Background and aims: Hypoglycemia represents a relevant burden in people with diabetes. Consequences of hypoglycemia/fear of hypoglycemia on quality of life (QoL) and behaviors of patients with T1DM and T2DM were assessed. Methods and results: HYPOS-1 was an observational retrospective study. Fear of hypoglycemia (Fear of Hypoglycemia Questionnaire, FHQ), general health status (visual analog scale of EuroQol questionnaire, EQ5D-VAS) psychological well-being (WHO-5 well being index, WHO-5), diabetes related distress (Problem Areas in Diabetes 5, PAID-5), and corrective/preventive behaviors following hypoglycemia were compared between people with and without previous experience of severe and symptomatic hypoglycemia and by tertiles of FHQ scores. A multivariate analysis was performed to identify factors associated with the likelihood of being in the third tertile of FHQ score. Overall, 2229 patients were involved. Severe hypoglycemia had statistically significant and clinically relevant (measured as effect sizes) negative impact on EQ5D-VAS, WHO-5, PAID-5, and FHQ both in T1DM and T2DM. In T2DM, symptomatic episodes had similar impact of severe hypoglycemia. Moving from the first to the third FHQ tertile, lower scores of EQ-5D VAS and WHO-5, and higher levels of PAID-5 were found. Patients in the third tertile performed more frequently corrective/preventive actions that negatively impact on metabolic control. Previous hypoglycemia, insulin treatment, female gender, age, and school education were the independent factors associated with increased likelihood to be in the third tertile. Conclusion: Not only severe but also symptomatic hypoglycemia negatively affect patient QoL, especially in T2DM. Addressing fear of hypoglycemia should be a goal of diabetes education. (C) 2019 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

There is an unmet need among healthcare providers to identify subgroups of patients with type 2 diabetes who are most likely to respond to treatment.

The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice.

Objective: Insulin injection aspects, such as fear of injection and pain, directly affect glycemic control, patient adherence and quality of life. Use of thinner and shorter needles could increase acceptance of injections. The aim of the study is to evaluate the non-inferiority of the new 34G x 3.5 mm needle compared to a 32G x 4 mm in patients with diabetes treated with insulin. Methods: This is an open, randomized, two-period crossover, non-inferiority trial. Every treatment period lasted 3 weeks. Patients with type 1 or type 2 diabetes, treated with multiple daily insulin injections, were randomly assigned to receive a 34G x 3.5 mm or a 32G x 4 mm pen needle. The primary endpoint was the non-inferiority of the 34G x 3.5 mm in comparison with the 32G x 4 mm pen needle in terms of percentage absolute change of blood fructosamine (% vertical bar Delta Fru vertical bar), using a non-inferiority margin of 20%. Results: Overall 77 patients were randomized and 73 completed the study. Patients characteristics were: 52% male, 80.5% affected by type 1 diabetes, mean age 52 years (+/- 14.6), mean BMI 24.5 kg/m(2) (+/- 5.6), HbA1c 8% (+/- 1.1) and baseline fructosamine level 350 mu mol/l (+/- 84). Mean fructosamine levels increased by 0.56 mu mol/l with the 34G needle, while a reduction of 7.29 mu mol/l was documented with the 32G needle. The difference between the two groups (7.84 mu mol/l) was not statistically significant (p= .27). The % vertical bar Delta Fru vertical bar between the two groups was 7.55% (95% CI 5.67-9.44), meeting the non-inferiority criterion. Glycemic variability, expressed as standard deviation of fasting blood glucose and postprandial glucose, was not different between the two treatment groups (p=.63 and p = .77, respectively). Conclusions: The 34G x 3.5 mm needle was non-inferior to the 32G x 4 mm needle regarding fructosamine levels and glycemic variability supporting the suitability of the 34G x 3.5 mm needle for insulin injection in patients with diabetes.

The ß-cell dysfunction of type 2 diabetes is partly reversible. The optimal time window to induce glycemic remission is uncertain; short courses of insulin treatment have been tested as a strategy to induce remission. In a pilot study in 38 newly-diagnosed patients, we assessed the time-course of insulin sensitivity and ß-cell function (by repeat oral glucose tolerance tests) following a 6-week basal insulin treatment compared to metformin monotherapy in equipoised glycemic control. At 6 weeks, insulin secretion and sensitivity were increased in both groups whilst ß-cell glucose sensitivity was unchanged. From this time onwards, in the insulin group glycemia started to rise at 3 months, and was no longer different from baseline at 1 year. The initial improvement in insulin secretion and sensitivity dissipated. In the metformin group, fasting plasma glucose and HbA1c levels reached a nadir at 8 months, at which time insulin secretion, glucose and insulin sensitivity were significantly better than at baseline and higher than in the insulin group. A short course of basal insulin in newly-diagnosed patients does not appear to offer clinical advantage over recommended initiation with metformin.

