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Closed-loop driven by control-to-range algorithm outperforms threshold-low-glucose-suspend insulin delivery on
Eric Renard1,2,3, Nadia Tubiana-Rufi4, Elisabeth Bonnemaison-Gilbert5
1Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France.
Insights
Closed-loop (CL) insulin delivery improved glucose control in children with type 1 diabetes compared to threshold-low-glucose-suspend (TLGS). While nocturnal hypoglycemia was similar, CL enhanced time in target glucose ranges, showing promise for diabetes management.
Area of Science:
- Pediatric Endocrinology
- Diabetes Technology
- Metabolic Control
Background:
- Type 1 diabetes management in pre-pubertal children presents unique challenges.
- Automated insulin delivery systems aim to improve glycemic control and reduce burden.
- Comparing closed-loop (CL) systems with threshold-low-glucose-suspend (TLGS) is crucial for optimizing therapy.
Purpose of the Study:
- To compare the efficacy of closed-loop (CL) insulin pump delivery versus threshold-low-glucose-suspend (TLGS) for glucose control in pre-pubertal children with type 1 diabetes.
- To assess glycemic outcomes, including time in range and hypoglycemia, under supervised conditions.
- To evaluate user acceptance and identify limitations of current automated insulin delivery technologies.
Main Methods:
- A randomized crossover trial involving 24 pre-pubertal children (age 7-12) with type 1 diabetes.
- Participants underwent two 48-hour admissions, receiving either CL or TLGS insulin pump therapy in randomized order.
- Standardized meals, snacks, and physical activity were incorporated; meal boluses used individual insulin-to-carbohydrate ratios.
Main Results:
- Closed-loop (CL) therapy significantly improved time in target glucose ranges (3.9-10.0 mmol/L and 3.9-7.8 mmol/L) and mean continuous glucose monitoring (CGM) levels over 48 hours compared to TLGS (P < 0.001).
- Overnight (22:00-08:00) percentage of CGM time below 3.9 mmol/L was similar between CL and TLGS.
- Device disconnections and sensor inaccuracies at low glucose levels were identified as limiting factors for optimal CL control.
Conclusions:
- Closed-loop (CL) insulin delivery offers significant benefits in improving time in target glucose ranges for pre-pubertal children with type 1 diabetes compared to TLGS.
- While CL did not reduce nocturnal hypoglycemia, it demonstrated superior overall glycemic control and was well-accepted by participants.
- Further integration and improved accuracy of devices are needed to maximize the potential of CL systems in pediatric diabetes management.
Abstract:
This randomized control trial investigated glucose control with closed-loop (CL) versus threshold-low-glucose-suspend (TLGS) insulin pump delivery in pre-pubertal children with type 1 diabetes in supervised hotel conditions. The patients [n = 24, age range: 7-12, HbA1c: 7.5 ± 0.5% (58 ± 5 mmol/mol)] and their parents were admitted twice at a 3-week interval. CL control to range or TLGS set at 3.9 mmoL/L were assessed for 48 hour in randomized order. Admissions included three meals and one snack, and physical exercise. Meal boluses followed individual insulin/carb ratios. While overnight (22:00-08:00) per cent continuous glucose monitoring (CGM) time below 3.9 mmol/L (primary outcome) was similar, time in ranges 3.9 to 10.0 and 3.9 to 7.8 mmoL/L and mean CGM were all significantly improved with CL (P < 0.001). These results were confirmed over the whole 48 hour. Disconnections between devices and limited accuracy of glucose sensors in the hypoglycaemic range appeared as limiting factors for optimal control. CL mode was well accepted while fear of hypoglycaemia was unchanged. CL did not minimize nocturnal hypoglycaemia exposure but improved time in target range compared to TLGS. Although safe and well-accepted, CL systems would benefit from more integrated devices.
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