No more hypoglycaemia on days with physical activity and unrestricted diet when using a closed-loop system for 12 weeks: A post hoc secondary analysis of the multicentre, randomized controlled Diabeloop WP7 trial

Diabetes Obes Metab. 2021 Sep;23(9):2170-2176. doi: 10.1111/dom.14442. Epub 2021 Jun 3.

Abstract

A post hoc analysis of the Diabeloop WP7 multicentre, randomized controlled trial was performed to investigate the efficacy of the Diabeloop Generation-1 (DBLG1) closed-loop system in controlling the hypoglycaemia induced by physical activity (PA) in real-life conditions. Glycaemic outcomes were compared between days with and without PA in 56 patients with type 1 diabetes (T1D) using DBLG1 for 12 weeks. After the patient announces a PA, DBLG1 reduces insulin delivery and, if necessary, calculates the amount of preventive carbohydrates (CHO). Daily time spent in the interstitial glucose range less than 70 mg/dL was not significantly different between days with and without PA (2.0% ± 1.5% vs. 2.2% ± 1.1%), regardless of the intensity or duration of the PA. Preventive CHO intake recommended by the system was significantly higher in days with PA (41.1 ± 35.5 vs. 21.8 ± 28.5 g/day; P < .0001), and insulin delivery was significantly lower (31.5 ± 10.5 vs. 34.0 ± 10.5 U/day; P < .0001). The time spent in hyperglycaemia and the glycaemic variation coefficient increased significantly on days with PA. In real-life conditions, the use of DBLG1 avoids PA-induced hypoglycaemia. Insulin adjustments and preventive CHO recommendation may explain this therapeutic benefit.

Keywords: artificial pancreas; closed-loop system; continuous glucose monitoring; glycaemic control; hypoglycaemia; insulin pump therapy; physical activity; physical intervention; randomized controlled trial; type 1 diabetes.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Glucose
  • Cross-Over Studies
  • Diabetes Mellitus, Type 1* / drug therapy
  • Diet
  • Exercise
  • Humans
  • Hypoglycemia* / chemically induced
  • Hypoglycemia* / prevention & control
  • Hypoglycemic Agents / therapeutic use
  • Insulin / therapeutic use
  • Insulin Infusion Systems

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin