Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes
Primary result · Time in range 70 to 180 mg/dLResult — go to the resultMean adjusted difference 12.4 percentage points 95% CI 9.5–15.3Authors' conclusion
In this trial involving young children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with a closed-loop system than with standard care.
Study context
- Population
- Children aged ≥2 to <6 years with T1D; baseline HbA1c 5.2 to 11.5%randomized 2:1
- Participants
- 102 children
- Comparison
- Closed-loop insulin delivery vs standard care
- Closed-loopn = 68
- Standard caren = 34reference
- Primary endpoint
- Percentage of time with glucose in target range 70 to 180 mg/dL, by CGM
- Follow-up
- 13-week follow-up
Methodological detailsmulticenter, randomized 2:1, Closed-loop initiation virtual in 55 patients (81%)
- Multicenter
- Randomized 2:1
- Closed-loop initiation virtual in 55 patients (81%)
Primary result
Time in range 70 to 180 mg/dL
Mean adjusted difference
12.4 percentage points
95% CI 9.5–15.3
P < 0.001
By group
Closed-loopvs Standard care
mean adjusted difference 12.4 percentage points (95% CI 9.5–15.3); P < 0.001
As reported in the abstract
Secondary outcomes
Time in range at baseline
Time >250 mg/dL, mean glucose, HbA1c, time <70 mg/dL
- Similar treatment effects favoring closed-loop on time >250 mg/dL, mean glucose and HbA1c
- No significant between-group difference in time <70 mg/dL
Safety
Events
| Outcome | Closed-loop | Standard care |
|---|---|---|
| Severe hypoglycemia | 2 | 1 |
| DKA | 1 | — not stated in the abstract |
— not stated in the abstract
Original publication
Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. Published 16 March 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →