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Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover

Roman Hovorka1, Janet M Allen, Daniela Elleri

  • 1Department of Paediatrics, University of Cambridge, Cambridge, UK. rh347@cam.ac.uk

Lancet (London, England)
|February 9, 2010
PubMed

Insights

Closed-loop insulin delivery systems show promise in controlling overnight blood glucose for young people with type 1 diabetes. These systems may reduce the risk of nocturnal hypoglycemia, improving diabetes management.

Area of Science:

  • Pediatric Endocrinology
  • Metabolic Disease Research
  • Biomedical Engineering

Background:

  • Type 1 diabetes management in young people presents unique challenges, particularly overnight glucose control.
  • Continuous glucose monitoring and insulin delivery systems offer potential solutions.
  • Nocturnal hypoglycemia is a significant risk in pediatric type 1 diabetes management.

Purpose of the Study:

  • To evaluate the efficacy of closed-loop insulin delivery systems in controlling overnight blood glucose levels in children and adolescents with type 1 diabetes.
  • To compare closed-loop system performance against standard continuous subcutaneous insulin infusion therapy.
  • To assess the impact of different meal absorption rates and exercise on closed-loop system performance.

Main Methods:

  • Three randomized crossover studies involving 19 patients (aged 5-18 years) with type 1 diabetes.
  • Comparison of closed-loop insulin delivery with standard continuous subcutaneous insulin infusion.
  • Evaluation of closed-loop system performance after rapidly and slowly absorbed meals and after exercise.
  • Primary outcome: time within the target blood glucose range (3.91-8.00 mmol/L) and time below 3.90 mmol/L.

Main Results:

  • Pooled data analysis showed a significant increase in time spent within the target glucose range (60% vs. 40%, p=0.0022) during closed-loop delivery.
  • Closed-loop systems significantly reduced time with glucose concentrations below 3.90 mmol/L (2.1% vs. 4.1%, p=0.0304).
  • No severe hypoglycemic events (<3.0 mmol/L) were recorded with closed-loop systems, compared to nine with standard treatment.

Conclusions:

  • Closed-loop insulin delivery systems demonstrate potential for improved overnight glycemic control in pediatric patients with type 1 diabetes.
  • These systems may significantly reduce the risk of nocturnal hypoglycemia in this population.
  • Further research and implementation of closed-loop technology can enhance diabetes management for young individuals.
Abstract

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