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Background: CamAPS FX is a hybrid closed-loop smartphone app used to manage type one diabetes. The closed-loop algorithm has a default target glucose of 5.8 mmol/L (104.5 mg/dL), but users can select personal glucose targets (adjustable between 4.4 mmol/L and 11.0 mmol/L [79 mg/dL and 198 mg/dL, respectively])., Method: In this post-hoc analysis, we evaluated the impact of personal glucose targets on glycemic control using data from participants in five randomized controlled trials., Results: Personal glucose targets were widely used, with 20.3% of all days in the data set having a target outside the default target bin (5.5-6.0 mmol/L [99-108 mg/dL]). Personal glucose targets >6.5 mmol/L (117 mg/dL) were associated with significantly less time in target range (3.9-10.0 mmol/L [70-180 mg/dL]; 6.5-7.0 mmol/L [117-126 mg/dL]: mean difference = -3.2 percentage points [95% CI: -5.3 to -1.2; P < .001]; 7.0-7.5 mmol/L [126-135 mg/dL]: -10.8 percentage points [95% CI: -14.1 to -7.6; P < .001]). Personal targets >6.5 mmol/L (117 mg/dL) were associated with significantly lower time (<3.9 mmol/L [<70 mg/dL]; 6.5-7.0 mmol/L [117-126 mg/dL]: -1.85 percentage points [95% CI: -2.37 to -1.34; P < .001]; 7.0-7.5 mmol/L [126-135 mg/dL]: -2.68 percentage points [95% CI: -3.49 to -1.86; P < .001])., Conclusions: Discrete study populations showed differences in glucose control when applying similar personal targets., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: C.K.B. has received consulting fees from CamDiab and speaker honoraria from Ypsomed. J.W. has received speaker honoraria from Ypsomed. J.M.A. has received consulting fees from CamDiab. S.H. serves as a member of Sigma (Dexcom) and Medtronic advisory boards; is a consultant for CamDiab and a director of Ask Diabetes Ltd., providing training and research support in healthcare settings; and reports having received training honoraria from Medtronic, Sanofi, and Ypsomed. M.E.W. reports receiving license fees from B. Braun, patents related to closed-loop systems, and being a consultant at CamDiab. C.d.B. reports having received speaker honoraria from Medtronic and has served on the EU psychology e-learning board of Medtronic. E.F.-R. reports having received speaker honoraria from Medtronic, Eli Lilly and Company, Novo Nordisk, and Sanofi and serving on the advisory board for Eli Lilly and Company. S.E.H. has received speaker honoraria from Medtronic, Eli Lilly, Ypsomed, and Insulet. T.M.K. reports having received speaker honoraria from Eli Lilly, Merck Serono, and Novo Nordisk. B.R.-M. has received speaker honoraria from Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk, Roche Diabetes Care, Sanofi, and Menarini and has been on the advisory boards of Eli Lilly, Roche Diabetes Care, and Abbott Diabetes Care. T.L.R. has received consultancy fees from Abbott Diabetes Care and speaker honoraria from Novo Nordisk. R.E.J.B. reports having received speaking honoraria from Eli Lilly and Springer Healthcare and sits as an unpaid member of the Novo Nordisk UK Research Foundation grant and selection committee. L.D. has received honoraria for taking part in an Interactive Advisory and Advocacy Forum on CGM Use in Pediatric Clinical Practice from Dexcom and has received conference fees from Novo Nordisk. H.T. reports having received research support from Dexcom and speaker honoraria from Eli Lilly and Dexcom. L.L. reports having received speaker honoraria from Animas, Abbott, Insulet, Medtronic, Novo Nordisk, Roche, and Sanofi; was on advisory panels for Animas, Abbott, Novo Nordisk, Dexcom, Medtronic, Sanofi, and Roche; and received research support from Novo Nordisk and Dexcom. M.L.E. reports having received speaker honoraria from Eli Lilly and Company, Novo Nordisk, Abbott Diabetes Care, Medtronic, AstraZeneca, and Ypsomed and acting on advisory boards for Medtronic, Novo Nordisk, Zucara Therapeutics, Pila Pharma, and Abbott Diabetes Care. J.K.M. is a member of the advisory boards of Abbott Diabetes Care, BD, Boehringer Ingelheim, Eli Lilly and Company, Medtronic, Novo Nordisk AS, Prediktor A/S, Roche Diabetes Care, and Sanofi; received speaker honoraria from Abbott Diabetes Care, AstraZeneca, Dexcom, Eli Lilly and Company, Menarini Diagnostics, Novo Nordisk A/S, Roche Diabetes Care, Servier, and Ypsomed; and is a cofounder and shareholder of decide Clinical Software Ltd. R.H. reports having received speaker honoraria from Eli Lilly and Company, Dexcom, and Novo Nordisk; receiving license fees from Medtronic; receiving patents related to closed-loop systems; and being the director at CamDiab. M.F., A.T., F.M.C., A.G., D.E., N.T., N.D., and L.B. have no conflict of interest to disclose.

Background: Lipohypertrophy is a common complication in patients with diabetes receiving insulin therapy. There is a lack of consensus regarding how much lipohypertrophy affects diabetes management. Our study aimed to assess the potential correlation between lipohypertrophy and glycemic control, as well as insulin dosing in patients with diabetes. Methods: We performed a systematic review followed by a meta-analysis to collect data about glycemic control and insulin dosing in diabetic patients with and without lipohypertrophy. To identify relevant studies published in English, we searched medical databases (MEDLINE/PubMed, Embase, and CENTRAL) from 1990 to January 20, 2023. An additional hand-search of references was performed to retrieve publications not indexed in medical databases. Results of meta-analyses were presented either as prevalence odds ratios (pORs) or mean differences (MDs) with 95% confidence intervals (95% CIs). This study was registered on PROSPERO (CRD42023393103). Results: Of the 5540 records and 240 full-text articles screened, 37 studies fulfilled the prespecified inclusion criteria. Performed meta-analyses showed that patients with lipohypertrophy compared with those without lipohypertrophy were more likely to experience unexplained hypoglycemia (pOR [95% CI] = 6.98 [3.30-14.77]), overall hypoglycemia (pOR [95% CI] = 6.65 [1.37-32.36]), and glycemic variability (pOR [95% CI] = 5.24 [2.68-10.23]). Patients with lipohypertrophy also had higher HbA1c (MD [95% CI] = 0.55 [0.23-0.87] %), and increased daily insulin consumption (MD [95% CI] = 7.68 IU [5.31-10.06]). Conclusions: These results suggest that overall glycemic control is worse in patients with lipohypertrophy than in those without this condition.

Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC) that are used to evaluate CGM performance, impairs comparability. For this article, several experts in the field of CGM performance testing have collaborated to propose characteristics of the distribution of comparator measurements that should be collected during CGM performance testing. Specifically, it is proposed that at least 7.5% of comparator BG concentrations are <70 mg/dL (3.9 mmol/L) and >300 mg/dL (16.7 mmol/L), respectively, and that at least 7.5% of BG-RoC combinations indicate fast BG changes with impending hypo- or hyperglycemia, respectively. These proposed characteristics of the comparator data can facilitate the harmonization of testing conditions across different studies and CGM systems and ensure that the most relevant scenarios representing real-life situations are established during performance testing. In addition, a study protocol and testing procedure for the manipulation of glucose levels are suggested that enable the collection of comparator data with these characteristics. This work is an important step toward establishing a future standard for the performance evaluation of CGM systems.

