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Type 2 diabetes (T2DM) is known to be associated with increased cardiovascular (CV) morbidity and mortality. Over time, the CV Risk of patients with T2DM has been assessed according to various methods, often borrowed from different populations. Nevertheless, never have been evaluated changes in insulin absorption due to improper injection technique and responsible for further, well recognized CV-R factors as high glycemic variability, frequent hypoglycemia, and unsatisfactory glycemic control. Aim of the study was to intensify diabetes and its own comorbidities treatment, and in addition reduce the impact of injection technique of insulin to evaluate possible improvement in the CV-R score and NHYA score in 4499 insulin-treated T2DM subjects with (LH+) and without lipohypertrophy (LH-) due to improper injection habit. The educational training and the treatment intensification significantly reduced glycemic control, hypoglycemia rate and the mean amplitude of glycemic variability, expecially in LH+ subjects, adding new knowledge to a global intervention addressed to reduce the devastating impact to the increased cardiovascular risk of diabetic people, inclusive of the risk due to LHs

Introduction Studies on the durability of an intensive, structured education protocol on best insulin injection practice are missing for people with type 2 diabetes mellitus (T2DM). The aim of this study was to assess the durability of an intensive, structured education-based rehabilitation protocol on best insulin injection practice in well-trained subjects from our previous intensive, multimedia intervention study registered as the ISTERP-1 study. A total of 158 subjects with T2DM from the well-trained group of the 6-month-long ISTERP-1 study, all of whom had successfully attained lower glucose levels compared to baseline levels with lower daily insulin doses and with less frequent and severe hypoglycemic episodes, participated in the present investigation involving an additional 6-month follow-up period, called the ISTERP-2 study. Methods Participants were randomized into an intervention group and a control group, depending on whether they were provided or not provided with further education refresher courses for 6 months. At the end of the 6 months, the two groups were compared in terms of injection habits, daily insulin dose requirement, number of severe or symptomatic hypoglycemic events, and glycated hemoglobin (HbA1c) levels. Results Despite being virtually superimposable at baseline, the two groups behaved quite differently during the follow-up. The within-group analysis of observed parameters showed that the subjects in the intervention group maintained and even improved the good behavioral results learned during the ISTERP-1 study by further reducing both the rate of injection technique errors (p

Introduction It is essential to use the correct injection technique (IT) to avoid skin complications such as lipohypertrophy (LH), local inflammation, bruising, and consequent repeated unexplained hypoglycemia episodes (hypos) as well as high HbA1c (glycated hemoglobin) levels, glycemic variability (GV), and insulin doses. Structured education plays a prominent role in injection technique improvement. The aim was to assess the ability of structured education to reduce (i) GV and hypos, (ii) HbA1c levels, (iii) insulin daily doses, and (iv) overall healthcare-related costs in outpatients with T2DM who were erroneously injecting insulin into LH. Methods 318 patients aged 19–75 years who had been diagnosed with T2DM for at least 5 years, were being treated with insulin, were routinely followed by a private network of healthcare centers, and who had easily seen and palpable LH nodules were included in the study. At the beginning of the 6-month run-in period (T−6), all patients were trained to perform structured self-monitoring of blood glucose and to monitor symptomatic and severe hypos (SyHs and SeHs, respectively). After that (at T0), the patients were randomly and equally divided into an intervention group who received appropriate IT education (IG) and a control group (CG), and were followed up for six months (until T+6). Healthcare cost calculations (including resource utilization, loss of productivity, and more) were carried out based on the average NHS reimbursement price list. Results Baseline characteristics were the same for both groups. During follow-up, the intra-LH injection rate for the CG progressively decreased to 59.9% (p

Introduction Despite the availability of sophisticated devices and suitable recommendations on how to best perform insulin injections, lipohypertrophy (LH) and bruising (BR) frequently occur as a consequence of improper injection technique. Aim The purpose of this nationwide survey was to check literature-reported LH risk factors or consequences for any association with BR Method This was a cross-sectional, observational, multicenter study based on the identification of skin lesions at all patient-reported insulin injection sites in 790 subjects with diabetes. General and injection habit-related elements were investigated as possible BR risk factors. Results While confirming the close relationship existing between LH and a full series of factors including missed injection site rotation, needle reuse, long-standing insulin treatment, frequent hypoglycemic events (hypos), and great glycemic variability (GV), the observed data could find no such association with BR, which anyhow came with high HbA1c levels, missed injection site rotation, and long-standing insulin treatment. Conclusion BR most likely depends on the patient’s habit of pressing the injection pen hard onto the skin. Despite being worrisome and affecting quality of life, BR seems to represent a preliminary stage of LH but does not affect the rate of hypos and GV. Trial Registration 207/19.09.2017

