Effectiveness and Safety of the Intermittently Scanned Continuous Glucose Monitoring System FreeStyle Libre 2 in Patients with Type 2 Diabetes Treated with Basal Insulin or Oral Antidiabetic Drugs: An Observational, Retrospective Real-World Study.

Intermittently Scanned Continuous Glucose Monitoring (isCGM) devices are increasingly being used in patients with type 2 diabetes mellitus (T2DM) on insulin therapy for their benefits regarding disease management. Evidence of isCGM use in patients with T2DM on basal or non-insulin therapy is lacking. This study aimed at assessing the efficacy and safety of isCGM in this population. This was an observational, retrospective, real-world study enrolling patients with T2DM who were starting the use of isCGM. Data from medical records (i.e., demographics, clinical characteristics, laboratory assessments, and isCGM metrics) were collected over three time periods (baseline, 3 and 6 months). The endpoints were glycated haemoglobin (HbA1c) changes and changes in isCGM metrics as defined by the International Consensus from baseline to 3 months and 6 months. Overall, 132 patients were included (69.5% male; mean age 68.2 ± 11.0 years; mean disease duration 19.0 ± 9.4 years; 79.7% on basal insulin ±non-insulin therapy; mean baseline HbA1c 8.1% ± 1.3%). The estimated mean change in HbA1c was statistically significant at three (-0.4 ± 1.0%; p = 0.003) and six months (-0.6 ± 1.3%; p < 0.0001). In conclusion, isCGM proved to be effective and safe in improving glycaemic control in patients with T2DM on basal insulin or non-insulin therapy.

Combined Inositols, α-Lactalbumin, Gymnema Sylvestre and Zinc Improve the Lipid Metabolic Profile of Patients with Type 2 Diabetes Mellitus: A Randomized Clinical Trial.

Type 2 diabetes mellitus (T2DM) is characterized by high blood glucose levels and lipid alterations. Besides pharmacological treatment, lifestyle modifications and nutraceuticals can be used to manage glucose and lipid profiles, which is crucial for preventing, or avoiding, serious consequences associated with the condition. This randomized controlled clinical trial on 75 patients with T2DM evaluated the effects of a combination of myo-inositol and d-chiro-inositol (40:1), α-lactalbumin, Gymnema sylvestre, and zinc on glucose and lipid profile. The intention-to-treat analysis displayed no significant differences in glucose parameters between the groups; however, the study group displayed reduced levels of total cholesterol (p = 0.01) and LDL (p = 0.03) after 3 months of supplementation. A subgroup analysis involving patients who did not modify their antidiabetic therapy, after 6 months displayed improved levels of total cholesterol (p = 0.03) and LDL (p = 0.04) in the study group versus placebo, along with a greater body weight reduction (p = 0.03) after 3 months. Furthermore, within the study group, levels of HDL (p = 0.03) and triglycerides (p = 0.04) improved after 3 months. These findings support supplementation with myo-inositol and d-chiro-inositol (40:1), α-lactalbumin, Gymnema sylvestre, and zinc as an adjuvant and safe strategy to manage the lipid profiles of patients with T2DM.

The Effectiveness of Superbolus on Postprandial Blood Glucose Management of Pregnant Women With Type 1 Diabetes.

AIM: Pregnancies of women with pregestational diabetes are at risk of after-meal glucose peaks and late after-meal hypoglycemia, particularly at breakfast. We aimed to explore the effectiveness of a specific feature of insulin pump therapy called superbolus in preventing these glucose swings. METHODS: In this retrospective observational study, we analyzed continuous glucose monitoring data of patients with type 1 diabetes in pregnancy who were advised to use superbolus to manage their breakfast. Some of the postprandial basal insulin delivery was partially reduced and delivered instead as additional insulin bolus on top of a normal bolus. Outcomes of interest were one hour after breakfast glucose levels, the time in glucose range for after breakfast period, the number of late hypoglycemic episodes. RESULTS: Overall, 21 consecutive pregnant women with type 1 diabetes (mean age 34.3 ± 5.5 years, mean pregestational body mass index 23.7 ± 4.7 kg/m2, HbA1c levels during pregnancy 6.1 ± 0.6%) were studied. Superbolus reduced after breakfast glucose peaks (one hour after breakfast glucose levels 130 ± 17 mg/dL vs 123 ± 10 mg/dL before and after superbolus use, respectively, P = .01), improved the time in glucose range for after breakfast period (70.4% vs 50.8%, P = .001), and reduced the number of late hypoglycemic episodes (3 [1-5] vs 1 [0-2], P< .0001). CONCLUSION: Superbolus was effective in avoiding after-meal glucose peaks, increased postprandial glucose time in target, without late hypoglycemia occurrence. It represents a valid option for the treatment of pregnant women with type 1 diabetes using insulin pump.

The effectiveness of a televisit service for people with type 1 diabetes: An observational, retrospective, single center, one year follow-up study.