Background: The aim of this study was to compare patient-reported outcomes (PROs) in people with type 1 diabetes using either continuous subcutaneous insulin infusion (CSII) with two different insulin patch pumps or multiple daily injections (MDIs)., Materials and Methods: In this randomized three-arm study, people with type 1 diabetes on MDI therapy were included and used either MDI, the Accu-Chek Solo micropump system (Solo) or Omnipod for 26 weeks. From weeks 26 to 39, all participants used CSII with Solo. Patient-reported outcomes were assessed using the diabetes technology questionnaire (DTQ); in addition, HbA 1c values were measured., Results: Overall, 181 participants were randomized (61 MDI arm, 62 Solo arm, 58 Omnipod arm) and 142 completed the study. After 26 weeks in the study, the DTQ "change" score in the Solo group (105.9 [100.6-111.2]; baseline-adjusted mean [95% confidence interval]) was significantly higher than in the MDI group (94.8 [89.6-100.0]) ( P = .001). The comparison between the Solo group (105.1 [99.1-111.1]) and the Omnipod group (108.7 [103.1-114.4]) showed no significant differences ( P = .382). HbA 1c increased by 0.2% ± 0.7% in the MDI group and decreased in both pump groups (Solo group -0.2% ± 0.8% and Omnipod group -0.1% ± 0.8%). Differences in HbA 1c between the Solo group and the MDI group were significant ( P = .009), but not between the Solo group and the Omnipod group ( P = .896)., Conclusions: This study showed that switching from MDI to CSII improves both psychosocial well-being and physiological outcomes. Furthermore, there were no substantial differences between the established and the recently released patch pump. Trial registration at www.clinicaltrials.gov is NCT03478969., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: KBK has declared no conflict of interest. F.T. has declared no conflict of interest. J.K.M. is a member of the advisory board of Abbott Diabetes Care, Becton-Dickinson, Boehringer Ingelheim, Eli Lilly, Embecta, Medtronic, Novo Nordisk A/S, Prediktor A/S, Roche Diabetes Care, Sanofi-Aventis, and Viatris and received speaker honoraria from Abbott Diabetes Care, AstraZeneca, Boehringer Ingelheim, Dexcom, Eli Lilly, Menarini, MSD, Novo Nordisk A/S, Roche Diabetes Care, Sanofi, Servier, and Ypsomed. N.O. has participated in advisory boards for Medtronic Diabetes, Roche Diabetes Care, and Dexcom, has received speaker fees from Dexcom, and has received research funding from Medtronic Diabetes, Roche Diabetes Care, and Dexcom. E.F. has declared no conflict of interest. N.D., T.E., T.K., G.V., and I.V. are employees of Roche Diabetes Care GmbH.

Background: Automated insulin delivery (AID) systems have shown to improve glycemic control in a range of populations and settings. At the start of this study, only one commercial AID system had entered the Austrian market (MiniMed 670G, Medtronic). However, there is an ever-growing community of people living with type 1 diabetes (PWT1D) using open-source (OS) AID systems., Materials and Methods: A total of 144 PWT1D who used either the MiniMed 670G (670G) or OS-AID systems routinely for a period of at least three to a maximum of six months, between February 18, 2020 and January 15, 2023, were retrospectively analyzed (116 670G aged from 2.6 to 71.8 years and 28 OS-AID aged from 3.4 to 53.5 years). The goal is to evaluate and compare the quality of glycemic control of commercially available AID and OS-AID systems and to present all data by an in-depth descriptive analysis of the population. No statistical tests were performed., Results: The PWT1D using OS-AID systems spent more time in range (TIR) 70-180 mg/dL (81.7% vs 73.9%), less time above range (TAR) 181-250 mg/dL (11.1% vs 19.6%), less TAR >250 mg/dL (2.5% vs 4.3%), and more time below range (TBR) 54-69 mg/dL (2.2% vs 1.7%) than PWT1D using the 670G system. The TBR <54 mg/dL was comparable in both groups (0.3% vs 0.4%). In the OS-AID group, median glucose level and glycated hemoglobin (HbA1c) were lower than in the 670G system group (130 vs 150 mg/dL; 6.2% vs 7.0%)., Conclusion: In conclusion, both groups were able to achieve satisfactory glycemic outcomes independent of age, gender, and diabetes duration. However, the PWT1D using OS-AID systems attained an even better glycemic control with no clinical safety concerns., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: ISF received speaker honoraria from Dexcom, Medtronic, Abbott, and Roche Diabetes Care. BRM reports speaker’s honoraria/advisory board activity from Dexcom, Abbott, Insulet, Medtronic, Eli Lilly, Novo Nordisk, Sanofi, and Ypsomed. JKM is a member of the advisory boards of Abbott Diabetes Care, Becton-Dickinson, Boehringer Ingelheim, Eli Lilly, Embecta, Medtronic, NovoNordisk A/S, Roche Diabetes Care, Sanofi-Aventis, and Viatris, and received speaker honoraria from A.Menarini Diagnostics, Abbott Diabetes Care, AstraZeneca, Boehringer Ingelheim, Dexcom, Eli Lilly, Medtrust, MSD, NovoNordisk A/S, Roche Diabetes Care, Sanofi, Servier, and Ypsomed; furthermore, she is shareholder of decide Clinical Software GmbH and elyte Diagnostics where she also serves as chief marketing officer (CMO). The other authors declare no conflict of interest.

People living with diabetes have many medical devices available to assist with disease management. A critical aspect that must be considered is how systems for continuous glucose monitoring and insulin pumps communicate with each other and how the data generated by these devices can be downloaded, integrated, presented and used. Not only is interoperability associated with practical challenges, but also devices must adhere to all aspects of regulatory and legal frameworks. Key issues around interoperability in terms of data ownership, privacy and the limitations of interoperability include where the responsibility/liability for device and data interoperability lies and the need for standard data-sharing protocols to allow the seamless integration of data from different sources. There is a need for standardised protocols for the open and transparent handling of data and secure integration of data into electronic health records. Here, we discuss the current status of interoperability in medical devices and data used in diabetes therapy, as well as regulatory and legal issues surrounding both device and data interoperability, focusing on Europe (including the UK) and the USA. We also discuss a potential future landscape in which a clear and transparent framework for interoperability and data handling also fulfils the needs of people living with diabetes and healthcare professionals., (© 2023. The Author(s).)

The introduction of automated insulin delivery (AID) systems has enabled increasing numbers of individuals with type 1 diabetes (T1D) to improve their glycemic control largely. However, use of AID systems is limited due to their complexity and costs associated. The user must wear both a continuously monitoring glucose system and an insulin infusion pump. The glucose sensor and the insulin catheter must be inserted at two different body sites using different insertion devices. In addition, the user must pair and manage the different systems. These communicate with the AID software implemented on the pump or on a third device such as a dedicated display device or smart phone application. These components might be developed and commercialized by different manufacturers, which in turn can cause difficulties for patients seeking technical support. A possible solution to these challenges would be to integrate the glucose sensor and insulin catheter into a single device. This would allow the glucose sensor and insulin catheter to be inserted simultaneously, eliminating the need for pairing, and simplifying system management. In recent years, different technologies have been developed and evaluated in clinical investigations that combine the glucose sensor and the insulin catheter in one platform. The consistent finding of all these studies is that integration has no adverse effect on insulin infusion and glucose measurements provided that certain conditions are met. In this review, we discuss the perceived challenges of such an approach and discuss possible solutions that have been proposed., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MS and AM are full-time employees of PharmaSens AG; JKM is a member of advisory boards of Abbott Diabetes Care, Becton-Dickinson, Boehringer Ingelheim, Eli Lilly, Embecta, Medtronic, NovoNordisk A/S, Roche Diabetes Care, Sanofi-Aventis, Viatris and received speaker honoraria from A. Menarini Diagnostics, Abbott Diabetes Care, AstraZeneca, Boehringer Ingelheim, Dexcom, Eli Lilly, Medtrust, MSD, NovoNordisk A/S, Roche Diabetes Care, Sanofi, Servier, and Ypsomed; she is shareholder of decide Clinical Software GmbH and elyte Diagnostics where she also serves as CMO; GF has received speakers honoraria or consulting fees from Abbott, Ascensia, Berlin Chemie, Boydsense, Dexcom, Lilly, Metronom, MySugr, Novo Nordisk, PharmaSens, Roche, Sanofi, and Terumo; P-YB has received speaker honoraria from Abbott, Eli Lilly, Novo Nordisk, and Sanofi, is chief medical officer for Diabeloop, and served on advisory board panels for Abbott, Dexcom, Insulet, LifeScan, Eli Lilly, Pharmasens, Novo Nordisk, and Sanofi; Peter Diem is member of the PharmaSens AG Board of Directors; Lutz Heinemann is a consultant to several diagnostic and therapeutic companies in the development of new products, he is a shareholder in the Profil Institute for Metabolic Research in Neuss, Germany.

