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.

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