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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 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.

The history of insulin-induced skin lipohypertrophy (LH) runs parallel to that of insulin's 100 years, and an average of 47% of insulin-treated patients still suffer from it today. The metabolic and economic effects of LH are significant, with hypoglycemia being the most striking. The objective of the study was to perform a 52-week follow-up of 713 insulin-treated patients with type 2 diabetes (T2DM) and LH to detect any differences in the occurrence of hypoglycemic events (HYPOs) and related healthcare costs as well as in LH rates and injection habits between an intensive education intervention group (IG) and control group (CG) provided with a single educational session at the starting point.All participants were trained in accurately self-monitoring blood glucose and recording all HYPOs for 6 months, which allowed baseline recordings before they were randomized into the IG, comprising 395 insulin-treated subjects undergoing repeated, structured multimodal education on correct injection techniques as a longstanding behavioral rehabilitation strategy, and the CG, comprising 318 subjects receiving the same structured, multimodal educational session, but only initially.Changes in LH rate and size and in performance were large in the IG and only slight and transient in the CG. A striking difference in the rate of decrease of HYPOs was also apparent between groups. Indeed, estimated costs of health interventions for severe and symptomatic HYPOs, which were on the order of €70,000 and €9300, respectively, in the two groups at baseline decreased by 5.9 times and 13.7 times, respectively, at the end of follow-up in the IG and by only approximately half in the CG. Full details of the changes occurring as a result of intensive education are provided in the text.The effect of only initial education in the CG was not significant, thus providing evidence of the virtual worthlessness of a single training session on injection techniques, typical of worldwide daily clinical practice, and easily explaining the extremely high prevalence of LH in insulin-treated patients. Conversely, highly positive effects on LH prevalence and size as well as costs expected from decreased HYPO rate were obtained in the IG. To our knowledge, ours is the first 18-month randomized trial in the field. If our experimental model were to be used as an effective, longstanding behavioral rehabilitation strategy and therefore adapted to real-world settings universally, LH prevalence and costs related to their clinical consequences would be drastically reduced. However, only with a strong, relentless commitment of universities, scientific societies, and patient associations can we achieve this ambitious goal, which would provide great institutional savings and improved quality of life for people with diabetes.

Background: Several outstanding pharmacological advances making innovative drugs sophisticateddevices available during the last few years. Nevertheless too many patients still disappointingly fail to meetthe metabolic targets suggested by current guidelines. Incorrect insulin administration techniques may greatly affect metabolic control in T2DM people. The aim of our study was to compare glycemic control associated with a concentrated insulin analog preparation (U-200 lispro) in people with T2DM to the one observed with standard U-100 lispro. The secondary endpoint of our study was patients’ preference and performance ratings of U-200 lispro. Methods: 126 patients with T2DM were enrolled. They were also assessed for limited joint mobility syndrome (LJMS),defined as limitation in at least two anatomical areas of the dominant upper extremity. After a 4-weekstructured insulin injection education period. Half of them were randomized to U-100 lispro, half to U-200 and after 12weeks they were switched to the other preparation for 12weeks. At the end a questionnaire was also administered to investigate patient preference. Results: No significant variation in fasting blood glucose, HbA1c, severe or mild hypoglycemic rate and daily fast-acting insulin analog dose was observed with U-100 lispro while U-200 lispro treatment was associated with a significant improvement of all the above mentioned parameters and with around 20% decrease in insulin requirement. Moreover patients’ answers to the questionnaire pointed out a higher preference for U-200 lispro for continuing treatment due to fewer difficulties completing injection. Discussion: The explanation of better metabolic results with the U-200 device might be the lower inner piston inertia and volume and shorter duration of a complete injection. Conclusions: Checking for LJIMS before insulin prescription could be adopted as a standard practiceaimed at choosing the most suitable device for patient's specific characteristics and abilities. The use of U-200 lispro might improve treatment adherence and metabolic control. This would also result intocost reduction by saving about half the amount of pens per year and of time spent to both fill prescriptionand dump the pharmacy.

Berberine, a quaternary isoquinoline alkaloid present in Berberis aristata, is well known in terms of its cholesterol-lowering, hypoglycemic, and insulinsensitizer effects. Because of its low oral bioavailability, it has been recently formulated along with silymarin (Silybum marianum) to improve intestinal absorption. The aim of our study was to evaluate, versus placebo treatment, the possible effect of its association with silymarin on abdominal fat in overweight/obese patients affected by type 2 diabetes mellitus. Using bioelectrical impedance at enrolment and after 6 months of treatment, we have evaluated the following clinical parameters: waist circumference, trunk fat, and visceral fat. Our results seem to indicate a clinically significant effect for the association berberine+silymarin.

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.

Full-text(opens in a new window)|Order document(opens in a new window)|View at Publisher| Export | Download | Add to List | More... Acta Diabetologica Volume 51, Issue 3, June 2014, Pages 447-453 Different prevalence of metabolic control and chronic complication rate according to the time of referral to a diabetes care unit in the elderly (Article) Strollo, F.a , Guarino, G.b, Marino, G.b, Paolisso, G.c, Gentile, S.b a Endocrine-Metabolic Unit, INRCA, Rome, Italy b Department of Clinical and Experimental Medicine, 2nd University of Naples, Naples, Italy c Department of Geriatrics and Metabolic Diseases, 2nd University of Naples, Naples, Italy View additional affiliations View references (35) Abstract The time of diagnosis is crucial for type 2 diabetes mellitus (T2DM) in terms of disease severity and chronic complications, as initial glycated haemoglobin (HbA1c) predicts 5-year cardiovascularmortality. The Italian health-care system relies on about 650 diabetes care units (DCU) interfacing with a large number of general practitioners (GPs). It may thus reach the goal of preventing complications easier than others by adopting a more comprehensive multifactorial approach. To assess whether the interval between diagnosis and referral to the DCU might influence the course of the disease in terms of HbA1c, associated cardiovascular risk factors, drug utilisation, and chronic complications in the elderly, the electronic records of 313 elderly T2DM patients (74.6 ± 4.9 years) followed by their GPs until referral to our DCU were retrospectively analysed for the above-mentioned parameters and divided into an early referral (ER) group (diagnosed within 12 months, n = 111) and a late referral (LR) group (diagnosed>12 months before, n = 202). A further set of 200 patients routinely taken care by our DCU, matched with the LR group for age, gender, and disease duration, was classified as "long-standing follow-up" (LSF) and compared to the others to rule out any confounding effects of long-standing disease per se on the clinical outcomes investigated in our study. About 35% of T2DM patients referred to our DCU within 12 months of diagnosis; the rest did so some 5 years after diagnosis. LR patients displayed worse HbA1c levels (10.8 vs. 7.7%, p < 0.01), used more drugs, and had more than twice as high complication rates as their ER counterparts. Almost all risk factors and complications were lower in the LSF (0.001 < p < 0.05) and ER groups than in the LR group. In both the ER and the LSF groups, we observed a lower burden of diabetes than in the LR group. This rules out the possibility that disease duration might play a major role per se in the burden of the disease in the elderly as opposed to the thoughtful patient care attitude exhibited by the DCU. A better and more efficient organisation has to be developed, including a strong interaction among GPs, diabetes specialists, and elderly people with T2DM allowing the latter to take charge of their own disease management through a sustained empowerment policy.