Background: The Hypoglycaemia - MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone app was developed to investigate the impact of hypoglycemia on daily functioning in adults with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus. The app uses ecological momentary assessments, thereby minimizing recall bias and maximizing ecological validity. It was used in the Hypo-METRICS study, a European multicenter observational study wherein participants wore a blinded continuous glucose monitoring device and completed the app assessments 3 times daily for 70 days., Objective: The 3 aims of the study were to explore the content validity of the app, the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and suggestions for future versions of the app., Methods: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief web-based survey and an interview (approximately 1h) to explore their experiences with the app during the Hypo-METRICS study. Thematic analysis of the qualitative data was conducted using both deductive and inductive methods., Results: A total of 18 adults with diabetes (type 1 diabetes: n=10, 56%; 5/10, 50% female; mean age 47, SD 16 years; type 2 diabetes: n=8, 44%; 2/8, 25% female; mean age 61, SD 9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. In total, 3 themes were derived: hypoglycemia symptoms and experiences are idiosyncratic; it was easy to select ratings on the app, but day-to-day changes were perceived as minimal; and instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, 5 themes were derived: helping science and people with diabetes; easy to fit in, but more flexibility wanted; hypoglycemia delaying responses and increasing completion time; design, functionality, and customizability of the app; and limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall and as having a possible, although limited, intervention effect in terms of both hypoglycemia awareness and personal impact., Conclusions: The Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycemia on an individual's daily functioning. Despite suggested improvements, participants' responses indicated that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, real-time assessments may have clinical value for monitoring and reviewing hypoglycemia symptom awareness and personal impact., (©Uffe Søholm, Natalie Zaremba, Melanie Broadley, Johanne Lundager Axelsen, Patrick Divilly, Gilberte Martine-Edith, Stephanie A Amiel, Julia K Mader, Ulrik Pedersen-Bjergaard, Rory J McCrimmon, Eric Renard, Mark Evans, Bastiaan de Galan, Simon Heller, Christel Hendrieckx, Pratik Choudhary, Jane Speight, Frans Pouwer, Hypo-RESOLVE consortium Hypo-RESOLVE consortium. Originally published in JMIR Diabetes (https://diabetes.jmir.org), 29.09.2023.)

Aims: Use of the CamAPS FX hybrid closed loop (CL) system is associated with improved time in range and glycated haemoglobin A1c across the age span, but little is known about its effects on patient-reported outcomes (PROs)., Methods: This open-label, randomized, multi-site study compared CamAPS FX to sensor-augmented pump (SAP) in a sample of older adults (≥60 years) with type 1 diabetes (T1D). Thirty-five older adults completed PROs surveys at the start of the study and after each period of 16 weeks using either CL or SAP. At the end of the study, 19 participated in interviews about their experiences with CL., Results: Results examining the 16 weeks of CL use showed that the overall Diabetes Distress Scale score and two subscales (powerlessness and physician distress) improved significantly along with trust on the Glucose Monitoring Satisfaction Survey. User experience interview responses were consistent in noting benefits of 'improved glycaemic control' and 'worrying less about diabetes'., Conclusion: In this sample of older adults with T1D who have previously shown glycaemic benefit, there are indicators of improved PROs and subjective user experience benefits., (© 2023 Diabetes UK.)

Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data., Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation., Results: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals., Conclusion: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Background and Aims: A preliminary study compared the use of continuous glucose monitoring (CGM) with the use of self-monitored blood glucose (SMBG) by aircraft pilots with insulin-treated diabetes in the United Kingdom, Ireland, and Austria, certified to fly commercial aircraft within the European Aviation Safety Agency ARA.MED.330 protocol. Methods: SMBG and simultaneous interstitial glucose measurements using CGM (Dexcom G6 ® ) were recorded during pre- and in-flight periods. Results: Eight male pilots (seven with type 1 diabetes and one with type 3c diabetes), median age of 48.5 years and median diabetes duration of 11.5 years, participated. The correlation coefficient ( R ) between 874 contemporaneously recorded SMBG and CGM values was 0.843, P  < 0.001. The mean glucose concentration was 8.78 mmol/L (standard deviation [SD] 0.67) using SMBG compared with 8.71 mmol/L (SD 0.85) recorded using CGM. The mean absolute relative difference was 9.39% (SD 3.12). Conclusions: CGM using Dexcom G6 systems is a credible alternative to SMBG for monitoring glucose levels when insulin-treated pilots fly commercial aircraft. The study was registered with Clinical Trials.gov NCT04395378.

We thank Dr. Freckmann et al. [...].

Objective: We aimed to assess whether percentage of time spent in hypoglycemia during closed-loop insulin delivery differs by age group and time of day. Methods: We retrospectively analyzed data from hybrid closed-loop studies involving young children (2-7 years), children and adolescents (8-18 years), adults (19-59 years), and older adults (≥60 years) with type 1 diabetes. Main outcome was time spent in hypoglycemia <3.9 mmol/L (<70 mg/dL). Eight weeks of data for 88 participants were analyzed. Results: Median time spent in hypoglycemia over the 24-h period was highest in children and adolescents (4.4% [interquartile range 2.4-5.0]) and very young children (4.0% [3.4-5.2]), followed by adults (2.7% [1.7-4.0]), and older adults (1.8% [1.2-2.2]); P  < 0.001 for difference between age groups. Time spent in hypoglycemia during nighttime (midnight-05:59) was lower than during daytime (06:00-23:59) across all age groups. Conclusion: Time in hypoglycemia was highest in the pediatric age group during closed-loop insulin delivery. Hypoglycemia burden was lowest overnight across all age groups.

Background: Elective surgery in patients with insulin-treated type 2 diabetes mellitus (T2D) and the admission period in the hospital, comprise a distinctive and challenging situation for physicians, nurses, as well as for the patients themselves. There is a lack of widely accepted evidence-based and standardized approach of care in regard to perioperative management of patients with insulin-treated T2D., Methods: The main purpose of this proof-of-concept study was to investigate whether a standardized insulin and meal regimen on the day of surgery leads to a better management of diabetes in terms of blood glucose (BG) levels. Two different insulin and meal regimens-group A with half of insulin dose given with a standardized postoperative meal and group B with a custom preoperative breakfast and full insulin dose-were compared with Group C with routine care (no meal and no insulin injection on the day of surgery). Each group consisted of 12 to 15 patients. BG measurements were performed pre- and immediately postoperatively, before meals and at bedtime., Results: Both standardized and well-defined insulin and meal regimens resulted in better average BG levels in the perioperative period, especially in the morning after the surgery., Conclusions: In this study, we observed that a standardized perioperative insulin regimen efficiently lowered postoperative BG levels. Providing a custom breakfast and a full insulin dose resulted in lower postoperative BG levels. These approaches were not associated with an increase in hypoglycemic events. Physicians and nursing staff gave positive feedback to the structured and well-defined approaches.

Introduction: The aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes., Materials and Methods: 100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily 'check-ins' (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rs<±0.3) validity., Results: Participants' mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible 'check-ins' (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation <0.06, Standardized Root-Mean-square Residual<0.08). Scales had satisfactory internal consistency (all ω≥0.5), and high test-retest reliability (rs≥0.7). Convergent and divergent validity were demonstrated for most scales., Conclusion: High completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia., Competing Interests: US works for Novo Nordisk A/S (the work for this manuscript was undertaken prior to this employment). UPB has served on advisory boards and received lecture fees from for Novo Nordisk and Sanofi. BDG has received research support from Novo Nordisk. SAA has served on advisory boards for Novo Nordisk and Medtronic and have spoken at educational events sponsored by Novo Nordisk and Sanofi. JKM is a member on the advisory board of Abbott Diabetes Care, Boehringer Ingelheim, Becton-Dickinson, Eli Lilly, Medtronic, Novo Nordisk A/S, Prediktor A/S, Roche Diabetes Care, Sanofi-Aventis and received speaker honoraria from Abbott Diabetes Care, AstraZeneca, Becton-Dickinson, Dexcom, Eli Lilly, MSD, Novo Nordisk A/S, Roche Diabetes Care, Sanofi, and Servier. JKM is a shareholder of decide Clinical Software GmbH. FP has received unrestricted funding for research from Novo Nordisk, Eli Lilly and Sanofi. PC has received personal fees from Abbott, Insulet, Medtronic, Novo Nordisk, Eli Lilly, Sanofi and Dexcom. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The data underlying the results presented in the study are available from the Hypo-RESOLVE data repository for researchers who meet the criteria for access. Please contact Hypo-RESOLVE (chair of the publication committee Professor Stephanie Amiel or principal investigator Professor Pratik Choudhary) for further details: https://hypo-resolve.eu/contact, (Copyright: © 2023 Søholm et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Innovations in syringe and pen needle (PN) technology over the last 100 years have led to important advances in insulin delivery for people with diabetes, paralleling the strides made in developing recombinant DNA human insulin and insulin analogs with varying onset and duration of action. In this review, the history of advances in insulin delivery is described, focusing on progress in syringe, needle, and PN technologies. The early glass and metal syringes that required sterilization by boiling have been replaced by disposable, single-use syringes or pens with clear labeling for precise insulin dosing. The early needles ranging in length from 19 to 26 mm that required manual sharpening against a whetstone have been replaced by syringe needles of 6 mm and PNs of 4 mm in length as slender as 34 gauge. Imaging studies using ultrasound and computed tomography measured the thickness of skin and subcutaneous tissue layers to show feasibility of targeted insulin administration with shorter needles. These developments, coupled with innovations in needle/PN wall and tip structure, have led to improved injection experience for people with diabetes. It is also important to acknowledge the role of injection technique education, together with these advances in injection technology, for improving clinical outcomes and patient satisfaction. With continued projected growth of diabetes prevalence, particularly in developing countries where expensive and complex insulin delivery systems may not be practical, insulin syringes and pens will continue to serve as reliable and cost-effective means of insulin delivery for people with diabetes.

