Eighteen-Month Hybrid Closed-Loop Use in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Trial
Primary result · TIR 3.9-10.0 mmol/LResult — go to the resultDifference 8.4 percentage points 95% CI 6.7–10.1Authors' conclusion
Use of the Cambridge hybrid CL system led to sustained improvements in glycemic control lasting more than 18 months in very young children with T1D.
Study context
- Population
- Very young children aged 1–7 years with T1D who completed a 16-week randomized crossover trial of hybrid closed-loop (CL) vs sensor-augmented pump (SAP); mean ± SD age 6.6 ± 1.5 years60 eligible
- Participants
- 49 children
- Comparison
- CL extension phase vs primary-phase SAP and primary-phase CL periods
- CL extensionn = 49
Methodological detailssingle-arm, multicenter, multinational, 18-month extension
- Single-arm
- Multicenter
- Multinational
- 18-month extension
Primary result
Time in range (TIR) 3.9-10.0 mmol/L
Difference
8.4 percentage points
95% CI 6.7–10.1
P < 0.001
CL extensionvs Primary-phase SAP
difference 8.4 percentage points (95% CI 6.7–10.1); P < 0.001
As reported in the abstract
Further findings
| Outcome | Difference (%) (95% CI) | P value | |
|---|---|---|---|
| HbA1cCL extensionvs Primary-phase SAPLower with CL extension; 5.0 mmol/mol (95% CI 3.7-6.2) | 0.4 (0.3–0.6) | P < 0.001 | |
| −0.500.51Difference, % (linear scale) |
| Outcome | CL extension | Primary-phase CL |
|---|---|---|
| HbA1c and TIR · 18 months | mean 6.7 (SD 0.5) % (HbA1c) | mean 6.7 (SD 0.5) % (HbA1c) |
| TIR | 70 ± 7% | 71 ± 6% |
- Time in hypoglycemia (<3.9 mmol/L) · CL extension vs Primary-phase SAP · similar
- P = 0.31
- Time in hypoglycemia (<3.9 mmol/L) · CL extension vs Primary-phase CL · similar
- P = 0.70
Safety
Serious adverse events during extension
- Severe hypoglycemia events
- 2
- Other serious adverse events
- 1
- Unexpected serious adverse device effect
- 1
Original publication
Eighteen-Month Hybrid Closed-Loop Use in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Trial. Diabetes Care. Published 17 October 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →