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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

      Highlights

      • This is the first clinical trial assessing AHCL system inT1DM during Ramadan fasting.
      • AHCL system improved mean glucose values, glycemic variability and time in ranges.
      • MiniMed™ 780G allows patients to reach all the international targets for T1DM during fasting without compromising safety.
      • Confidence in the system’s performance demonstrated by the high use of the sensor and AHCL Auto Mode seen suggests a promising level of acceptance.
      • AHCL assist in safe fasting with minimal user input not as the current recommendations for open loop insulin pumps.

      Abstract

      Background

      MiniMedTM 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™ 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.

      Keywords

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