender (male: T1D‐ASD: 85.3%; T1D‐non ASD: 52.8%; P < .001). Unadjusted comparisons showed no difference for severe hypoglycemia, diabetic ketoacidosis, insulin doses, insulin pump therapy, and body mass index. A statistical difference was observed for A1C (P‐value .01) and in the number of blood glucose (SMBG) tests/day (median [interquartile range]: T1D‐ASD 6.0 [4.4‐7.0]; T1D‐non ASD 5.0 [4.4‐7.0]; P‐value < .001). After adjusting for age, gender, duration of diabetes, and year of observation, only SMBG remained significant (P‐value .003). T1D‐ASD used psycho‐stimulants (15.3% vs 2.2%; P‐value < .001), antipsychotics (10.7% vs 0.6%; P‐value < .001), and antidepressive medications (3.6% vs 0.7%; P‐value < .001) more frequently. Conclusion: Metabolic control was similar in the T1D‐ASD group compared to T1D‐non ASD despite their comorbidity. Awareness of ASD remains important in T1D treatment, as both conditions require long‐term multi‐disciplinary medical follow‐up for optimal outcomes. [ABSTRACT FROM AUTHOR]

Objective: To examine glycemic control in youth with type 1 diabetes (T1D) who switched from multiple daily injections (MDI) to a tubeless insulin pump (Omnipod Insulin Management System, Insulet Corporation, Billerica, Massachusetts) compared to patients who continued MDI therapy over a 3‐year time period. Research Design and Methods: This retrospective analysis of the German/Austrian Diabetes Patienten Verlaufsdokumentation registry included data from 263 centers and 2529 patients <20 years (n = 660 tubeless insulin pump; n = 1869 MDI) who initiated treatment on a tubeless insulin pump as of January 1, 2013 and had 1 year of data preswitch from MDI and 3 years of data postswitch to a tubeless pump. Outcomes included the change in glycated hemoglobin (HbA1c), insulin dose, and body mass index (BMI) SD score (SDS). Results: Youth with T1D who switched from MDI therapy to a tubeless insulin pump showed better glycemic control at 1 year compared to patients who continued MDI treatment, adjusted mean ± SE: 7.5% ± 0.03% (58 mmol/mol) vs 7.7% ± 0.02% (61 mmol/mol); P < .001, with no between‐group difference at 2 and 3 years. Total daily insulin dose was lower (P < .001) in the tubeless insulin pump group, 0.80 ± 0.01, 0.81 ± 0.01, and 0.85 ± 0.01 U/kg, vs the MDI group, 0.89 ± 0.01, 0.94 ± 0.01, and 0.97 ± 0.01 U/kg, at 1, 2, and 3 years, respectively (all P < .001). BMI SDS increased in both groups and was not different over time. Conclusions: Treatment with a tubeless insulin pump in youth with T1D was associated with improvements in glycemic control compared to MDI after 1 year and appears to be an effective alternative to MDI. [ABSTRACT FROM AUTHOR]

Objective: To investigate the prevalence of asthma in young patients with type 1 diabetes mellitus (T1D) from Austria and Germany and its influence on their metabolic control. Methods: This prospective, multicenter observational cohort study was based on the DPV‐registry (German/Austrian DPV initiative) including 51 926 patients with T1D (<20 years). All clinical data were documented prospectively. To identify patients with additional asthma, the entry of the diagnosis asthma as well as asthma medication was used for classification. Results: 1755 patients (3.4%) of the cohort had the diagnosis asthma or received asthma‐specific drugs. Patients with asthma needed higher insulin doses (0.88 ± 0.3 vs 0.84 ± 0.3 U/kg, P < .01) and had decreased height‐standard deviation score (SDS) (−0.002 ± 1.04 vs 0.085 ± 1.02, P < .01); they were more often males (61% vs 52%, P < .01), had an increased body mass index (BMI)‐SDS (0.31 ± 0.89 vs 0.28 ± 0.89, P = .04) and experienced more severe hypoglycemia (4.5 [4.2; 4.8] vs 3.2 [3.2; 3.3] events/100 pts. years, P < .01). Glycated hemoglobin A1c (HbA1c) did not differ between patients with and without asthma overall, only sub groups (corticosteroids vs leukotriene antagonist and corticosteroids vs sympatomimetics) revealed differences. No influence of asthma medication on metabolic control or BMI‐SDS could be found. Conclusion: In our DPV‐database, frequency of asthma and T1D seems similar to the prevalence of asthma in the healthy German background population. The concomitant diagnosis of asthma and T1D had minor influence on metabolic control and diabetes complication rate, although there was no difference in HbA1c overall. Patients with both diseases seem to be slightly growth restricted and require slightly higher insulin doses. [ABSTRACT FROM AUTHOR]