Background Frail populations burdened with chronic diseases can get more severe forms of coronavirus disease-2019 (COVID-19) and have a higher mortality rate. Aim To test the efficacy of a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) containment protocol in patients with endstage renal disease (ESRD) diabetes mellitus (DM) requiring dialysis, who are a typical example of the above category. Methods The protocol included: (i) daily telephone COVID-19 related triage for patients and their general practitioners (GPs); (ii) social distancing; (iii) environment sanitization, including ambulances, transfer vans, medical equipment, patient/health personnel clothing, and individual protection devices; (iv) adoption of quota systems for patients allowed to the dialysis room, and increased time lags among dialysis shifts. Eight hundred twenty-five (825) patients on dialysis (315 with and 510 without DM), and 381 healthcare providers (HCPs) were monitored continuously from the start of the pandemic until the end of the lockdown. Results No HCPs were infected, while only two patients on dialysis were positive for SARS-CoV-2: one with DM, who died in intensive care, and one without DM, who recovered at home. The adopted contagion containment protocol proved to be effective for both HCPs and patients. Conclusion Therefore, we propose it as a useful model for any internal medicine or ESRD specialized units dealing with patients on dialysisoriented with or without DM.

Background After the official coronavirus (severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)) pandemic declaration by the World Health Organization (WHO), Italy had the second-largest number of confirmed cases, after China. The Italian government introduced progressive infection-mitigation measurements, thus dramatically reducing social interactions and preventing virus spread. During the summer, infection containment measures progressively loosened until, due to an unjustified interpretation of some permissions and the excessive utilization of public transportation at school reopening, the contagion rate progressively increased until causing a severe challenge for our National Health Service (NHS) again. Aim To assess the efficiency of our previously described protocol in 18 Campania region-located Nefrocenter Consortium dialysis centers (DCs) as further adapted to new knowledge under the new ubiquitous contagion conditions and to identify SARS-CoV-2-infection mortality rate and risk factors. Methods 381 HCP members underwent regular monitoring on April 1 and November 13, 2020. Dialysis patients did so too during that period according to the expected shifting prevalence over time (mean±SD:853±30 per month; range 825 to 873) vs (11.8% in April, and 14.8% in November vs. a pre-coronavirus disease-2019 (COVID-19) 12.0% rate in January). Results More patients got infected in November (10.19%) than in April (0,24%), and 22 patients of the 89 from the SARS-CoV-2 November positive subjects required hospitalization for moderate-severe symptoms (24.72%), with death unavoidably coming in 19 (86.36% of hospitalized and 21.35% of infected patients) compared to the only one recorded in April (0.12%). The pandemic’s two periods showed a strong association between mortality rate and often co-existing comorbidities, primarily represented by arterial hypertension, type 2 diabetes mellitus (T2DM), and chronic kidney disease (CKD). Conclusion The previously efficient contagion containment measures adopted by our DCs were not enough in November to fight the global infection risk pending on the whole Italian social community around. The author, discuss possible reasons and put forward further suggestions for the best handling of any future infection waves.

Background The number of older adults with insulin-treated diabetes mellitus (DM) is steadily increasing worldwide. Errors in the insulin injection technique can lead to skin lipohypertrophy (LH), which is the accumulation of fat cells and fibrin in the subcutaneous tissue. While lipohypertrophic lesions/nodules (LHs) due to incorrect insulin injection techniques are very common, they are often flat and hardly visible and thus require thorough deep palpation examination and ultrasonography (US) for detection. Detection is crucial because such lesions may eventually result in poor diabetes control due to their association with unpredictable insulin release patterns. Skin undergoes fundamental structural changes with aging, possibly increasing the risk for LH. We have therefore investigated the effect of age on the prevalence of LHs and on factors potentially associated with such lesions. Methods A total of 1227 insulin-treated outpatients with type 2 DM (T2DM) referred to our diabetes centers were consecutively enrolled in the study. These patients underwent a thorough clinical and US evaluation of the skin at injection sites, as previously described, with up to 95% concordance betweenthe clinical and US screening techniques. Of these 1227 patients, 718 (59%) had LH (LH+) and 509 (41%) were LH-free (LH−). These patients were then assigned to two age class groups (≤ 65 years and > 65 years), and several clinical features, diabetes complication rates, and injection habits were investigated. Results Comparison of the two age subgroups revealed that 396 (48%) and 322 (79%) patients in the younger and older groups, respectively, had LHs (p

