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Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial
Martin Tauschmann1, Hood Thabit2, Lia Bally3
1Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK.
Hybrid closed-loop insulin delivery significantly improved glucose control in type 1 diabetes patients. This advanced system reduced time spent in hyperglycemia and hypoglycemia compared to sensor-augmented pump therapy.
Area of Science:
- Endocrinology
- Biomedical Engineering
- Clinical Research
Background:
- Glycaemic control is a persistent challenge for individuals with type 1 diabetes (T1D).
- Suboptimal glycaemic control increases the risk of long-term diabetes complications.
Purpose of the Study:
- To evaluate the effectiveness of hybrid closed-loop (HCL) insulin delivery versus sensor-augmented pump (SAP) therapy.
- To assess HCL therapy's impact on glycaemic control in T1D patients with suboptimal control.
Main Methods:
- An open-label, multicentre, multinational, parallel randomised controlled trial.
- Participants (aged 6+) with T1D and HbA1c 7.5-10.0% were randomized to HCL or SAP therapy for 12 weeks.
- Primary endpoint: time in target glucose range (3.9-10.0 mmol/L) at 12 weeks.
Main Results:
- HCL therapy significantly increased time in target glucose range (65% vs 54%, p<0.0001).
- HCL therapy led to a greater reduction in HbA1c compared to SAP (0.36% difference, p<0.0001).
- Reduced time spent in hypoglycemia and hyperglycemia was observed with HCL therapy; no significant difference in insulin dose or bodyweight.
Conclusions:
- Hybrid closed-loop insulin delivery is effective in improving glucose control in T1D.
- HCL therapy reduces hypoglycaemia risk and enhances time in target glucose range for patients with suboptimal control.
- This technology offers a promising advancement for managing type 1 diabetes across various age groups.
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