Objectives: By using pediatric diabetes quality registries in Austria, Germany, and Sweden treatment of type 1 diabetes and the outcome of care during the vulnerable adolescence period were compared. Methods: Data in DPV, broadly used in Austria and Germany, and Swediabkids used in Sweden, from clinical visits in the year 2013 on 14 383 patients aged 11 to 16 years regarding hemoglobin A1c (HbA1c), insulin regimen, body mass index (BMI)‐SD score (SDS), blood pressure, hypoglycemia, ketoacidosis, and smoking habits were analyzed. Results: Patients in Sweden had fewer clinical visits per year (P < .05), lower insulin dose per kg (P < .001), and lower proportion of fast acting insulin compared with Germany and Austria (P < .001). The proportion of pump users was higher in Sweden (P < .001). Patients in Sweden had lower mean HbA1c levels (Austria: 64 mmol/mol, Germany: 63 mmol/mol, and Sweden: 61 mmol/mol [8.0%, 7.9%, and 7.7%, respectively]; P < .001). The frequency of severe hypoglycemia was higher in Sweden while it was lower for ketoacidosis (3.3% and 1.1%, respectively) than in Austria (1.1% and 5.3%) and Germany (2.0% and 4.4%) (P < .001). Girls in all 3 countries had higher HbA1c and BMI‐SDS than boys. Conclusions: Sharing data between diabetes registries and nations enables us to better understand differences in diabetes outcome between countries. In this particular comparison, pediatric patients with diabetes in Sweden were more often treated with insulin pump, had lower HbA1c levels and a higher rate of severe hypoglycemia. Patients in Austria and Germany used rapid acting insulin analogs more often and had a lower rate of ketoacidosis. [ABSTRACT FROM AUTHOR]

Abstract: Aims: Insulin resistance may contribute to the pathogenesis of autoimmune‐mediated diabetes. Antibodies against β‐cell‐associated molecules, comprising islet cell antigen (ICA), glutamic acid decarboxylase (GAD) and insulin, characterize the autoimmune process. Because the link between insulin resistance and autoimmunity might be relevant for disease progression and treatment, we hypothesized that insulin resistance associates positively with β‐cell‐directed antibodies in newly diagnosed Type 1 diabetes. Methods: Within the German Diabetes Study, an observational study including adults with newly diagnosed diabetes, 142 adults [84 men, 58 women; age 33.1 (26.4, 41.9) years; diabetes duration 6.3 (4.2, 9.1) months] positive for at least one antibody against ICA, GAD or insulin underwent hyperinsulinaemic–euglycaemic clamp tests to assess insulin sensitivity (M‐value) in a cross‐sectional setting. Results: Insulin‐directed antibodies were inversely correlated with M‐values (β = −0.039). Albeit not strong, the association persisted after adjustment for age, sex and BMI, and even after further adjustment for confounders reflecting exposure to exogenous insulin and residual β‐cell secretory capacity. Correlation network‐based analyses revealed a complex interaction between levels of fasting insulin and of insulin antibodies with respect to their relationship with the M‐value. GAD‐ or ICA‐directed antibodies did not correlate with insulin sensitivity. Conclusions: In adults with recent‐onset Type 1 diabetes expressing at least one β‐cell‐directed antibody, insulin sensitivity is inversely related to insulin antibody titres, but not to other autoantibodies. Our finding may allow for the identification of insulin resistance in adults with high levels of insulin antibodies. [ABSTRACT FROM AUTHOR]

Background: Increasing evidence link sleep curtailment and circadian misalignment with adverse metabolic outcome. Adolescents might be most affected, given their late sleep timing and early school and work start times. Objective: Our aim was to examine the impact of poor sleeping habits on glycemic control in adolescents with type 1 diabetes. Subjects and Methods: This was a non‐interventional multicenter study across Germany recruiting pubertally mature adolescents with type 1 diabetes. Medical records were used to collect information on diabetes duration, treatment, and complications. Participants self‐reported sleep quality, timing, chronotype, and social jetlag—a measure of circadian misalignment. Hemoglobin A1c (HbA1c) was determined at the time of questionnaire response. We used multivariable linear regression models to examine associations between sleep and glycemic control. Results: A total of 191 patients aged 16.5 years (mean HbA1c 8.0% [64 mmol/mol]) were included in this study. In multivariable adjusted analyses, sleep quality was significantly associated with HbA1c (mean difference; β = −0.07, P = .05). Stratified analysis indicated that this association might be stronger in boys and also in children with migration background. In contrast, neither sleep duration, sleep debt, chronotype, nor social jetlag was associated with HbA1c . Secondary analyses showed that social jetlag was significantly associated with levels of insulin requirements (mean difference; β = 0.035, P = .03). Conclusions: Our study suggests that poor sleep quality is associated with increased HbA1c in adolescents with type 1 diabetes and that higher levels of circadian misalignment are associated with increased insulin requirements. If replicated, our results indicate a clinical relevance of sleep habits in adolescents with type 1 diabetes. [ABSTRACT FROM AUTHOR]

Aims To determine key worries about hypoglycaemia among insulin-using adults with Type 2 diabetes using a focus group approach. Methods Thirteen focus groups were conducted in three diabetes outpatient care units and one peer support group was set up, in Germany. A total of 64 insulin-dependent adults with Type 2 diabetes (36.5% women, mean age 65.2 ± 11.0 years) discussed their worries about hypoglycaemia. The qualitative results were assigned into thematic categories using a bottom-up coding procedure. Participants completed the Hypoglycaemia Fear Survey and demographic measures were recorded. The results of the Hypoglycaemia Fear Survey were contrasted with the focus group findings to evaluate how accurately the Hypoglycaemia Fear Survey comprehensively captures features of fear of hypoglycaemia in Type 2 diabetes. Results Eight themes were identified: 'unconsciousness/death'; 'aloneness/ helplessness', 'fear of hurting somebody'; 'shame'; 'loss of physical control'; 'long-term complications'; 'diabetes self-management issues'; and 'impaired awareness'. A total of 30 participants (46.9%) scored ≥3 on at least one item of the Hypoglycaemia Fear Survey worry subscale, indicating elevated worries. The Hypoglycaemia Fear Survey comprehensively captured all identified themes. Self-efficacy with regard to diabetes self-management seemed to play an important role in fear of hypoglycaemia in Type 2 diabetes. Conclusions Given that even subclinical worries can have negative effects on quality of life and diabetes self-management, emphasis should be placed on diabetes education; in particular, to help patients to develop self-efficacy concerning diabetes self-management. The Hypoglycaemia Fear Survey comprehensively captures hypoglycaemia worries in Type 2 diabetes. Additional assessment of self-efficacy might be beneficial to identify people at risk of developing hypoglycaemia worries. [ABSTRACT FROM AUTHOR]

Objective Insulin dose-adjusted hemoglobin A1c (HbA1C, IDAA1c) correlates well with stimulated C-peptide levels, but has not yet been evaluated in a large cohort of patients with Type 1 diabetes (T1D). Methods We investigated prevalence of partial remission (PREM) defined by IDAA1c ≤9 in 3657 in children with new-onset T1D who were continuously followed over 6 years. We evaluated the predictors of PREM using the multicenter database from the DPV (Diabetes Patienten Verlaufsdokumentation) registry. Results PREM occurred in 71% of patients. Median duration was 9 (0-21) months. Compared to children <5 years at T1D onset, those aged 5-10 and ≥10 years had twice the chance of developing PREM (OR: 2.08, CI: 1.67-2.60; P < .001 and OR: 2.16, CI: 1.70-2.75; P < .001). Boys were more likely to develop PREM than girls (OR 1.41, CI: 1.18-1.69; P = .0002). Further predictors for PREM were: ketoacidosis, autoantibodies, and HbA1c at T1D onset. These results were confirmed by quantile regression analysis with duration of PREM as dependent variable. Conclusion This research on a large cohort provides insight into epidemiologic characteristics of PREM in T1D defined by IDAA1c. As IDAA1c does not discriminate between insulin sensitivity and secretion, available data cannot resolve whether the sex-difference in PREM reflects innate higher insulin resistance in girls, or better beta-cell recovery in boys. Further research is needed to clarify the usefulness and performance of IDAA1c in clinical practice. [ABSTRACT FROM AUTHOR]

