Efficacy of the Diabeloop closed‐loop system to improve glycaemic control in patients with type 1 diabetes exposed to gastronomic dinners or to sustained physical exercise

Abstract

Aims To compare closed‐loop (CL) and open‐loop (OL) systems for glycaemic control in patients with type 1 diabetes (T1D) exposed to real‐life challenging situations (gastronomic dinners or sustained physical exercise). Methods Thirty‐eight adult patients with T1D were included in a three‐armed randomized pilot trial (Diabeloop WP6.2 trial) comparing glucose control using a CL system with use of an OL device during two crossover 72‐hour periods in one of the three following situations: large (gastronomic) dinners; sustained and repeated bouts of physical exercise (with uncontrolled food intake); or control (rest conditions). Outcomes included time in spent in the glucose ranges of 4.4‐7.8 mmol/L and 3.9‐10.0 mmol/L, and time in hypo‐ and hyperglycaemia. Results Time spent overnight in the tight range of 4.4 to 7.8 mmol/L was longer with CL (mean values: 63.2% vs 40.9% with OL; P ≤ .0001). Time spent during the day in the range of 3.9 to 10.0 mmol/L was also longer with CL (79.4% vs 64.1% with OL; P ≤ .0001). Participants using the CL system spent less time during the day with hyperglycaemic excursions (glucose >10.0 mmol/L) compared to those using an OL system (17.9% vs 31.9%; P ≤ .0001), and the proportions of time spent during the day with hyperglycaemic excursions of those using the CL system in the gastronomic dinner and physical exercise subgroups were of similar magnitude to those in the control subgroup (18.1 ± 6.3%, 17.2 ± 8.1% and 18.4 ± 12.5%, respectively). Finally, times spent in hypoglycaemia were short and not significantly different among the groups. Conclusions The Diabeloop CL system is superior to OL devices in reducing hyperglycaemic excursions in patients with T1D exposed to gastronomic dinners, or exposed to physical exercise followed by uncontrolled food and carbohydrate intake.

Hybrid closed‐loop therapy: Where are we in 2021?

“…The Pivotal Omnipod Horizon™ Automated Glucose Control System clinical trials are currently underway and are due to be completed in December 2021 24 as well as the Insulin‐Only Bionic Pancreas (iLET) Pivotal Trial 25 . Another closed‐loop system currently in use in France is the Diabeloop system 26,27 . The DBLG1 algorithm developed by Diabeloop is hosted on a dedicated handset and acts as a user interface.…”

Patients with highly unstable type 1 diabetes eligible for islet transplantation can be managed with a closed‐loop insulin delivery system: A series of N‐of‐1 randomized controlled trials

“…30 This would require further explorations with behavioural research, psychoeducational strategies and brain MRI. 31,32 Compared with the standard Diabeloop DBLG1 system, 10,11 the DBLHU system allows a higher number of modifications to the command settings, which makes it adaptable to various metabolic phenotypes. While we anticipated that 2 weeks of appropriate adjustments would be required, we observed a therapeutic improvement within a few days, and the results obtained over the entire 4-week periods were as favourable as those obtained over the third and fourth weeks.…”

“…Therefore, we evaluated the efficacy of the closed-loop Diabeloop for highly unstable diabetes (DBLHU) system (a hybrid, single hormone insulin delivery system derived from the Diabeloop DBLG1 system) 10,11 in those patients compared with a standard, open-loop PLGS system (DBLHU-WP10 trial).…”

Current treatment options and challenges in patients with Type 1 diabetes: Pharmacological, technical advances and future perspectives

“…Diabeloop algorithm is also installed in a smartphone, and communicate with CGM and patch pump, CSII system without a catheter. In a randomized crossover trial, an increase of 9.2% of the time spent in the target was observed using this AP [122], and performances were evaluated also in more challenging situations as meals and physical exercise [123]. The Omnipod Horizon system [124] uses a patch pump and both its safety and efficacy were demonstrated in both adults and pediatric T1Ds even also in an outpatient setting [125,126].…”