Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study
Primary result · Time in range 3.9-10.0 mmol/LResult — go to the resultMean difference 13.2 percentage points 95% CI 9.5–16.9Authors' conclusion
Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adults with type 1 diabetes and suboptimal glycemic control.
Study context
- Population
- Adults with T1D using insulin pump therapy with suboptimal glycemic control; mean ± SD age 41 ± 12 years, HbA1c 9.2 ± 1.1% [77 ± 12 mmol/mol]
- Participants
- 26 adults
- Comparison
- Fully closed-loop with ultrarapid insulin lispro (CamAPS HX) vs insulin pump therapy with continuous glucose monitoring (CGM)
- Primary endpoint
- Proportion of time glucose in range 3.9-10.0 mmol/L
- Follow-up
- Two 8-week periods
Methodological detailssingle-centre
- Single-centre
Primary result
Time in range 3.9-10.0 mmol/L
Mean difference
13.2 percentage points
95% CI 9.5–16.9
P < 0.001
By group
Closed-loopvs Pump with CGM
mean difference 13.2 percentage points (95% CI 9.5–16.9); P < 0.001
As reported in the abstract
Further findings
Mean, %
| Outcome | Closed-loop | Pump with CGM | Mean difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Time with glucose >10.0 mmol/L | 49.0 (SD 9.9) | 62.9 (SD 12.6) | −13.3 (−17.2 to −9.5) | P < 0.001 | |
| −20−10010Difference, percentage points (linear scale) |
Mean, mmol/L
| Outcome | Closed-loop | Pump with CGM | Mean difference (mmol/L) (95% CI) | P value | |
|---|---|---|---|---|---|
| Mean glucose | 10.7 (SD 1.1) | 12.0 (SD 1.6) | −1.2 (−1.8 to −0.7) | P < 0.001 | |
| −2−101Difference, mmol/L (linear scale) |
Total daily insulin requirements · did not differ
P = 0.704
Safety
Median
| Outcome | Closed-loop | Pump with CGM | P value |
|---|---|---|---|
| Time with glucose <3.9 mmol/LSimilar between periods | 0.88% (IQR 0.51–1.55) | 0.64% (IQR 0.28–1.10) | P = 0.102 |
Severe hypoglycemia or DKA
- No severe hypoglycemia or ketoacidosis occurred
Original publication
Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study. Diabetes Care. Published 24 August 2023. doi:10. 2337/ dc23-0728
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