Objective: To assess parent anxiety in response to genetic and islet autoantibody (IA) testing in children at increased genetic risk for type 1 diabetes followed from birth in The Environmental Determinants of Diabetes in the Young (TEDDY) study.Research Design and Methods: Parent anxiety about TEDDY children's risk was assessed with the State Anxiety Inventory (SAI). Parents completed the SAI when the child was 3, 6, and 15 months old and annually thereafter. Children were tested for IA every 3 months for 4 years and every 6 months thereafter. Parent SAI scores of 6,799 children followed with IA testing for at least 1 and up to 6 years were examined.Results: At study inception, parents showed high levels of anxiety in response to their child's increased genetic type 1 diabetes risk; mothers were more anxious than fathers, and parents with diabetes in the family were more anxious than parents with no family history. In response to repeated IA-negative (IA-) test results, parent anxiety declined to normal levels. Anxiety increased in parents faced with an IA-positive (IA+) test result. Parents faced with two or more types of IA+ test results showed particularly high levels of anxiety (all P < 0.001).Conclusions: Infant genetic screening for type 1 diabetes raises parent anxiety when the child is at increased risk, but anxiety dissipates over time in cases of repeated IA- results. IA+ results heighten parent anxiety, and parents faced with two or more types of IA+ results may experience considerable anxiety for longer periods. [ABSTRACT FROM AUTHOR]

Background Insulin-delivery algorithms for achieving glycemic control in the intensive care unit require frequent checks of blood glucose level and thus increase nursing workload. Hypoglycemia is a serious complication associated with intensive insulin therapy. Qbtectives To evaluate a nurse-directed protocol for blood glucose management that allows individualized insulin delivery within a predefined blood glucose corridor, intended to avoid hypoglycemia while maintaining adequate control of blood glucose level without increasing nursing workload. Methods A nurse-directed protocol for blood glucose management was developed by an interprofessional team, and the protocol's performance was investigated in 175 patients compared with 384 historical controls. Results With the nurse-directed protocol, hypoglycemia incidents declined significantly (31% vs 12%, P < .001), and minimum blood glucose levels increased significantly (80 mg/dL vs 93 mg/dL, P < .001). Mean and maximum blood glucose levels, the proportion of glucose readings within the target range (31% vs 26%, P = .06), and the number of blood glucose checks (59 vs 58, P = .85) remained unchanged with use of the protocol. Conclusion Implementation of the nurse-directed protocol for blood glucose management did not increase nursing workload but reduced hypoglycemia incidents significantly while maintaining adequate glycemic control. [ABSTRACT FROM AUTHOR]

Aims To examine the hypothesis that changes in serum adiponectin concentration inversely relate to changes in glucose tolerance and β-cell function already during the early stage of disease progression in recently diagnosed Type 1 and Type 2 diabetes mellitus. Methods Participants in the prospective observational German Diabetes Study (Type 2 diabetes, n = 94; Type 1 diabetes, n = 42) underwent i.v. glucose tolerance and glucagon stimulation testing to assess pre-hepatic β-cell function, glucose tolerance index and C-peptide secretion within the first year of diabetes diagnosis and 2 years later. Associations of changes in serum concentrations of total adiponectin, high-molecular-weight adiponectin and their ratio with changes in the aforementioned metabolic variables were calculated using linear regression. Results Among people with Type 2 diabetes, 2-year increases in high-molecular-weight adiponectin and in high-molecular-weight/total adiponectin ratio were associated with decreases in glucose tolerance index of 0.1%/min ( P = 0.020) and 0.8%/min ( P = 0.013), respectively. Increases in high-molecular-weight/total adiponectin ratio were related to decreases in acute C-peptide secretion of 54.6% ( P = 0.020). Among people with Type 1 diabetes, 2-year increases in total adiponectin were associated with 2-year decreases in acute C-peptide secretion of 56.2% ( P = 0.035). Conclusions Increases in adiponectin concentrations in the first 2 years after diagnosis were related to a worsening of acute insulin secretion and glucose tolerance index in Type 1 and Type 2 diabetes. (Clinical Trials Registry no.: NCT01055093) [ABSTRACT FROM AUTHOR]

Aims To compare the clinical and metabolic characteristics of patients with Type 1 diabetes and necrobiosis lipoidica with those of patients with Type 1 diabetes who do not have necrobiosis lipoidica. A multicentre analysis was performed. Methods Clinical and laboratory data were obtained from 64 133 patients (aged 0-25 years) with Type 1 diabetes with and without necrobiosis lipoidica who were registered in the German/Austrian Diabetes Prospective Documentation Initiative registry. Data were analysed using multivariable regression modelling. Age, diabetes duration, treatment year and sex were considered as confounding factors. Results Results adjusted for demographic variables are presented. In patients with necrobiosis lipoidica, metabolic control was worse (HbA1c 72 vs. 67 mmol/mol, 8.7% vs. 8.3%; P = 0.0065) and the duration of diabetes was longer [6.24 (3.28-9.97) vs. 5.11 (2.08-8.83) years; P = 0.014; not adjusted]. Patients with necrobiosis lipoidica required higher insulin doses than those without (1.02 vs. 0.92 U/kg/day; P < 0.0001). There was no significant difference in the frequency of microvascular complications (microalbuminuria and retinopathy) between the groups. Furthermore, 24.8% and 17.5% of patients with Type 1 diabetes with and without necrobiosis lipoidica, respectively, had elevated thyroid antibodies ( P = 0.051). Necrobiosis lipoidica was correlated with coeliac disease in patients with Type 1 diabetes (3.4% vs. 1.0%; P = 0.0035). Conclusions Our data indicate a strong correlation between hyperglycaemia and the development of necrobiosis lipoidica. We postulate that the underlying pathogenic processes differ from those leading to microalbuminuria and retinopathy, and additional immunological mechanisms may play a role. [ABSTRACT FROM AUTHOR]

Background Diabetes education of patients and/or parents is an essential part of diabetes care with effects on diabetes outcome. The objective of our study was to describe the current practice of diabetes education in Germany and Austria with regard to training frequency, patient age, migration background and diabetes therapy in a large cohort of pediatric patients with diabetes mellitus type 1 ( T1DM). Methods We analyzed data from pediatric T1DM patients with diabetes training in 2013 and complete data available for treatment year in the multicenter Diabetes Patienten Verlaufsdokumentation ( DPV) registry using sas 9.4. Results In 2013 21 871 pediatric patients with T1DM were documented [52.4% male, age: 12.70 (9.35-15.30) yr (median (interquartile range)], diabetes duration: 3.80 (1.45-7.00) yr, migration background: 21.4%, twice daily injections: 5.5%, multiple daily injections: 52.5%, insulin-pump therapy: 42%. Of these 32.31% were trained in 2013. Younger patients and their parents were trained more intensely and more frequently as inpatients compared with older patients (0-6 vs. 6-12 and 12-18 yr: teaching units: 13.07 vs. 12.05 and 9.79; inpatient: 79% vs. 72% and 70%). There was also a difference in training frequency with regard to migration background. Severe hypoglycemia or ketoacidosis resulted in intensification of training (4.0 vs. 2.0%; 7.8 vs. 3.1%). Centre-specific education tools were used frequently alone or in combination with published, standardized education programs. Conclusion Training frequency was highest in younger patients and during the first year of diabetes. Acute complications resulted in more frequent diabetes training, indicating that currently many education sessions take place in consequence to these complications. [ABSTRACT FROM AUTHOR]

