Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance.

AIM: To compare accuracy, efficacy and acceptance of implantable and transcutaneous continuous glucose monitoring (CGM) systems. METHODS: In a randomized crossover trial we compared 12 weeks with Eversense implantable sensor (EVS) and 12 weeks with Dexcom G5 transcutaneous sensor (DG5) in terms of accuracy, evaluated as Mean Absolute Relative Difference (MARD) vs capillary glucose (SMBG), time of CGM use, adverse events, efficacy (as HbA1c, time in range, time above and below range) and psychological outcomes evaluated with Diabetes Treatment Satisfaction Questionnaire (DTSQ), Glucose Monitoring Satisfaction Survey (GMSS), Hypoglycemia Fear Survey (HFS2), Diabetes Distress Scale (DDS). RESULTS: 16 subjects (13 males, 48.8 ± 10.1 years, HbA1c 55.8 ± 7.9 mmol/mol, mean ± SD) completed the study. DG5 was used more than EVS [percentage of use 95.7 ± 3.6% vs 93.5 ± 4.3% (p = 0.02)]. MARD was better with EVS (12.2 ± 11.5% vs. 13.1 ± 14.7%, p< 0.001). No differences were found in HbA1c. While using EVS time spent in range increased and time spent in hyperglycemia decreased, but these data were not confirmed by analysis of retrofitted data based on SMBG values. EVS reduced perceived distress, without significant changes in other psychological outcomes. CONCLUSIONS: CGM features may affect glycemic control and device acceptance.

FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions.

BACKGROUND AND AIMS: This study compared the accuracy of the FreeStyle Libre (Abbott, Alameda, CA) and Dexcom G4 Platinum (DG4P, Dexcom, San Diego, CA) CGM sensors. METHODS AND RESULTS: Twenty-two adults with type 1 diabetes wore the two sensors simultaneously for 2 weeks. Libre was used according to manufacturer-specified lifetime (MSL); DG4P was used 7 days beyond MSL. At a clinical research center (CRC), subjects were randomized to receive the same breakfast with standard insulin bolus (standard) or a delayed and increased (delayed & increased) bolus to induce large glucose swings during weeks 1 and 2; venous glucose was checked every 5-15 min for 6 h. Subjects performed ≥4 reference fingersticks/day at home. Accuracy was assessed by differences in mean absolute relative difference (%MARD) in glucose levels compared with fingerstick test (home use) and YSI reference (CRC). During home-stay the Libre MARD was 13.7 ± 3.6% and the DG4P MARD 12.9 ± 2.5% (difference not significant [NS]). With both systems MARD increased during hypoglycaemia and decreased during hyperglycaemia, without significant difference between sensors. In the euglycaemic range MARD was smaller with DG4P [12.0 ± 2.4% vs 14.0 ± 3.6%, p = 0.026]. MARD increased in both sensors following delayed & increased vs. standard bolus (Libre: 14.9 ± 5.5% vs. 10.9 ± 4.1%, p = 0.008; DG4P: 18.1 ± 8.1% vs. 13.1 ± 4.6%, p = 0.026); between-sensor differences were not significant (p = 0.062). Libre was more accurate during moderate and rapid glucose changes. CONCLUSIONS: DG4P and Libre performed similarly up to 7 days beyond DG4P MSL. Both sensors performed less well during hypoglycaemia but Libre was more accurate during glucose swings. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov (NCT02734745) April 12, 2016.

Gynecomastia in subjects with sexual dysfunction.

PURPOSE: To analyze possible relationships between gynecomastia and clinical and biochemical parameters in a large cohort of subjects with sexual dysfunction (SD). METHODS: A consecutive series of 4,023 men attending our Outpatient Clinic for SD was retrospectively studied. RESULTS: After excluding Klinefelter's syndrome patients, the prevalence of gynecomastia was 3.1 %. Subjects with gynecomastia had significantly lower testosterone (T) levels; the association retained statistical significance after adjusting for age and life-style. However, only 33.3 % of subjects with gynecomastia were hypogonadal. Gynecomastia was associated with delayed puberty, history of testicular or hepatic diseases, as well as cannabis abuse. Patients with gynecomastia more frequently reported sexual complaints, such as severe erectile dysfunction [odds ratio (OR) = 2.19 (1.26-3.86), p = 0.006], lower sexual desire and intercourse frequency [OR = 1.23 (1.06-1.58) and OR = 1.84 (1.22-2.78), respectively; both p < 0.05], orgasm difficulties [OR = 0.49 (0.28-0.83), p = 0.008], delayed ejaculation and lower ejaculate volume [OR = 1.89 (1.10-3.26) and OR = 1.51 (1.23-1.86), respectively; both p < 0.05]. Gynecomastia was also positively associated with severe obesity, lower testis volume and LH, and negatively with prostate-specific antigen levels. The further adjustment for T did not affect these results, except for obesity. After introducing body mass index as a further covariate, all the associations retained statistical significance, except for delayed ejaculation and ANDROTEST score. When considering gynecomastia severity, we found a step-wise, T-independent, decrease and increase of testis volume and LH, respectively. Gynecomastia was also associated with the use of several drugs in almost 40 % of our patients. CONCLUSION: Gynecomastia is a rare condition in subjects with SD, and could indicate a testosterone deficiency that deserves further investigation.