The use of a televisit service complying with efficiency and safety regulatory parameters was effective in significantly improving HbA1c levels of people with T1D after a one-year follow-up period. No acute diabetes-related complications occurred. Patients were highly satisfied with the service. Televisit is a valid option for diabetes management.

Minimed Medtronic 780G optimizes glucose control in patients with type 1 diabetes mellitus.

BACKGROUND AND AIMS: The new advanced hybrid closed loop insulin infusion systems have the potential to significantly improve glycaemic control. The aim of this study was to evaluate the effectiveness of the Minimed 780G system in 59 patients with type 1 diabetes. METHODS AND RESULTS: Glucose control obtained by using the system in automatic mode at 1-2 months of activation, at 2-4 months, at 4-6 months, and beyond 6 month was compared with those obtained with the system in manual mode. A significant improvement in time-in-range and in time-above-range throughout the follow-up was observed, as well as a significant reduction in time-below-range (<54 mg/dl) after 6 months, a significant reduction of the glucose variability and of HbA1c. After switching the mode, all target percentages lied on the average within the recommended ranges by literature consensus and no severe hypoglycemia nor ketoacidosis episodes were recorded. CONCLUSION: The Minimed 780G allowed a rapid and progressive improvement of the overall glucose control.

Teleconsultation in type 1 diabetes mellitus (TELEDIABE).

AIMS: The growing incidence of diabetes and the need to contain healthcare costs empower the necessity to identify new models of care. Telemedicine offers an acknowledged instrument to provide clinical health care at a distance, increasing patient compliance and the achievement of therapeutical goals. The objective was to test the feasibility and the efficacy in the improvement of the glycemic control of the teleconsultation for patients with type 1 diabetes mellitus. METHODS: A randomized open-label, parallel arms, controlled trial was conducted in two diabetes centers in Italy. Participants affected by type 1 diabetes mellitus have been randomly (1:1) assigned to receive their visits as standard or a web-based care. Patients in the teleconsultation group can arrange their appointments on a Web site and can also have access to web educational courses or to nutritional and psychological counseling. The primary outcome was the assessment of glycemic control by HbA1c measurement after a 12-month follow-up. RESULTS: Overall 74 participants were followed for 1 year. HbA1c changes were not statistically different within (p = 0.56 for standard care group; p = 0.45 for telemedicine group) and between (p = 0.60) groups when considering differences from baseline to the end of the study. Patients randomized to teleconsultation reported reduced severe hypoglycemic episodes (p = 0.03). In addition, they were largely satisfied with the activities, perceived a good improvement in the self-management of the diabetes, and reported to have a time saving and a cost reduction. CONCLUSIONS: In conclusion, TELEDIABE proposes a new system for the management of patients with type 1 diabetes mellitus.

GH treatment reduces trunkal adiposity in HIV-infected patients with lipodystrophy: a randomized placebo-controlled study.

OBJECTIVE: HIV lipodystrophy is a common complication of highly active anti-retroviral therapy, characterized by both metabolic and morphological features. The most feared morphological feature is body fat redistribution leading to HIV lipodystrophy. GH is known to induce reduction of visceral obesity and body fat redistribution in adults. DESIGN: A crossover, double-blind protocol of GH treatment (6 months of recombinant human GH (rhGH) at 0.2 IU/kg per week) vs placebo (6 months of placebo with a 2 month wash-out between periods) was performed. SUBJECTS AND SETTING: Thirty HIV-infected patients with lipodystrophy were recruited in the Outpatient Clinic of the Division of Infectious Diseases of San Raffaele Scientific Institute in Milan, Italy. MAIN OUTCOME AND RESULTS: Our data demonstrate an effect of low-dose rhGH administration in reducing trunk adiposity in HIV patients with lipodystrophy (Delta from basal: -394 +/- 814 g, P = 0.048 with respect to placebo. Data are given as mean +/- standard deviation). A trend to an increase of arm depots was also shown (Delta from basal: +43 +/- 384 g, P = NS with respect to placebo). Interestingly, no detrimental metabolic effects on glucose tolerance and lipid levels were found following the administration of 0.2 IU/kg per week of rhGH for 6 months. CONCLUSIONS: Low-dose GH administration is an effective treatment in reducing trunk obesity in HIV-infected patients with lipodystrophy.

Gender differences in antiretroviral drug-related adipose tissue alterations. Women are at higher risk than men and develop particular lipodystrophy patterns.

Adipose tissue alterations (ATAs) were clinically assessed in 2258 HIV-1-infected outpatients consecutively observed in 6 Italian clinical centers and were found to be present in 29.5% of the men and 41.9% of the women. A logistic regression model including age, HIV disease Centers for Disease Control stage, CD4 cell counts, HIV RNA load, the duration of antiretroviral therapy, the number of drugs taken, and the use of d4T showed that men had a 0.47 adjusted risk of presenting with ATAs (95% CI: 0.38-0.58, P < 0.0001). The risks of having ATAs (except circumscribed lipomas) in any body region, presenting with fat accumulation, or being affected by combined forms of ATA were also lower in men, whereas the risk of developing pure lipoatrophy was similar in the 2 genders. Our results indicate that women are at higher risk of developing antiretroviral treatment-related ATAs and show a particular and complex ATA pattern.