Background: To investigate changes in diabetes treatment over the last two decades in three age-groups of children and adolescents with type 1 diabetes (T1D) from Germany and Austria. Methods: 63,967 subjects (<18yr) with T1D documented between 1995 and 2014 from the DPV-database were included and stratified according to age (0.5-<6, 6-<12, 12-<18yr). Regression models were applied for insulin regimens (<3 and ≥4 injection time points/day, or continuous subcutaneous insulin infusion (CSII)), use of rapid- and long acting insulin analogues, NPH insulin, and frequency of self-monitoring of blood glucose (SMBG)/day. Models were adjusted for sex, diabetes duration, and migration background. P-value for trend was given. Findings: The number of subjects with <3 injection time points/day decreased from 1995 to 2014 to <5% in all age-groups (p<0.0001). Proportion of patients with ≥4 injections/day increased until the early 2000s, and then declined until 2014. This trend was not found in 6-<12yr olds (p = 0.3403). CSII increased in all age-groups (p<0.0001) with the highest increase in children <6 years (from 0.4% to 79.2%), and the lowest increase in 12-<18 year olds (from 1.0% to 38.9%). NPH insulin decreased in all age-groups (p<0.0001). Insulin analogues, especially rapid-acting, became more frequent in all age-groups (p<0.0001), accounting for 78.4% in 2014 for all subjects. The highest use was found in the youngest children (in 2014: 85.6%), the lowest use in 6-<12 year olds (in 2014: 72.9%). The number of SMBG/day increased from 2.2 to 6.4 with a similar rise in all age-groups (p<0.0001). Frequency was highest in subjects <6yr. Conclusions: In all age-groups, T1D treatment was intensified over the last 20 years. Age-specific differences in trends were particularly observed in the number of patients on CSII, in the number of patients with 4 or more injections/day, and in the frequency of SMBG/day. [ABSTRACT FROM AUTHOR]

Objective: Research on β-cell autoimmunity in cystic fibrosis (CF)-related diabetes (CFRD) is still rare. We aimed to analyze the frequency of β-cell autoimmunity and the influence on age at diabetes onset, insulin requirement, type of insulin therapy, and hypoglycemic or ketoacidotic events in patients with CFRD compared with antibody-negative patients with CFRD in the Diabetes Patienten Verlaufsdokumentation (DPV) registry.Research Design and Methods: We analyzed data of 837 patients with CFRD in the German/Austrian DPV database by multivariable mixed-regression modeling.Results: In our cohort, 8.5% of patients with CFRD (n = 72) were found to be β-cell antibody positive. There was a female preponderance in this patient group: 65.3 vs. 57.6%. Diabetes onset (median [interquartile range]) was earlier (14.00 [10.15-15.90] vs. 16.10 [13.50-21.20] years; P < 0.005), and insulin dose/kg body weight was higher (0.95 [0.61-1.15] vs. 0.67 [0.33-1.04] IU/kg; P < 0.05). There were also differences in the type of insulin treatment. Insulin pump therapy was used significantly more often in patients with CFRD with β-cell autoimmunity (18.2 vs. 6.4%; P < 0.05). The differences for multiple daily injections (ICT) and conventional therapy (CT) were not significant (ICT: 67.7 vs. 79.0%; CT: 15.2 vs. 14.6). Oral antidiabetic agents were rarely used in both groups. Rate of severe hypoglycemia with coma and rate of ketoacidosis were higher in antibody-positive patients (hypoglycemia with coma: 8.0 vs. 1.4, P < 0.05; ketoacidosis: 9.3 vs. 0.9, P < 0.05).Conclusions: Presence of β-cell autoantibodies in our cohort of patients with CFRD (8.5%) appeared to be greater than in the general population and was associated with female sex, earlier onset of diabetes, and higher insulin requirement. Insulin pump therapy was used significantly more often in patients with β-cell antibodies. Severe hypoglycemia and ketoacidosis were significantly more frequent in CFRD with β-cell autoimmunity compared with β-cell antibody-negative patients with CFRD. [ABSTRACT FROM AUTHOR]

