Lipohypertrophy (LH) is a major complication of subcutaneous insulin treatment brought about by multiple overlapping injections and/or needle reuse. It is responsible for unacceptable glucose oscillations due to a high rate of hypoglycaemic episodes and rebound glucose spikes. Skin ultrasound scans (USS), the gold standard for its detection, is too expensive for screening purposes. To define a structured method allowing health professionals (HPs) to identify LH lesions as inexpensively and correctly as possible. Out of 129 insulin-treated people with diabetes identified by USS as having LH lesions, only 40 agreed to participate in the study (24 females, age 54 ± 15 years, daily insulin dosage 57 ± 12 IU). Each was blindly examined by four well trained and four non-trained HPs according to a standard method involving repeated well codified maneuvers. A specific training allowed inexperienced HPs to acquire high diagnostic accuracy in identifying LH lesions independent of site, size, shape, and even BMI. This kind of training also allowed to reach a 97 % consistency rate among HPs as compared to USS, while the lack of training was associated with a wide variability and inconsistency of identification results. Diabetes teams should follow systematically the simple procedure reported in this paper for the diagnosis of LH and try to get it further implemented and progressively refined in large scale studies. This would have a major impact on patient education in terms of (1) correct injection technique and (2) ability to identify lesions early enough to prevent poor metabolic outcome.

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.

In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patient-centred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. In the context of the BENCH-D study, a set of instruments has been validated to measure patient well-being and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.

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 < 0.001), a much smaller decrease than seen for the IG (1.9%, p < 0.001). Only the IG presented significant decreases in HbA1c (8.2 ± 1.2% vs. 6.2 ± 0.9%; p < 0.01), GV (247 ± 61 mg/dl vs. 142 ± 31 mg/dl; p < 0.01), insulin requirement (− 20.7%, p < 0.001), and SeH and SyH prevalence (which dropped dramatically from 16.4 to 0.6% and from 83.7 to 7.6%, respectively; p < 0.001). In the IG group only, costs—including those due to the reduced insulin requirement—decreased significantly, especially those relating to SeHs and SyHs, which dropped to €25.8 and €602.5, respectively (p < 0.001). Conclusion Within a 6-month observation period, intensive structured education yielded consistently improved metabolic results and led to sharp decreases in the hypo rate and the insulin requirement. These improvements resulted in a parallel drop in overall healthcare costs, representing a tremendous economic advantage for the NHS. These positive results should encourage institutions to resolve the apparently intractable problem of LH by financially incentivizing healthcare teams to provide patients with intensive structured education on proper injection technique. Trial Registration Trial registration no. 118/15.04.2018, approved by the Scientific and Ethics Committee of Campania University “Luigi Vanvitelli,” Naples, Italy, and by the institutional review board (IRB Min. no. 9926 dated 05.05.2018).