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Study design: Multicentre, parallel-group, open-label, randomised, phase 3 clinical trial. Treatment allocation blinded to statisticians and investigators undertaking data analyses.
Allocation: Randomisation to intervention or control group using minimisation, with the variables time in range (TIR), age, sex, diabetes duration and trial site.
Patients: 135 patients recruited from five tertiary paediatric diabetes centres in Australia. Patients were 12–25 years old with type 1 diabetes for ≥1 year, fasting c-peptide <0.3 ng/mL and HbA1c (glycated haemoglobin) <10.5%. There were 68 control (continuous subcutaneous insulin infusion or multiple daily insulin injections) and 67 intervention (hybrid closed loop (HCL) including training on insulin pump, glucose sensor and transmitter) patients. Exclusion criteria included existing use of HCL therapy and several medical/psychological conditions.
Outcomes
Primary: Percentage of time glucose level was …
Footnotes
Review of article Abraham M, de Bock M, Smith G, Dart J, Fairchild J, King B, et al. Effect of a hybrid closed loop system on glycemic and psychosocial outcomes in children and adolescents with type 1 diabetes. JAMA Pediatr 2021;175:1227.
Twitter @NilimaSingh2010
Contributors VH wrote the abstract. NS edited the abstract and wrote the commentary.
Provenance and peer review Commissioned; internally peer reviewed.
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