This Guideline represents the recommendations of the Austrian Diabetes Association (ÖDG) on the use of diabetes technology (insulin pump therapy; continuous glucose monitoring, CGM; hybrid closed-loop systems, HCL; diabetes apps) and access to these technological innovations for people with diabetes mellitus based on current scientific evidence., (© 2023. The Author(s).)

This position statement presents the recommendations of the Austrian Diabetes Association for diabetes management of adult patients during inpatient stay. It is based on the current evidence with respect to blood glucose targets, insulin therapy and treatment with oral/injectable antidiabetic drugs during inpatient hospitalization. Additionally, special circumstances such as intravenous insulin therapy, concomitant therapy with glucocorticoids and use of diabetes technology during hospitalization are discussed., (© 2023. The Author(s).)

Hyperglycemia significantly contributes to complications in patients with diabetes mellitus. While lifestyle interventions remain cornerstones of disease prevention and treatment, most patients with type 2 diabetes will eventually require pharmacotherapy for glycemic control. The definition of individual targets regarding optimal therapeutic efficacy and safety as well as cardiovascular effects is of great importance. In this guideline we present the most current evidence-based best clinical practice data for healthcare professionals., (© 2023. The Author(s).)

Background: The aim of this study was to assess and compare the time in range (TIR) of children with type 1 diabetes (T1D) before and during a diabetes summer camp using different therapy modalities. Methods: A retrospective analysis of continuous glucose monitoring (CGM) data collected from 26 children with T1D (mean age: 11.0 ± 1.4 years; 62% female; 62% on insulin pump; Hb1Ac 7.3 ± 0.8% (56.3 ± 8.7 mmol/mol) before and during a 14-day summer camp. CGM methods: 50% intermittently scanned CGM (isCGM) and 50% real-time CGM (rtCGM). No child was using a hybrid closed loop system. Results: Mean TIR during camp was significantly higher than before camp ((67.0 ± 10.7%) vs. 58.2% ± 17.4%, p = 0.004). There was a significant reduction in time above range (TAR) (p = 0.001) and increase in time below range (TBR) (p < 0.001), Children using isCGM showed a more pronounced improvement in TIR during camp compared to rtCGM-users (p = 0.025). The increase in TIR strongly correlated with numbers of scans per day in isCGM-users (r = 0.751, p = 0.003). Compared to isCGM-users, rtCGM-users showed significantly less TBR. The TIR target was met by 30.8% of participants during camp. Conclusion: Glycemic control improved significantly during the camp. However, on average, the therapy goal (TIR > 70%) could not be achieved despite great professional effort.

GlucoTab@MobileCare, a digital workflow and decision support system with integrated basal and basal-plus insulin algorithm was investigated for user acceptance, safety and efficacy in persons with type 2 diabetes receiving home health care by nurses. During a three months study nine participants (five female, age 77 ± 10 years, HbA1c 60 ± 13 mmol/mol (study start) vs. 57 ± 12 mmol/mol (study end) received basal or basal-plus insulin therapy as suggested by the digital system. In total 95% of all suggested tasks (blood glucose (BG) measurements, insulin dose calculations, insulin injections) were performed according to the digital system. Mean morning BG was 171 ± 68 mg/dL in the first study month vs. 145 ± 35 mg/dL in the last study month, indicating a reduced glycemic variability of 33 mg/dL (standard deviation). No hypoglycemic episode < 54 mg/dL occurred. User's adherence was high and the digital system supported a safe and effective treatment. Larger scale studies are needed to confirm findings under routine care., German Clinical Trials Register Id: DRKS00015059., Competing Interests: JM, FS, TP and KD are founders of the decide Clinical Software Ltd. JM is a member in the advisory board of Boehringer Ingelheim, Eli Lilly, Medtronic, Prediktor A/S, Roche Diabetes Care, Sanofi-Aventis and received speaker honoraria from Abbott Diabetes Care, AstraZeneca, Dexcom, Eli Lilly, MSD, NovoNordisk A/S, Roche Diabetes Care, Sanofi, and Servier. FA received speaker honoraria from Eli Lilly, Merck Sharp & Dome, Boehringer Ingelheim, Astra Zeneca, Sanofi Aventis, Amgen and travel grants from Sanofi, Novo Nordisk, Takeda, Merck Sharp & Dome and Amgen. TP is an advisory board member of Novo Nordisk A/S, consultant for Roche Diabetes Care, Novo Nordisk A/S, Eli Lilly & Co, Infineon, Carnegie Bank, shareholder of decide Clinical Software GmbH, and is on speaker’s bureau of Novo Nordisk A/S and Astra Zeneca. The remaining 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 © 2022 Kopanz, Mader, Donsa, Libiseller, Aberer, Pandis, Reinisch-Gratzer, Ambrosch, Lackner, Truskaller, Sinner, Pieber and Lichtenegger.)

Objective: To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers' well-being, fear of hypoglycemia, and sleepiness., Research Design and Methods: We conducted a multinational, open-label, randomized crossover study. Children (age 1-7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization-Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires., Results: Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09)., Conclusions: Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL., (© 2022 by the American Diabetes Association.)

