Fully Closed-Loop Improves Glycemic Control Compared with Pump with Continuous Glucose Monitoring (CGM) in Adolescents with Type 1 Diabetes and HbA1c Above Target: A Two-Center, Randomized Crossover Study
Primary result · TIR 3.9-10.0 mmol/LResult — go to the resultMean difference 12.9 percentage points 95% CI 8.5–17.3Authors' conclusion
FCL insulin delivery with CamAPS HX improved glucose outcomes compared with insulin pump therapy with CGM in adolescents with T1D and HbA1c above target.
Study context
- Population
- Adolescents (13–19 years) with T1D using insulin pump therapy with above-target HbA1c; mean age 16.2 years, median HbA1c 74 mmol/mol (8.9%)crossover
- Participants
- 24 adolescents
- Comparison
- Fully closed-loop (FCL) with Fiasp vs standard nonautomated insulin pump therapy with CGM
- FCLn = 24
- Pump with CGMn = 24reference
- Primary endpoint
- Percentage of time glucose in target range 3.9-10.0 mmol/L
- Follow-up
- 8-week periods
Methodological detailstwo-center, two 8-week periods, unrestricted living
- Two-center
- Two 8-week periods
- Unrestricted living
Primary result
TIR 3.9-10.0 mmol/L
Mean difference
12.9 percentage points
95% CI 8.5–17.3
P < 0.001
By group
FCLvs Pump with CGM
mean difference 12.9 percentage points (95% CI 8.5–17.3); P < 0.001
As reported in the abstract
Further findings
Median
| Outcome | FCL | Pump with CGM | Difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Time in hyperglycemia >13.9 mmol/L | 28.7% | 39.6% | −7.3 (−11.1 to −3.5) | P < 0.001 | |
| Time with glucose <3.9 mmol/L | 2.78% | 2.97% | −0.34 (−1.03 to 0.35) | P = 0.322 | |
| −15−10−505Difference, percentage points (linear scale) |
Mean, mmol/L
| Outcome | FCL | Pump with CGM | Difference (mmol/L) (95% CI) | P value | |
|---|---|---|---|---|---|
| Mean glucose | 11.1 | 12.7 | −1.2 (−1.8 to −0.5) | P < 0.001 | |
| −2−101Difference, mmol/L (linear scale) |
Median, mmol/mol
| Outcome | FCL | Pump with CGM | P value |
|---|---|---|---|
| HbA1c | 71 (8.6%) | 74 (8.9%) | P = 0.227 |
- Total daily insulin dose
- P = 0.276
Time with glucose <3.9 mmol/L
- Similar between interventions
HbA1c
- No difference in HbA1c
Total daily insulin dose
- No difference in total daily insulin dose
Safety
- No severe hypoglycemia or ketoacidosis occurred
Original publication
Fully Closed-Loop Improves Glycemic Control Compared with Pump with CGM in Adolescents with Type 1 Diabetes and HbA1c Above Target: A Two-Center, Randomized Crossover Study. Diabetes Technol Ther. Published 30 May 2025. doi:10.
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