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

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.

Meal and Physical Activity Detection from Free-Living Data for Discovering Disturbance Patterns of Glucose Levels in People with Diabetes

“…Commercially available AID systems are hybrid closed-loop systems, and they require these manual entries by the user. AID systems, also called artificial pancreas (AP), consist of a CGM, an insulin pump, and a closed-loop control algorithm that manipulates the insulin infusion rate delivered by the pump based on the recent CGM values reported [10][11][12][13][14][15][16][17][18][19][20][21][22][23]. More advanced AID systems that use a multivariable approach [10,[24][25][26] use additional inputs from wearable devices (such as wristbands) to automatically detect the occurrence of physical activity and incorporate this information to the automated control algorithms for a fully automated AID system [27].…”

Insight into continuous glucose monitoring: from medical basics to commercialized devices

“…Furthermore, the higher the patient's HbA1c, the more beneficial the use of CGMs is for the patient [118]. More recently, smart technologies using algorithms (artificial intelligence) were involved to be connected to CGMs and insulin pump in a closed-loop system allowing an automatic insulin administration by the pump driven by the algorithm [168][169][170].…”

“…The personal CGM has demonstrated to improves blood glucose monitoring, reduces day and nighttime hypoglycemia, prevents impending hypoglycemia and hyperglycemia and avoids severe hypoglycemia. Another new approach may improve diabetes management at the personal level: coupling a CGM with an insulin pump [20,[168][169][170]. A step towards such an artificial pancreas is achieved with these augmented sensor pumps (SAP), which can stop preventively the insulin infusion if the patient is at risk of hypoglycemia.…”

Automated Insulin Delivery (AID) Systems: Use and Efficacy in Children and Adults with Type 1 Diabetes and Other Forms of Diabetes in Europe in Early 2023

“…Data showed reduced glycemic excursions in patients treated with DBLG1 [ 47 ]. A post-hoc analysis RCT study confirmed no significant differences in time spent in hypoglycemia during days with and without physical activity [ 48 ].…”