Introduction Lipohypertrophies (LHs) due to incorrect insulin injection techniques have been described in the literature for decades. Their rate averages 38%, but this is still controversial because of the vast range reported by different publications, most of which fail to describe the selected detection protocol and therefore are not entirely reliable. We still need to identify the real LH rate, and only consistently using a standardized method in a large cohort of insulin-treated (IT) patients make this possible. Methods Our group performed thorough clinical skin examinations on patients suffering from type 2 diabetes mellitus (T2DM): 1247 IT T2DM outpatients were examined according to a standardized protocol, previously published elsewhere, as well as an ultrasound scan of the same skin areas to assess the degree of concordance between the two methods and to evaluate the demographic, clinical, and behavioral risk factors (RF) as well as metabolic consequences of identified LHs. Results The concordance between the two methods was 99%. Identified risk factors for LHs were needle reuse, failure to rotate injection sites, and ice-cold insulin injections. High HbA1c values, wide glycemic variability, and longstanding proneness to hypoglycemia with a high rate of ongoing hypoglycemic events proved to be significantly associated with LHs, too; the same applied to cardiovascular and renal complications as well as to living alone and being retired. Conclusions Based on a strict well-structured methodology, our data confirmed what has already been reported in the literature on factors leading to, or associated with, LHs and, for the first time in adults, indicated cryotrauma from ice-cold insulin injections and specific social conditions as factors facilitating LH occurrence. HCPs should therefore plan a yearly clinical examination of all injection sites to improve patient quality of life through better glucose control and a reduced rate of hypoglycemic events. Trial Registration Trial registration no. 127-11.01.2019, approved by the Scientific and Ethics Committee of Campania University “Luigi Vanvitelli,” Naples, Italy.

Background Diabetes mellitus (DM) is the leading cause of end-stage renal disease and 50% of dialysis patients are insulin-treated. Aim to search for unexplained hypoglycemia (HYPO). Methods identify a possible cause of HYPO due to altered insulin absorption. Results insulin injected into subcutaneous lipo-hypertrophy (LH) nodules leads to unpredictable HYPOS. Conclusion looking for LH systematically and training patients to the best injection technique are new challenges for nephrologists to reduce HYPO and emergency hospitalization rates, thus sparing healthcare resources and improving the quality of life of insulin-treated dialysis patients.

Introduction End-stage renal disease (ESRD) is associated with increased cardiovascular mortality (CVM) and diabetes mellitus (DM), which in many cases is treated with insulin. Skin lipohypertrophy (LH) very often occurs in insulin-treated (IT) patients as a consequence of inadequate injection technique and is one of the most prominent contributors to hypoglycemia (HYPO), glycemic variability (GV), and poor metabolic control (PMC). Method The aim of our multicenter observational study was to assess LH prevalence at self-injection sites and any possible factors predicting high LH/HYPO rates and GV in 296 dialyzed ITDM patients characterized by 64 ± 7 years of age, 7 ± 2 years disease duration, 2.6 ± 2.2 years dialysis duration, preferred pen utilization (80%), and basal-bolus regimen (87.4%) with self-injections (62.6%) largely surpassing caregiver-assisted ones (16.9%), and a mix of the two injection methods (20.5%). Results LH was detected in 57% of patients. Univariate analysis followed by backwards stepwise multivariate logistic regression function showed increased odds for developing LH in patients characterized by needle reuse, smaller injection areas, missed injection site rotation, higher HbA1c levels, and more prominent rates of HYPO and GV. Conclusion This was the first time such observation was made. It is now time for further studies aimed at providing evidence also in ESRD ITDM patients for the cause–effect relationship among wrong injection behavior, LH, and poor metabolic control and for the long-term preventative role of suitable educational countermeasures. Electronic supplementary material The online version of this article (10.1007/s13300-019-0650-2) contains supplementary material, which is available to authorized users.

Lipohypertophy (LH) is the most common skin complication of incorrect injection technique which does not only represent an aesthetic defect but also severely disrupts insulin pharmacokinetics/pharmacodynamics. As a consequence of that, hormone release is delayed and unexplained/unpredictable hypoglycemia occurs, both deteriorating metabolic control while negatively affecting adherence to treatment and quality of life. The economic burden due to unwanted intra-LH injections is accounted for by inappropriately high insulin requirements, increased emergency-related hospitalizations, and loss of work days. Greater attention has to be paid by diabetes care teams to education programs with periodic refreshers to achieve better metabolic control and reduce the economic burden of diabetes.