Introduction: Hypoglycaemia is a significant burden to people living with diabetes and an impediment to achieving optimal glycaemic outcomes. The use of continuous glucose monitoring (CGM) has improved the capacity to assess duration and level of hypoglycaemia. The personal impact of sensor-detected hypoglycaemia (SDH) is unclear. Hypo-METRICS is an observational study designed to define the threshold and duration of sensor glucose that provides the optimal sensitivity and specificity for events that people living with diabetes experience as hypoglycaemia., Methods: We will recruit 600 participants: 350 with insulin-treated type 2 diabetes, 200 with type 1 diabetes and awareness of hypoglycaemia and 50 with type 1 diabetes and impaired awareness of hypoglycaemia who have recent experience of hypoglycaemia. Participants will wear a blinded CGM device and an actigraphy monitor to differentiate awake and sleep times for 10 weeks. Participants will be asked to complete three short surveys each day using a bespoke mobile phone app, a technique known as ecological momentary assessment. Participants will also record all episodes of self-detected hypoglycaemia on the mobile app. We will use particle Markov chain Monte Carlo optimization to identify the optimal threshold and duration of SDH that have optimum sensitivity and specificity for detecting patient-reported hypoglycaemia. Key secondary objectives include measuring the impact of symptomatic and asymptomatic SDH on daily functioning and health economic outcomes., Ethics and Dissemination: The protocol was approved by local ethical boards in all participating centres. Study results will be shared with participants, in peer-reviewed journal publications and conference presentations., (© 2022 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Short-term glycemic variability is associated with the risk of hypoglycemia and hyperglycemia in people living with type 1 diabetes and can potentially affect clinical outcomes. Continuous glucose monitoring (CGM) is of increasing importance to evaluate glycemic variability in greater detail. Specific metrics for assessing glycemic variability were proposed, such as the SD of mean glucose level and associated coefficient of variation, and time in target glucose range to guide study designs, therapy and allow people with diabetes more transparency in interpreting their own CGM data. Randomized controlled trials (RCT) and real-world evidence provide complementary information about the efficacy/effectiveness and safety of interventions. Insulin glargine 300 U/mL (Gla-300) has a longer lasting and less variable action than insulin glargine U100 (Gla-100) with a lower risk of hypoglycemia. While insulin degludec U100 (iDeg-100) was associated with lower glucose values but more time below range in one randomized study compared with Gla-300, Gla-300 was associated with a higher per cent time in range, but also above the therapeutic range. However, a real-world study did not find differences during the day between Gla-300 and iDeg-100. The upcoming InRange RCT is the first head-to-head comparison of Gla-300 with iDeg-100 using CGM in an international population using CGM metrics as the primary endpoint. The non-interventional COMET-T real-world study will determine the real-world effectiveness of Gla-300 using CGM metrics and cover a broad spectrum of clinical practice decisions irrespective of the prior basal insulin., Competing Interests: Competing interests: JKM is a member of the advisory board of Abbott Diabetes Care, Boehringer Ingelheim, Becton-Dickinson, Eli Lilly, Medtronic, Novo Nordisk, Prediktor, Roche Diabetes Care, and Sanofi-Aventis and received speaker honoraria from Abbott Diabetes Care, AstraZeneca, Becton-Dickinson, DexCom, Eli Lilly, MSD, Novo Nordisk, Roche Diabetes Care, Sanofi, and Servier. JKM is a shareholder of decide Clinical Software. TD has received speaker’s honoraria and research support from or has consulted for Abbott, AstraZeneca, Boehringer, DexCom, Lilly, Medtronic, Novo Nordisk, Roche, Sanofi and Ypsomed and is a shareholder of DreaMed Ltd. SG has received speaker’s honoraria from Sanofi, Eli Lilly, Novo Nordisk, Abbott Diabetes Care, AstraZeneca, DexCom, VitalAire, Berlin Chemie-Menarini, Pfizer, MSD, Ascensia, and Amgen and has consulted for Abbott Diabetes Care, Roche, Medtronic, Berlin Chemie-Menarini and EvivaMed. SG has volunteered for the German Diabetes Society (Deutsche Diabetes Gesellschaft) and Diabetology Working Group Baden-Württemberg (Arbeitsgemeinschaft Diabetologie Baden-Württemberg). SB is a member of the advisory board of Amgen, Novartis, Sanofi, Novo Nordisk, and Daiichi Sankyo and has received speaker’s honoraria from Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Novartis, Novo Nordisk, and Sanofi. PB has received research funding and honoraria for consultancy from a number of companies including AstraZeneca, Bayer, Boehringer, Roche, and Sanofi., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: Reliable estimation of the time spent in different glycaemic ranges (time-in-ranges) requires sufficiently long continuous glucose monitoring. In a 2019 paper (Battelino et al., Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care. 2019;42:1593-1603), an international panel of experts suggested using a correlation-based approach to obtain the minimum number of days for reliable time-in-ranges estimates. More recently (in Camerlingo et al., Design of clinical trials to assess diabetes treatment: minimum duration of continuous glucose monitoring data to estimate time-in-ranges with the desired precision. Diabetes Obes Metab. 2021;23:2446-2454) we presented a mathematical equation linking the number of monitoring days to the uncertainty around time-in-ranges estimates. In this work, we compare these two approaches, mainly focusing on time spent in (70-180) mg/dL range (TIR)., Methods: The first 100 and 150 days of data were extracted from study A (148 subjects, ~180 days), and the first 100, 150, 200, 250 and 300 days of data from study B (45 subjects, ~365 days). For each of these data windows, the minimum monitoring duration was computed using correlation-based and equation-based approaches. The suggestions were compared for the windows of different durations extracted from the same study, and for the windows of equal duration extracted from different studies., Results: When changing the dataset duration, the correlation-based approach produces inconsistent results, ranging from 23 to 64 days, for TIR. The equation-based approach was found to be robust versus this issue, as it is affected only by the characteristics of the population being monitored. Indeed, to grant a confidence interval of 5% around TIR, it suggests 18 days for windows from study A, and 17 days for windows from study B. Similar considerations hold for other time-in-ranges., Conclusions: The equation-based approach offers advantages for the design of clinical trials having time-in-ranges as final end points, with focus on trial duration., (© 2021 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Aims: To investigate the seroconversion following first and second COVID-19 vaccination in people with type 1 and type 2 diabetes in relation to glycaemic control prior to vaccination and to analyse the response in comparison to individuals without diabetes., Materials and Methods: This prospective, multicentre cohort study analysed people with type 1 and type 2 diabetes and a glycated haemoglobin level ≤58 mmol/mol (7.5%) or >58 mmol/mol (7.5%), respectively, and healthy controls. Roche's Elecsys anti-SARS-CoV-2 S immunoassay targeting the receptor-binding domain was used to quantify anti-spike protein antibodies 7 to 14 days after the first and 14 to 21 days after the second vaccination., Results: A total of 86 healthy controls were enrolled in the study, as well as 161 participants with diabetes, of whom 150 (75 with type 1 diabetes and 75 with type 2 diabetes) were eligible for the analysis. After the first vaccination, only 52.7% of participants in the type 1 diabetes group and 48.0% of those in the type 2 diabetes group showed antibody levels above the cut-off for positivity. Antibody levels after the second vaccination were similar in participants with type 1 diabetes, participants with type 2 diabetes and healthy controls after adjusting for age, sex and multiple testing (P > 0.05). Age (r = -0.45, P < 0.001) and glomerular filtration rate (r = 0.28, P = 0.001) were significantly associated with antibody response., Conclusions: Anti-SARS-CoV-2 S receptor-binding domain antibody levels after the second vaccination were comparable in healthy controls and in participants with type 1 and type 2 diabetes, irrespective of glycaemic control. Age and renal function correlated significantly with the extent of antibody levels., (© 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Introduction: Drug errors pose a major health hazard to a number of patient populations. However, patients with type 2 diabetes mellitus seem especially vulnerable to this risk as diabetes mellitus is usually concomitant with various comorbidities and polypharmacy, which present significant risk factors for the occurrence of drug errors. Despite this fact, there is little data on drug errors from patients' perspective. The present survey aimed to examine the viewpoints of patients with type 2 diabetes mellitus regarding their experiences with medication errors, the overall treatment satisfaction, and their perceptions on how a medication error was handled in daily hospital routine., Materials and Methods: Inpatients at the Department of Endocrinology and Diabetology of the University Hospital of Graz were included in the survey. Out of 100 patients, one-half had insulin therapy before hospitalization while the other half had no insulin therapy prior to admission. After giving informed consent, patients filled out a questionnaire with 22 items., Results: Independent of their preexisting therapy, 25% of patients already suffered at least one drug error, whereby prescribing a wrong dose seemed to be the most common type of error. Furthermore, 26% of patients in the non-insulin versus 50% in the insulin group (p = 0.084) were convinced that drug errors were addressed honestly by the medical staff, while 54% in the non-insulin versus 80% in the insulin-group (p = 0.061) assumed that adequate measures were taken to prevent drug errors. Finally, 9 out of 10 patients seemed satisfied with their treatment regardless of their diabetes therapy., Discussion/conclusion: The results of the survey clearly showed that patients experienced at least one medication error during hospitalization. However, these errors only rarely led to patient harm. The survey also revealed the value of an honest and respectful doctor-patient relationship regarding patient perception of medication errors and general complaints. Increasing patient awareness on the existing in-hospital error management systems could eliminate treatment-related concerns and create a climate of trust that is essential for effective treatment., Competing Interests: JKM is a member in the advisory board of Boehringer Ingelheim, Eli Lilly, Medtronic, Prediktor A/S, Roche Diabetes Care, Sanofi-Aventis and received speaker honoraria from Abbott Diabetes Care, AstraZeneca, Dexcom, Eli Lilly, MSD, NovoNordisk A/S, Roche Diabetes Care, Sanofi, Servier and Takeda. FA received speaker honoraria from Eli Lilly, Merck Sharp & Dome, Boehringer Ingelheim, AstraZeneca, Amgen. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The other authors do not have a conflict of interest to report.

Aims: To conduct a pooled analysis to assess the performance of intermittently scanned continuous glucose monitoring (isCGM) in association with the rate of change in sensor glucose in a cohort of children, adolescents, and adults with type 1 diabetes., Material and Methods: In this pooled analysis, isCGM system accuracy was assessed depending on the rate of change in sensor glucose. Clinical studies that have been investigating isCGM accuracy against blood glucose, accompanied with collection time points were included in this analysis. isCGM performance was assessed by means of median absolute relative difference (MedARD), Parkes error grid (PEG) and Bland-Altman plot analyses., Results: Twelve studies comprising 311 participants were included, with a total of 15 837 paired measurements. The overall MedARD (interquartile range) was 12.7% (5.9-23.5) and MedARD differed significantly based on the rate of change in glucose (P < 0.001). An absolute difference of -22 mg/dL (-1.2 mmol/L) (95% limits of agreement [LoA] 60 mg/dL (3.3 mmol/L), -103 mg/dL (-5.7 mmol/L)) was found when glucose was rapidly increasing (isCGM glucose minus reference blood glucose), while a -32 mg/dL (1.8 mmol/L) (95% LoA 116 mg/dL (6.4 mmol/L), -51 mg/dL (-2.8 mmol/L)) absolute difference was observed in periods of rapidly decreasing glucose., Conclusions: The performance of isCGM was good when compared to reference blood glucose measurements. The rate of change in glucose for both increasing and decreasing glucose levels diminished isCGM performance, showing lower accuracy during high rates of glucose change., (© 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Background: Older adults with type 1 diabetes have distinct characteristics that can make optimising glycaemic control challenging. We sought to test our hypothesis that hybrid closed-loop glucose control is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with type 1 diabetes., Methods: In an open-label, multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with type 1 diabetes using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX, CamDiab, Cambridge, UK) and SAP therapy in random order. Block randomisation by means of central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3·9 and 10·0 mmol/L. Analysis for the primary endpoint and adverse events was by intention-to-treat. The study has completed and is registered at ClinicalTrials.gov NCT04025762., Findings: 38 participants were enrolled. One participant withdrew during run-in because of difficulties with the study pump infusion sets. 37 participants (median [IQR] age 68 [63-70] years, mean [SD] baseline glycated haemoglobin [HbA 1c ]; 7·4% [0·9%]; 57 [10] mmol/mol) were randomly assigned between Sept 4, 2019, and Oct 2, 2020. The proportion of time with glucose between 3·9 and 10·0 mmol/L was significantly higher in the closed-loop group compared to the SAP group (79·9% [SD 7·9] vs 71·4% [13·2], difference 8·6 percentage points [95% CI 6·3 to 11·0]; p<0·0001). Two severe hypoglycaemia events occurred during the SAP period. There were two non-treatment related serious adverse events: cardiac arrest from pulmonary embolism associated with COVID-19 during the SAP period resulting in death, and a hospital presentation for parenteral hydrocortisone because of COVID-19 in a participant with adrenal insufficiency during the run-in period., Interpretation: Hybrid closed-loop insulin delivery is safe and achieves superior glycaemic control to SAP therapy in older adults with long duration of type 1 diabetes. Importantly this was achieved without increasing the risk of hypoglycaemia in this population with risk factors for severe hypoglycaemia. This suggests that hybrid closed-loop therapy is a clinically important treatment option for older adults with type 1 diabetes.

The aim of this study was to evaluate the accuracy and usability of a novel continuous glucose monitoring (CGM) system designed for needle-free insertion and reduced environmental impact. We assessed the sensor performance of two GlucoMen ® Day CGM systems worn simultaneously by eight participants with type 1 diabetes. Self-monitoring of blood glucose (SMBG) was performed regularly over 14 days at home. Participants underwent two standardized, 5-h meal challenges at the research center with frequent plasma glucose (PG) measurements using a laboratory reference (YSI) instrument. When comparing CGM to PG, the overall mean absolute relative difference (MARD) was 9.7 [2.6-14.6]%. The overall MARD for CGM vs. SMBG was 13.1 [3.5-18.6]%. The consensus error grid (CEG) analysis showed 98% of both CGM/PG and CGM/SMBG pairs in the clinically acceptable zones A and B. The analysis confirmed that GlucoMen ® Day CGM meets the clinical requirements for state-of-the-art CGM. In addition, the needle-free insertion technology is well tolerated by users and reduces medical waste compared to conventional CGM systems.

Background: The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear., Methods: In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level, <70 mg per deciliter). Safety was assessed., Results: A total of 74 participants underwent randomization. The mean (±SD) age of the participants was 5.6±1.6 years, and the baseline glycated hemoglobin level was 7.3±0.7%. The percentage of time with the glucose level in the target range was 8.7 percentage points (95% confidence interval [CI], 7.4 to 9.9) higher during the closed-loop period than during the control period (P<0.001). The mean adjusted difference (closed-loop minus control) in the percentage of time spent in a hyperglycemic state was -8.5 percentage points (95% CI, -9.9 to -7.1), the difference in the glycated hemoglobin level was -0.4 percentage points (95% CI, -0.5 to -0.3), and the difference in the mean sensor glucose level was -12.3 mg per deciliter (95% CI, -14.8 to -9.8) (P<0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P = 0.74). The median time spent in the closed-loop mode was 95% (interquartile range, 92 to 97) over the 16-week closed-loop period. One serious adverse event of severe hypoglycemia occurred during the closed-loop period. One serious adverse event that was deemed to be unrelated to treatment occurred., Conclusions: A hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT03784027.)., (Copyright © 2022 Massachusetts Medical Society.)

Introduction: Renal complications are both a marker of previous suboptimal glycaemic control and a major risk factor for cardiovascular disease in persons with type 1 diabetes (T1D). The aim of the study was to evaluate the prevalence of renal complications in persons with T1D in four geographical regions., Methods: Nationwide registry data from Austria/Germany, Sweden and the US were used to estimate the prevalence of renal complications from January 2016 until September 2018. Chronic kidney disease (CKD) and albuminuria in the study population and each registry were analysed by diabetes duration. Risk factors for renal complications were described by registry., Results: In the total cohort of 78.926 adults with T1D, mean age was 44.4 ± 18.43 years and mean diabetes duration was 21.6 ± 22 years. Mean estimated glomerular filtration rate (eGFR) was 94.0 ± 31.45 ml/min, 13.0% had microalbuminuria and 3.9% had macroalbuminuria. Mean age, diabetes duration, use of insulin pumps and continuous glucose monitoring, as well as presence of albuminuria, varied between registries. Albuminuria was present in approximately 10% of persons with diabetes duration < 20 years and impaired renal function (eGFR < 60 ml/min) was present in 17%. In persons with diabetes duration > 40 years, approximately one-third had albuminuria and 25% had impaired renal function., Conclusions: This analysis used three nationwide registries of persons with T1D. Despite recent use of more effective diabetes therapies, a substantial proportion of persons with T1D have renal complications at < 20 years after diagnosis. Efficient glucose-lowering and renal-protective strategies are needed in persons with T1D., (© 2021. The Author(s).)

Background: Is insulin initiation linked to increasing body mass index (BMI) in all patients with type-2-diabetes (T2D)? To determine distinct longitudinal patterns of BMI change over time. Materials and Methods: 5057 patients with T2D (55% males, median BMI [IQR]: 30.0 [26.9-33.3] kg/m 2 ) aged ≥40 years at diabetes diagnosis and with ≥2 years of follow-up after insulin initiation irrespective of previous or concurrent use of metformin/dipeptidyl peptidase-4-inhibitor from the multicenter prospective diabetes registry DPV were studied. To identify subgroups following a similar pattern of BMI change after insulin initiation, longitudinal group-based trajectory modeling was applied. Multinomial logistic regression was then used to analyze covariates associated with group membership. Results: Three heterogeneous groups with either relevant BMI increase (delta-BMI: +4.0 kg/m 2 after 2 years; 12% of patients); slight BMI increase (+0.4 kg/m 2 ; 80%); or BMI decrease (-3.2 kg/m 2 ; 8%) were identified. Patients with older age [OR (95% CI): 1.37 (1.11-1.69)] and obesity [2.05 (1.65-2.55)] before insulin start were more often in the BMI decreasing group, and less often in the BMI increasing class [0.80 (0.67-0.95); 0.82 (0.69-0.98)]. A worse HbA1c both at insulin start and during follow-up [1.90 (1.60-2.26); 1.17 (1.07-1.27)], a higher insulin dose [1.67 (1.33-2.10)], and severe hypoglycemic events [2.38 (1.60-3.53)] after insulin initiation were all linked with higher odds of belonging to the BMI increasing trajectory. Conclusions: Patient heterogeneity with respect to weight gain after initiation of insulin therapy in adult T2D was detected by an objective computer algorithm. Older people with obesity should not defer from insulin use due to fear of weight gain.

