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Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month
Julia Ware1, Charlotte K Boughton2, Janet M Allen3
1Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK.
Insights
The Cambridge hybrid closed-loop system improved glucose control in children with type 1 diabetes. High system usage is key for optimal efficacy, as seen with the CamAPS FX configuration.
Area of Science:
- Endocrinology
- Biomedical Engineering
- Pediatric Diabetes Management
Background:
- Type 1 diabetes in children and adolescents often involves suboptimal glucose control.
- Closed-loop insulin delivery systems offer a potential solution for improved glycemic management.
Purpose of the Study:
- To compare the safety and efficacy of the Cambridge hybrid closed-loop algorithm against usual care in pediatric patients with type 1 diabetes over six months.
Main Methods:
- A multicentre, multinational randomized controlled trial involving 133 participants (aged 6-18 years) with type 1 diabetes.
- Participants were assigned to either the Cambridge closed-loop system (FlorenceM or CamAPS FX configurations) or usual insulin pump therapy.
- The primary endpoint was the change in HbA1c at six months.
Main Results:
- The closed-loop group showed a statistically significant reduction in HbA1c compared to the control group (difference of -3.5 mmol/mol).
- Efficacy varied by configuration, with consistently high usage (93%) in the CamAPS FX group leading to better outcomes than the FlorenceM group (40%).
- The safety profile was acceptable, with similar rates of severe hypoglycemia and comparable adverse events between groups.
Conclusions:
- The Cambridge hybrid closed-loop algorithm demonstrates an acceptable safety profile and improves glycemic control in pediatric type 1 diabetes.
- Consistent and high usage of the closed-loop system is crucial for achieving optimal efficacy, as highlighted by the CamAPS FX results.
Background:
Closed-loop insulin delivery systems have the potential to address suboptimal glucose control in children and adolescents with type 1 diabetes. We compared safety and efficacy of the Cambridge hybrid closed-loop algorithm with usual care over 6 months in this population.
Methods:
In a multicentre, multinational, parallel randomised controlled trial, participants aged 6-18 years using insulin pump therapy were recruited at seven UK and five US paediatric diabetes centres. Key inclusion criteria were diagnosis of type 1 diabetes for at least 12 months, insulin pump therapy for at least 3 months, and screening HbA1c levels between 53 and 86 mmol/mol (7·0-10·0%). Using block randomisation and central randomisation software, we randomly assigned participants to either closed-loop insulin delivery (closed-loop group) or to usual care with insulin pump therapy (control group) for 6 months. Randomisation was stratified at each centre by local baseline HbA1c. The Cambridge closed-loop algorithm running on a smartphone was used with either (1) a modified Medtronic 640G pump, Medtronic Guardian 3 sensor, and Medtronic prototype phone enclosure (FlorenceM configuration), or (2) a Sooil Dana RS pump and Dexcom G6 sensor (CamAPS FX configuration). The primary endpoint was change in HbA1c at 6 months combining data from both configurations. The primary analysis was done in all randomised patients (intention to treat). Trial registration ClinicalTrials.gov, NCT02925299.
Findings:
Of 147 people initially screened, 133 participants (mean age 13·0 years [SD 2·8]; 57% female, 43% male) were randomly assigned to either the closed-loop group (n=65) or the control group (n=68). Mean baseline HbA1c was 8·2% (SD 0·7) in the closed-loop group and 8·3% (0·7) in the control group. At 6 months, HbA1c was lower in the closed-loop group than in the control group (between-group difference -3·5 mmol/mol (95% CI -6·5 to -0·5 [-0·32 percentage points, -0·59 to -0·04]; p=0·023). Closed-loop usage was low with FlorenceM due to failing phone enclosures (median 40% [IQR 26-53]), but consistently high with CamAPS FX (93% [88-96]), impacting efficacy. A total of 155 adverse events occurred after randomisation (67 in the closed-loop group, 88 in the control group), including seven severe hypoglycaemia events (four in the closed-loop group, three in the control group), two diabetic ketoacidosis events (both in the closed-loop group), and two non-treatment-related serious adverse events. There were 23 reportable hyperglycaemia events (11 in the closed-loop group, 12 in the control group), which did not meet criteria for diabetic ketoacidosis.
Interpretation:
The Cambridge hybrid closed-loop algorithm had an acceptable safety profile, and improved glycaemic control in children and adolescents with type 1 diabetes. To ensure optimal efficacy of the closed-loop system, usage needs to be consistently high, as demonstrated with CamAPS FX.
Funding:
National Institute of Diabetes and Digestive and Kidney Diseases.
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