Background: Evidence is growing that air pollutants deteriorate glucose metabolism and insulin sensitivity by oxidative stress and inflammation. This might affect HbA1c levels and insulin requirements in type 1 diabetes. There are no data available on this association.Methods: Air pollution values of respirable particulate matter (PM10), nitrogen dioxides (NO2), and accumulated ozone (O3-AOT40) were obtained from the federal environmental agency (Umweltbundesamt II) and assigned to place of residence of 840 participants from a nation-wide population-based type 1 diabetes registry (German Diabetes Center, Düsseldorf, Germany). Information on HbA1c, social status, treatment and co-morbidities was collected by self-administered questionnaires. Complete information was available for 771 patients aged 11-21 years at the time of study.Results: In linear regression models, no adverse effects of air pollutants (PM10, NO2 or O3-AOT40 on HbA1c level were found, but O3-AOT40 was inversely associated with HbA1c (mmol/mol) in the crude (estimate per IQR: -1.86; 95% CI: (-3.27; -0.44); p=0.01) and the best model adjusting for lifestyle, socioeconomic factors, clinical information, and season (-1.50; (-2.82; -0.17); 0.034). After adding area of residency as random effect to the crude and the best model, the association was no longer significant (-1.64; (-3.84; 0.56); 0.14); (-1.56; (-3.67; 0.55); 0.14). Adjustment for further possible confounders did not affect the estimates seriously. None of the pollutants was associated with insulin dose (IU/kg body weight).Conclusions: Investigated pollutants had no adverse effect on metabolic control in children and young adults with type 1 diabetes in this cross-sectional study. The weak inverse association of accumulated ozone with HbA1c might be due to confounding by regional characteristics or regional aspects of care. [ABSTRACT FROM AUTHOR]

Purpose: Using ob/ ob mice as a model of non-alcoholic fatty liver disease (NAFLD), we investigated the effect of moderate alcohol intake on the development of NAFLD and molecular mechanisms involved. Methods: Ob/ ob mice were fed water or ethanol solution (2.5 g/kg body weight/day) for 6 weeks, and markers of liver injury, insulin signalling and adiponectin in visceral adipose tissue were determined. Results: Whereas bodyweight and the degree of liver steatosis did not differ among ob/ ob mouse groups, those consuming ethanol had markedly less macrovesicular hepatic fat accumulation, inflammatory alterations and significantly lower transaminase levels. Despite similarly elevated protein levels of tumour necrosis factor α, protein concentrations of plasminogen activator inhibitor 1 were significantly lower in livers of ob/ ob mice consuming ethanol in comparison with controls. The hepato-protective property of moderate alcohol ingestion in ob/ ob mice was associated with an induction of the sirtuin-1/adiponectin-signalling cascade in visceral fat tissue and an activation of Akt in the liver. Similar effects of moderate alcohol exposure were also found in vitro in 3T3-L1 and AML-12 cells. Conclusion: These data suggest that moderate alcohol intake may diminish the development of NAFLD through sirtuin-1/-adiponectin-dependent signalling cascades. [ABSTRACT FROM AUTHOR]

Background: Decreased bone mineral density (BMD) has been linked to metabolic disorders, such as type 2 diabetes. However, results regarding the metabolic syndrome (MetS), a cluster of at least 3 of 5 cardiovascular risk parameters with potentially contradictory effects on BMD are still inconclusive. Objective: We investigated the effect of MetS and its single parameters on BMD at 3 sites in community-dwelling older subjects. Methods: 1,402 subjects (51.1% female, 68 ± 4 years old) from the Berlin Aging Study II (BASE-II) were included. MetS was defined as suggested by IDF/NHLBI/AHA. Insulin resistance (IR) was assessed by the homeostasis model of IR. BMD (lumbar spine, femur neck, hip) and trunk fat were measured by dual-energy X-ray absorptiometry. Osteoporosis was defined by a T score of ≤-2.5. Results: MetS was present in 29.6% of women and 41.7% of men. In regression models, we observed a positive association of MetS with the BMD of the lumbar spine (p = 0.005) and hip (p = 0.028) in women even after adjustment for risk factors, but no effect of the single parameters apart from IR. In contrast, there was no association between MetS and BMD in men. However, higher trunk fat and higher waist circumference were associated with lower levels of BMD in men with or without MetS (p < 0.05). Conclusion: We obtained different results in men and women. In women, the positive though slight effect of MetS on BMD could not be explained by single MetS components apart from IR. In men, central obesity was negatively associated with BMD, suggesting that the metabolic effects driven by visceral fat have a negative impact. [ABSTRACT FROM AUTHOR]