In diabetes management, the fraction of time spent with glucose concentration within the physiological range of [70-180] mg/dL, namely time in range (TIR) is often computed by clinicians to assess glycemic control using a continuous glucose monitoring sensor. However, a sufficiently long monitoring period is required to reliably estimate this index. A mathematical equation derived by our group provides the minimum trial duration granting a desired uncertainty around the estimated TIR. The equation involves two parameters, p r and α, related to the population under analysis, which should be set based on the clinician's experience. In this work, we evaluated the sensitivity of the formula to the parameters.Considering two independent datasets, we predicted the uncertainty of TIR estimate for a population, using the parameters of the formula estimated for a different population. We also stressed the robustness of the formula by testing wider ranges of parameters, thus assessing the impact of large errors in the parameters' estimates.Plausible errors on the α estimate impact very slightly on the prediction (relative discrepancy < 5%), thus we suggest using a fixed value for α independently on the population being analyzed. Instead, p r should be adjusted to the TIR expected in the population, considering that errors around 20% result in a relative discrepancy of ~10%.In conclusion, the proposed formula is sufficiently robust to parameters setting and can be used by investigators to determine a suitable duration of the study.

Aim: To compute the uncertainty of time-in-ranges, such as time in range (TIR), time in tight range (TITR), time below range (TBR) and time above range (TAR), to evaluate glucose control and to determine the minimum duration of a trial to achieve the desired precision., Materials and Methods: Four formulas for the aforementioned time-in-ranges were obtained by estimating the equation's parameters on a training set extracted from study A (226 subjects, ~180 days, 5-minute Dexcom G4 Platinum sensor). The formulas were then validated on the remaining data. We also illustrate how to adjust the parameters for sensors with different sampling rates. Finally, we used study B (45 subjects, ~365 days, 15-minute Abbott Freestyle Libre sensor) to further validate our results., Results: Our approach was effective in predicting the uncertainty when time-in-ranges are estimated using n days of continuous glucose monitoring (CGM), matching the variability observed in the data. As an example, monitoring a population with TIR = 70%, TITR = 50%, TBR = 5% and TAR = 25% for 30 days warrants a precision of ±3.50%, ±3.68%, ±1.33% and ±3.66%, respectively., Conclusions: The presented approach can be used to both compute the uncertainty of time-in-ranges and determine the minimum duration of a trial to achieve the desired precision. An online tool to facilitate its implementation is made freely available to the clinical investigator., (© 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

The main objective of diabetes control is to correct hyperglycaemia while avoiding hypoglycaemia, especially in insulin-treated patients. Fear of hypoglycaemia is a hurdle to effective correction of hyperglycaemia because it promotes under-dosing of insulin. Strategies to minimise hypoglycaemia include education and training for improved hypoglycaemia awareness and the development of technologies to allow their early detection and thus minimise their occurrence. Patients with impaired hypoglycaemia awareness would benefit the most from these technologies. The purpose of this systematic review is to review currently available or in-development technologies that support detection of hypoglycaemia or hypoglycaemia risk, and identify gaps in the research. Nanomaterial use in sensors is a promising strategy to increase the accuracy of continuous glucose monitoring devices for low glucose values. Hypoglycaemia is associated with changes on vital signs, so electrocardiogram and encephalogram could also be used to detect hypoglycaemia. Accuracy improvements through multivariable measures can make already marketed galvanic skin response devices a good noninvasive alternative. Breath volatile organic compounds can be detected by dogs and devices and alert patients at hypoglycaemia onset, while near-infrared spectroscopy can also be used as a hypoglycaemia alarms. Finally, one of the main directions of research are deep learning algorithms to analyse continuous glucose monitoring data and provide earlier and more accurate prediction of hypoglycaemia. Current developments for early identification of hypoglycaemia risk combine improvements of available 'needle-type' enzymatic glucose sensors and noninvasive alternatives. Patient usability will be essential to demonstrate to allow their implementation for daily use in diabetes management., (© 2021 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd.)

Aim: To evaluate the efficacy and safety of basal-bolus insulin therapy in managing glycaemia during fasting periods in hospitalized patients with type 2 diabetes., Materials and Methods: We performed a post hoc analysis of two prospective, uncontrolled interventional trials that applied electronic decision support system-guided basal-bolus (meal-related and correction) insulin therapy. We searched for fasting periods (invasive or diagnostic procedures, medical condition) during inpatient stays. In a mixed model analysis, patients' glucose levels and insulin doses on days with regular food intake were compared with days with fasting periods., Results: Out of 249 patients, 115 patients (33.9% female, age 68.3 ± 10.3 years, diabetes duration 15.1 ± 10.9 years, body mass index 30.1 ± 5.4 kg/m 2 , HbA1c 69 ± 20 mmol/mol) had 194 days with fasting periods. Mean daily blood glucose (BG) was lower (modelled difference [ModDiff]: -0.5 ± 0.2 mmol/L, P = .006), and the proportion of glucose values within the target range (3.9-10.0 mmol/L) increased on days with fasting periods compared with days with regular food intake (ModDiff: +0.06 ± 0.02, P = .005). Glycaemic control on fasting days was driven by a reduction in daily bolus insulin doses (ModDiff: -11.0 ± 0.9 IU, P < .001), while basal insulin was similar (ModDiff: -1.1 ± 0.6 IU, P = .082) compared with non-fasting days. Regarding hypoglycaemic events (BG < 3.9 mmol/L), there was no difference between fasting and non-fasting days (χ 2 0.9% vs. 1.7%, P = .174)., Conclusions: When using well-titrated basal-bolus insulin therapy in hospitalized patients with type 2 diabetes, the basal insulin dose does not require adjustment during fasting periods to achieve safe glycaemic control, provided meal-related bolus insulin is omitted and correction bolus insulin is tailored to glucose levels., (© 2021 John Wiley & Sons Ltd.)

Background: Type 1 diabetes in young children is a heavy parental burden. As part of pilot phase of the KIDSAP01 study, we conducted a baseline assessment in parents to study the association between hypoglycemia fear, parental well-being and child behavior., Methods: All parents were invited to fill in baseline questionnaires: hypoglycemia fear survey (HFS), WHO-5, Epworth Sleepiness Scale and Strength and Difficulties Questionnaire (SDQ)., Results: 24 children (median age: 5-year, range 1-7 years, 63% male, mean diabetes duration: 3 ± 1.7 years) participated. 23/24 parents filled out the questionnaires. We found a higher score for the hypoglycemia fear behavior 33.9 ± 5.6 compared to hypoglycemia worry 34.6 ± 12.2. Median WHO-5 score was 16 (8 - 22) with poor well-being in two parents. Median daytime sleepiness score was high in five parents (>10). For six children a high total behavioral difficulty score (>16) was reported. Pro social behavior score was lower than normal in six children (<6). Parental well-being was negatively associated with HFS total ( r = - 0.50, p <.05) and subscale scores ( r = - 0.44, p <.05 for HFS-Worry and HFS-Behavior), child behavior ( r = - 0.45, p = .05) and positively with child age and diabetes duration ( r = 0.58, p <.01, r = 0.6, p <.01). HFS, parental well-being nor daytime sleepiness are associated with the HbA1c., Conclusion: Regular screening of parental well-being, hypoglycemia fear and child behavior should be part of routine care to target early intervention., Competing Interests: MT reports having received speaker honoraria from Minimed Medtronic and Novo Nordisk. MFr has received speaker honoraria from Minimed Medtronic and has served on advisory boards for Eli Lilly. JM is a member in the advisory board of Becton-Dickinson, Boehringer Ingelheim, Eli Lilly, Medtronic and Sanofi, and has received speaker honoraria from ABBOTT Diabetes Care, Astra Zeneca, Eli Lilly, Nintamed, Novo Nordisk, Roche Diabetes Care, Sanofi, Servier and Takeda. MW has received license fees from Becton Dickinson and has served as a consultant to Beckton Dickinson. SH declares speaker honoraria from Eli Lilly and Sanofi. EF-R reports having received speaker honoraria from Minimed Medtronic and Eli Lilly, serving on advisory boards for Eli Lilly. TK has received speaker honoraria from Minimed Medtronic, Roche and Eli Lilly and is member of an advisory board for ABBOTTt Diabetes Care. CdB has received speaker honoraria from Minimed Medtronic and is member of their European Psychology Advisory Board. FC does attend Advisory Boards and obtain speaking fees for ABBOTTt, Medtronic, Lilly, and NovoNordisk. BR-M reports having received speaker honoraria from Minimed Medtronic, Eli Lilly, Roche, Menarini and Novo Nordisk, serving on advisory boards for Eli Lilly. RH reports having received speaker honoraria from Eli Lilly, Dexcom and Novo Nordisk, receiving license fees from Medtronic, and being director at CamDiab. The remaining 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 © 2021 de Beaufort, Pit-ten Cate, Schierloh, Cohen, Boughton, Tauschmann, Allen, Nagl, Fritsch, Yong, Metcalfe, Schaeffer, Fichelle, Thiele, Abt, Faninger, Mader, Slegtenhorst, Ashcroft, Wilinska, Sibayan, Kollman, Hofer, Fröhlich-Reiterer, Kapellen, Acerini, Campbell, Rami-Merhar and Hovorka.)

