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Meta-analysis of overnight closed-loop randomized studies in children and adults with type 1 diabetes: the Cambridge
Kavita Kumareswaran1, Daniela Elleri, Janet M Allen
1Institute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom.
Insights
Overnight closed-loop insulin delivery significantly improved glycemic control in young people and adults with type 1 diabetes mellitus (T1DM). This advanced system reduced time below and above target glucose levels, enhancing safety and efficacy compared to conventional methods.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Biomedical Engineering
Background:
- Type 1 diabetes mellitus (T1DM) requires continuous glucose monitoring and management.
- Conventional continuous subcutaneous insulin infusion (CSII) has limitations in achieving optimal glycemic control, especially overnight.
- Closed-loop insulin delivery systems offer a potential advancement in automated diabetes management.
Purpose of the Study:
- To compare the safety and efficacy of overnight closed-loop insulin delivery versus conventional CSII in T1DM patients.
- To evaluate performance in two distinct age groups: young people (5-18 years) and adults.
- To analyze data from previously published randomized controlled trials.
Main Methods:
- A meta-analysis of four randomized crossover studies involving 17 children/adolescents and 24 adults.
- Overnight interventions included closed-loop systems and conventional CSII, with subjects experiencing both in random order.
- Specific scenarios mimicking real-life conditions were used, including post-meal and post-exercise (pediatric) or post-meal with alcohol (adult) glucose challenges.
Main Results:
- Overnight closed-loop significantly increased time in target plasma glucose range for both young people (40% to 60%) and adults (50% to 76%).
- Combined analysis showed a substantial increase in time in target range (43% to 71%) with closed-loop systems.
- Closed-loop reduced time spent in hypoglycemia (below 3.91 mmol/liter) and hyperglycemia (above 8.0 mmol/liter), and lowered glycemic variability.
Conclusions:
- Overnight closed-loop insulin delivery demonstrates improved glycemic control in T1DM patients across different age groups.
- The system effectively reduces nocturnal hypoglycemia and hyperglycemia, enhancing overall diabetes management.
- Closed-loop technology represents a promising advancement for individuals with T1DM, improving safety and efficacy.
Aim:
We reviewed the safety and efficacy of overnight closed-loop insulin delivery compared with conventional continuous subcutaneous insulin infusion (CSII) in two distinct age groups with type 1 diabetes mellitus (T1DM), young people aged 5 to 18 years and adults, combining data of previously published randomized studies.
Methods:
We evaluated four randomized crossover studies in 17 children and adolescents [13.4 ± 3.6 years; mean ± standard deviation (SD)] and 24 adults (37.5 ± 9.1 years) on 45 closed-loop (intervention) and 45 CSII (control) visits. Each subject attended for two overnight study visits, using either closed-loop or conventional pump therapy, in random order. In each age group, studies were designed to mimic realistic likely scenarios. In the children and adolescent studies, closed loop was used following a standard evening meal and following 40 min of moderate-intensity exercise. In the adult studies, closed loop was commenced following a 60 g carbohydrate meal or a 100 g carbohydrate meal accompanied by alcohol. The primary outcome measure was time for which plasma glucose was within target range (3.91-8.0 mmol/liter).
Results:
Overnight closed loop increased the time in target plasma glucose in both young (from 40% to 60%, p = .002) and adults (from 50% to 76%, p < .001) compared with conventional CSII. Combined analysis showed an increase from 43% to 71% with closed loop (p < .001). Additionally, closed loop reduced the time spent below 3.91 mmol/liter and above 8.0 mmol/liter, from 4.1% to 2.1% (p = .01) and 33% to 20% (p = .03), respectively. Glycemic variability, as measured by the SD of plasma glucose, was lower during closed loop compared with CSII (1.5 versus 2.1 mmol/liter, p = .007).
Conclusions:
Overnight closed loop may improve glycemic control and reduce nocturnal hypoglycemia in both young people and adults with T1DM.
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