Glycemic control during Ramadan fasting in adolescents and young adults with type 1 diabetes on MiniMed™ 780G advanced hybrid closed-loop system: A randomized controlled trial

Background: MiniMed (TM) 780G is the most advanced insulin pump system approved for the treatment of type 1 diabetes mellitus (T1DM). Hypoglycemic events are a serious complication associated with T1DM management during Ramadan fasting. Aim: This prospective study assessed the safety, effectiveness and optimization of advanced hybrid closed loop (AHCL) system on glycemic metrics and the level of hypoglycemia in T1DM patients who wished to fast Ramadan. Methods: Forty-two T1DM patients (mean age 15.2 +/- 3.4 years) using AHCL system were divided into two groups (each n = 21): intervention group who adjusted AHCL settings and control group who kept the same settings as before Ramadan. Results: The most aggressive system settings among control group consisting of a 100 mg/dL glucose target, active insulin time of 2 h and bolus increment, maintained exceptional glycemia with time in range reaching 82.0 +/- 10.2%, time above range > 180 mg/dL of 12.1 +/- 3.5% without an increase in hypoglycemia (time below range 3.0 +/- 0.3%). All of which were non-significant in comparison to the intervention group. Overall time spent in closed loop (SmartGuard) by users averaged 98.7 +/- 2.1% in Auto Mode and involved only 1.0 +/- 0.7 exits per week indicating confidence in the system's performance. There were no severe hypoglycemic or diabetic ketoacidosis events during the study. Conclusions: MiniMed (TM) 780G AHCL system assist in safe fasting with minimal user input and allows for achievement of recommended glycemic targets in people with T1DM during Ramadan fasting. The system demonstrated reduction in hypoglycemia exposure without compromising safety.

Automated summary

This study assessed the safety and effectiveness of the advanced hybrid closed loop system in patients with type 1 diabetes during Ramadan fasting. The results showed that the system can safely assist fasting and achieve recommended glycemic targets while reducing the risk of hypoglycemia.