Aims: To analyse time-trends in BMI, obesity and cardiometabolic risk in adults with type 1 diabetes (T1DM) from the Diabetes Prospective Follow-up registry DPV., Methods: Data from 62,519 individuals with T1DM (age ≥ 18 years, BMI ≥ 18.5 kg/m 2 ) were analysed. Multivariable regression models were used to determine time-trends in BMI, obesity and cardiometabolic risk and to identify predictors for increasing BMI. Results were compared to the NCD Risk Factor Collaboration (NCD-RisC) data for Germany., Results: Between 1999 and 2018 mean BMI increased from 25.0 kg/m 2 to 26.2 kg/m 2 in individuals with T1DM. This trend was most pronounced in young and middle-aged individuals (>21-55 years of age) and in those with higher baseline BMI. Insulin dose and diabetes duration were associated with increasing BMI. Between 1999 and 2016, the prevalence of obesity increased 1.8-fold in individuals with T1DM and 1.4-fold among the German population, respectively (NCD-RisC). Approximately 50-70% of individuals with obesity were insufficiently treated for hypertension and/or dyslipidaemia., Conclusion: In adults with T1DM the prevalence of obesity is increasing at a faster pace than in the German population. BMI needs to be closely monitored, particularly during young adulthood, and cardiovascular risk factors need to be controlled better to prevent CVD and premature death., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Aim: To evaluate the use of hybrid closed-loop glucose control with faster-acting insulin aspart (Fiasp) in adults with type 1 diabetes (T1D)., Research Design and Methods: In a double-blind, multinational, randomized, crossover study, 25 adults with T1D using insulin pump therapy (mean ± SD, age 38 ± 9 years, HbA1c 7.4% ± 0.8% [57 ± 8 mmol/mol]) underwent two 8-week periods of unrestricted living comparing hybrid closed-loop with Fiasp and hybrid closed-loop with standard insulin aspart in random order. During both interventions the CamAPS FX closed-loop system incorporating the Cambridge model predictive control algorithm was used., Results: In an intention-to-treat analysis, the proportion of time sensor glucose was in the target range (3.9-10.0 mmol/L; primary endpoint) was not different between interventions (75% ± 8% vs. 75% ± 8% for hybrid closed-loop with Fiasp vs. hybrid closed-loop with standard insulin aspart; mean-adjusted difference -0.6% [95% CI -1.8% to 0.7%]; p < .001 for non-inferiority [non-inferiority margin 5%]). The proportion of time with sensor glucose less than 3.9 mmol/L (median [IQR] 2.4% [1.2%-3.2%] vs. 2.9% [1.7%-4.0%]; p = .01) and less than 3.0 mmol/L (median [IQR] 0.4% [0.2%-0.7%] vs. 0.7% [0.2%-0.9%]; p = .03) was reduced with Fiasp versus standard insulin aspart. There was no difference in mean glucose (8.1 ± 0.8 vs. 8.0 ± 0.8 mmol/L; p = .13) or glucose variability (SD of sensor glucose 2.9 ± 0.5 vs. 2.9 ± 0.5 mmol/L; p = .90). Total daily insulin requirements did not differ (49 ± 15 vs. 49 ± 15 units/day; p = .45). No severe hypoglycaemia or ketoacidosis occurred., Conclusions: The use of Fiasp in the CamAPS FX closed-loop system may reduce hypoglycaemia without compromising glucose control compared with standard insulin aspart in adults with T1D., (© 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Maintaining good glycaemic control with the same infusion set for longer than 3 days may improve the quality of life of insulin pump users. The aim of the current study was to assess the efficacy and safety of the novel, extended-wear infusion set over 7 days of wear in adults with type 1 diabetes. Sixteen participants completed three identical 8-hour euglycaemic clamp experiments on Days 1, 4 and 7 of infusion set wear. Between the experiments, the participants were discharged home for routine diabetes management while wearing the same extended-wear infusion set throughout the study. Time to reach the maximum glucose infusion rate (T GIRmax ) on Day 7 was reduced by 67% compared with Day 1 (p < .001). The corresponding area under the glucose infusion rate curve (AUC GIR ) was comparable for the first 2 h of the clamp (p = .891) but decreased by 28% over time (p < .008). While the extent of insulin absorption decreased with prolonged wear, it was accompanied by an increase in insulin absorption rate. The infusion set survival rate was 100% without leakages, occlusion alarms, severe hypoglycaemia or ketoacidosis. The extended-wear infusion set proved safe and effective during prolonged wear in real-life conditions., (© 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Glucocorticoids represent frequently recommended and often indispensable immunosuppressant and anti-inflammatory agents prescribed in various medical conditions. Despite their proven efficacy, glucocorticoids bear a wide variety of side effects among which steroid induced hyperglycaemia (SIHG) is among the most important ones. SIHG, potentially causes new-onset hyperglycaemia or exacerbation of glucose control in patients with previously known diabetes. Retrospective data showed that similar to general hyperglycaemia in diabetes, SIHG in the hospital and in outpatient settings detrimentally impacts patient outcomes, including mortality. However, recommendations for treatment targets and guidelines for in-hospital as well as outpatient therapeutic management are lacking, partially due to missing evidence from clinical studies. Still, SIHG caused by various types of glucocorticoids is a common challenge in daily routine and clinical guidance is needed. In this review, we aimed to summarize clinical evidence of SIHG in inpatient care impacting clinical outcome, establishment of diagnosis, diagnostic procedures and therapeutic recommendations.

Background: The lipid-lowering and positive cardiovascular effect of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors was shown in several studies, hence, they are more widely used in the lipid-lowering management of individuals with high cardiovascular risk. As real-world data are still scarce, specifically in patients with type 2 diabetes (T2D), the aim of this retrospective analysis was to investigate the efficacy of PCSK9 inhibitors in lowering low-density lipoprotein cholesterol (LDL-C) in an outpatient clinic of a tertiary care center in routine care., Methods: A retrospective analysis of data extracted from the electronic patient record was performed. Patients who were routinely prescribed with PCSK9 inhibitor therapy (alirocumab or evolocumab) during the years 2016 and 2019 were included in the analysis. Characteristics of the patient population, the effects on LDL-C and HbA1c levels as well as subsequent cardiovascular events were assessed over an observation period of 18 months., Results: We identified 237 patients treated with PCSK9 inhibitors between January 2016 and September 2019. Almost all patients (97.5%) received PCSK9 inhibitors for secondary prevention. 26.2% of the population had a concomitant diabetes diagnosis. Intolerance to statins (83.1%), ezetimibe (44.7%) or both agents (42.6%) was reported frequently. Three months after initiation of PCSK9 inhibitor therapy, 61.2% of the patients achieved LDL-C levels < 70 mg/dl, and 44.1% LDL-C levels < 55 mg/dl. The median LDL-C was lowered from 141 mg/dl at baseline, to 60 mg/dl after 3 months and 66 mg/dl after 12 months indicating a reduction of LDL-C as follows: 57.5% after 3 months and 53.6% after 12 months. After 3 months of observation, target achievement of LDL-C was higher in patients with T2D compared to non-diabetes patients; < 55 mg/dl: 51% vs. 41.5%; < 70 mg/dl 69.4 vs. 58.5%. After 12 months even more pronounced target LDL achievement in T2D was demonstrated < 55 mg/dl: 58.8% vs. 30.1%; < 70 mg/dl 70.6 vs. 49.6%. Patients with insufficiently controlled T2D (HbA1c > 54 mmol/mol) had a higher reduction in LDL-C but still were more likely to subsequent cardiovascular events., Conclusions: Significant reductions in LDL-C and a high percentage of patients achieving recommended treatment targets were observed. The percentage of patients with T2D meeting recommended LDL-C targets was higher than in those without T2D. Still some patients did not achieve LDL-C levels as recommended in current guidelines. Special attention to the characteristics of these patients is required in the future to enable achievement of treatment goals and avoid adverse cardiovascular outcomes.