OBJECTIVES:Adherence to insulin therapy can be threatened by pain and needle fear. This cross-over randomized non-inferiority trial evaluated a new Pic Insupen 33G × 4 mm needle vs. a 32G × 4 mm needle in terms of metabolic control, safety and acceptability in patients with diabetes treated with insulin. RESEARCH DESIGN AND METHODS:We used a centralized, permuted block randomization, stratified by center and maximum insulin dose per single injection. Subjects used the two needles in two 3 week treatment periods. The primary endpoint was the absolute percentage variation of the blood fructosamine between the two treatments (% |ΔFru|). Additional endpoints were: glycemic variability, total insulin doses, body weight, severe hypoglycemic episodes, leakage at injection sites and pain measured by visual analogue scale. Equivalent glycemic control was defined a priori as % |ΔFru| (including 95% CI) within 20%. RESULTS:Of 87 subjects randomized, 77 completed the study (median age 53.1 [IR 42.3-61.2], median BMI 24.3 Kg/m(2) [IR 21.3-28.5], median duration of insulin therapy [in months] 141.4 (IR 56.3-256.9), median baseline HbA1c 7.9% [IR 7.2-8.8]). The % |ΔFru| was 7.93% (95% CI 6.23-9.63), meeting the non-inferiority criterion. The fasting blood glucose standard deviation was 46.2 (mean 154.6) with the 33G needle and 42.8 (mean 157.3) with the 32G needle (p=0.42). Insulin daily dose and patients' weight did not show any statistically significant variation. We observed 95 episodes of symptomatic hypoglycemia with the 33G needle and 96 with the 32G needle. One episode of severe hypoglycemia was documented in the latter group. As for insulin leakage we observed 37.55 episodes per 100 patient-days with the 33G needle and 32.21 episodes per 100 patient-days with the 32G needle (p=0.31). Patients reported less pain with the 33G × 4 mm needle (p=0.05). STUDY LIMITATIONS:Study sample was mainly composed of adults with type 1 diabetes and study was not blinded. CONCLUSIONS:The 33G needle is not inferior to the 32G needle in terms of efficacy and safety, with reduced pain and no difference in insulin leakage. CLINICAL TRIAL REGISTRATION:NCT01745549.

Diabet. Med. 28, 789–796 (2011)AbstractAims To estimate the efficacy of a self‐monitoring‐based disease management strategy in patients with Type 2 diabetes treated with oral agent monotherapy.Methods This was an open‐label, randomized, pilot study, primarily led by diabetes nurses. Patients were randomly allocated to either a self‐monitoring‐based disease management strategy or usual care (ratio 3:1) and followed up for 6 months. Education was centred on how to modify lifestyle according self‐monitoring readings. Self‐monitoring of blood glucose results were discussed during monthly telephone contact. The primary endpoint was mean change in HbA1c levels, estimated with an ANOVA for repeated measures. All analyses were intention to treat.Results Three diabetic clinics recruited 62 patients, of whom five were lost to follow‐up. At baseline, both groups had a mean HbA1c value of 7.9% ± 0.6% (63 ± 6 mmol/mol). After 6 months, mean HbA1c reduction was 1.2 ± 0.1% (–13 ± 1 mmol/mol) in the intervention group and 0.7 ± 0.2 (–8 ± 2 mmol/mol) in the control group, with an absolute mean difference between groups of –0.5% (95% CI −0.9 to −0.0%; P = 0.04) (−5 mmol/mol, 95% CI −10 to 0). At study end, 61.9% of patients in the intervention group and 20.0% in the control group reached the target level of HbA1c < 7.0% (< 53 mmol/mol) (P = 0.005). Body weight reduction was significantly greater in the intervention group than in the control group (between‐group absolute mean difference: −3.99 kg; 95% CI −7.26 to −0.73; P = 0.02). Therapy changes were more frequent in the control group.Conclusions A self‐monitoring disease management strategy, primarily led by diabetes nurses and allowing a timely and efficient use of self‐monitoring readings, is able to improve metabolic control, primarily through lifestyle modifications leading to weight loss.

Abstract Faglia E, Mantero M, Caminiti M, Caravaggi C, De Giglio R, Pritelli C, Clerici G, Fratino P, De Cata P, Paola LD, Mariani G, Poli M, Settembrini PG, Sciangula L, Morabito A, Graziani L (Internal Medicine Unit, Diabetology Centre, Policlinico Multimedica, Sesto San Giovanni, Milano; Centre for the Study and Treatment of Diabetic Foot Pathology, Abbiategrasso Hospital, Milano; Internal Medicine Unit, IRCCS Salvatore Maugeri Foundation, Pavia; Endocrinology and Metabolism Unit, Diabetic Foot Centre, Villa Berica Hospital, Vicenza Italy; Diabetology Centre and Vascular Surgery Division, S. Carlo Borromeo Hospital, Milano; Diabetology Centre, `Felice Villa' Hospital, Mariano Comense Como; Department of Medicine, Surgery and Dentistry, S. Paolo Hospital, University of Milan, Cardiovascular Catheterization Laboratory, `Città di Brescia' Hospital, Brescia, Italy). Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: clinical results of a multicentric study of 221 consecutive diabetic subjects. J Intern Med 2002; 252: 225–232.

1UO Malattie Metaboliche e Diabetologia, AO Treviglio (BG); 2Centro Ricerche EPIMED, Università degli Studi dell’Insubria (VA); 3UOS Diabete e Malattie Metaboliche, Ospedale San Gerardo, Monza; 4SSD Diabetologia ed Endocrinologia, Presidio Ospedaliero di Mariano Comense (CO); 5Centro Diabetologico Azienda Istituti Ospitalieri di Cremona; 6UOS Diabetologia, A. Ospedaliera Universitaria, Varese; 7UO Endocrinologia e CAD, Clinica Medica I, IRCCS Fondazione Policlinico San Matteo, Pavia; 8UO Diabetologia e Malattie Metaboliche, Ospedale di Desio (MB)