Stavudine or indinavir-containing regimens are associated with an increased risk of diabetes mellitus in HIV-infected individuals.

Diabetes mellitus was diagnosed in 16 out of 1011 HIV-positive patients over a median follow-up of 289 days (person-year incidence 2.06, 95% confidence interval 1.18-3.33). Significant risk factors for the onset of diabetes were older age and antiretroviral therapy with stavudine or indinavir. Older men with HIV infection should be considered at higher risk of diabetes, and caution maybe warranted in the use of both indinavir and stavudine in these patients.

Intramyocellular lipid accumulation and reduced whole body lipid oxidation in HIV lipodystrophy.

Antiretroviral therapy in human immunodeficiency virus (HIV)-positive patients can induce a lipodystrophy syndrome of peripheral fat wasting and central adiposity, dyslipidemia, and insulin resistance. To test whether in this syndrome insulin resistance is associated with abnormal muscle handling of fatty acids, 12 HIV-1 patients (8 females/4 males, age = 26 +/- 2 yr, HIV duration = 8 +/- 1 yr, body mass index = 22.0 +/- 1.0 kg/m(2), on protease inhibitors and nucleoside analog RT inhibitors) and 12 healthy subjects were studied. HIV-1 patients had a total body fat content (assessed by dual-energy X-ray absorptiometry) similar to that of controls (22 +/- 1 vs. 23 +/- 2%; P = 0.56), with a topographic fat redistribution characterized by reduced fat content in the legs (18 +/- 2 vs. 32 +/- 3%; P < 0.01) and increased fat content in the trunk (25 +/- 2 vs. 19 +/- 2%; P = 0.03). In HIV-positive patients, insulin sensitivity (assessed by QUICKI) was markedly impaired (0.341 +/- 0.011 vs. 0.376 +/- 0.007; P = 0.012). HIV-positive patients also had increased total plasma cholesterol (216 +/- 20 vs. 174 +/- 9 mg/dl; P = 0.05) and triglyceride (298 +/- 96 vs. 87 +/- 11 mg/dl; P = 0.03) concentrations. Muscular triglyceride content assessed by means of (1)H NMR spectroscopy was higher in HIV patients in soleus [92 +/- 12 vs. 42 +/- 5 arbitrary units (AU); P < 0.01] and tibialis anterior (26 +/- 6 vs. 11 +/- 3 AU; P = 0.04) muscles; in a stepwise regression analysis, it was strongly associated with QUICKI (R(2) = 0.27; P < 0.0093). Even if the basal metabolic rate (assessed by indirect calorimetry) was comparable to that of normal subjects, postabsorptive lipid oxidation was significantly impaired (0.30 +/- 0.07 vs. 0.88 +/- 0.09 mg x kg(-1) x min(-1); P < 0.01). In conclusion, lipodystrophy in HIV-1 patients in antiretroviral treatment is associated with intramuscular fat accumulation, which may mediate the development of the insulin resistance syndrome.

Normal insulin sensitivity and IMCL content in overweight humans are associated with higher fasting lipid oxidation.

Intramyocellular lipid (IMCL) storage is considered a local marker of whole body insulin resistance; because increments of body weight are supposed to impair insulin sensitivity, this study was designed to assess IMCL content, lipid oxidation, and insulin action in individuals with a moderate increment of body fat mass and no family history of diabetes. We studied 14 young, nonobese women with body fat <30% (n = 7) or >30% (n = 7) and 14 young, nonobese men with body fat <25% (n = 7) or >25% (n = 7) by means of the euglycemic-insulin clamp to assess whole body glucose metabolism, with indirect calorimetry to assess lipid oxidation, by localized (1)H NMR spectroscopy of the calf muscles to assess IMCL content, and with dual-energy X-ray absorptiometry to assess body composition. Subjects with higher body fat had normal insulin-stimulated glucose disposal (P = 0.80), IMCL content in both soleus (P = 0.22) and tibialis anterior (P = 0.75) muscles, and plasma free fatty acid levels (P = 0.075) compared with leaner subjects in association with increased lipid oxidation (P < 0.05), resting energy expenditure (P = 0.046), resting oxygen consumption (P = 0.049), and plasma leptin levels (P < 0.01) in the postabsorptive condition. In conclusion, in overweight subjects, preservation of insulin sensitivity was combined with increased lipid oxidation and maintenance of normal IMCL content, suggesting that abnormalities of these factors may mutually determine the development of insulin resistance associated with weight gain.