Performance and patients' satisfaction with the A7+TouchCare insulin patch pump system: A randomized controlled non-inferiority study.

BACKGROUND: We assessed the performance and patient satisfaction of a new insulin patch pump, the A7+TouchCare (Medtrum), compared with the Omnipod system. METHODS: This multicenter, randomized, open-label, controlled study enrolled 100 adult patients with type 1 or type 2 diabetes mellitus (A1C ≥ 6.5% and ≤ 9.5%, i.e., 48 to 80 mmol/mol) who were assigned with the Omnipod or with the A7+TouchCare pump for 3 months. The primary study outcome was the glucose management indicator (GMI) calculated with continuous glucose monitoring (CGM). RESULTS: Premature withdrawals occurs respectively in 2 and 9 participants in the Omnipod and TouchCare groups. In the Per Protocol analysis, the difference in GMI between groups was 0.002% (95% confidence interval -0.251; 0.255). The non-inferiority was demonstrated since the difference between treatments did not overlap the pre-defined non-inferiority margin (0.4%). There was no significant difference in CGM parameters between groups. On average, patients in both groups were satisfied/very satisfied with the insulin pump system. Patients preferred Omnipod as an insulin management system and especially the patch delivery system but preferred the A7+TouchCare personal diabetes manager to control the system. CONCLUSIONS: This study showed that the A7+TouchCare insulin pump was as efficient as the Omnipod pump in terms of performance and satisfaction. CLINICAL TRAIL REGISTRATION: The study was registered in the ClinicalTrials.gov protocol register (NCT04223973).

Shortening of the QT interval is observed soon after sleeve gastrectomy in morbidly obese patients.

BACKGROUND: Morbidly obese patients have an increased risk of sudden cardiac death. It is well known that obesity prolongs the QT interval, which in turn may cause ventricular arrhythmia and sudden cardiac death. The objective of this study was to establish whether sleeve gastrectomy shortens the QT interval. METHODS: Twenty-eight consecutive patients underwent sleeve gastrectomy at our institution between September 2010 and March 2011 and were included in the study. The indications for bariatric surgery were in accordance with French national guidelines. For each patient, an electrocardiogram was recorded before and then 3 months after surgery. The corrected QT (QTc) was determined independently by two physicians. RESULTS: The mean body mass index was 45.27 ± 6.09 kg/m(2) before surgery and 38.32 ± 5.19 kg/m(2) 3 months after surgery. The mean weight loss over this period was 20.71 ± 7.57 kg. The QTc interval was 427 ± 18.6 ms (415.7 ± 12.06 in men and 428.4 ± 18.96 in women) prior to surgery and was significantly lower 3 months after surgery (398.6 ± 15.5 ms overall, 391.3 ± 7.63 in men, and 399.6 ± 16.02 in women). The QTc interval decreased in all individual patients (by an average of 28.5 ± 15.6 ms overall, 24.3 ± 8.38 in men, and 29 ± 16.23 in women). Weight loss and decreased QTc interval were not significantly correlated (p = 0.88). CONCLUSION: Sleeve gastrectomy in morbidly obese patients was associated with a significantly lower QTc interval 3 months after surgery. These findings imply that bariatric surgery might reduce the risk of sudden cardiac death in this patient population.