CamAPS FX Hybrid Closed-Loop with Ultra-Rapid Lispro Compared with Standard Lispro in Adults with Type 1 Diabetes: A Double-Blind, Randomized, Crossover Study
Primary result · TIR 3.9-10 mmol/LResult — go to the resultMean difference 2.5 percentage points 95% CI 0.8–4.2Authors' conclusion
The use of ultra-rapid lispro with CamAPS FX hybrid closed-loop increases time in range and reduces mean glucose with no difference in hypoglycemia compared with standard insulin lispro in adults with type 1 diabetes.
Study context
- Population
- Adults with T1D (mean ± SD age 44.5 ± 10.7 years, HbA1c 7.1 ± 0.9% [54 ± 10 mmol/mol])crossover
- Participants
- 28 adults
- Comparison
- HCL with ultra-rapid lispro vs HCL with standard insulin lispro
- Primary endpoint
- Proportion of time sensor glucose in target range (3.9-10 mmol/L [70-180 mg/dL])
Methodological detailssingle-centre, double-blind, crossover, Same CamAPS FX closed-loop algorithm used in both periods
- Single-centre
- Double-blind
- Crossover
- Same CamAPS FX closed-loop algorithm used in both periods
Primary result
TIR 3.9-10 mmol/L
Mean difference
2.5 percentage points
95% CI 0.8–4.2
P = 0.005
By group
Ultra-rapid lisprovs Standard insulin lispro
mean difference 2.5 percentage points (95% CI 0.8–4.2); P = 0.005
As reported in the abstract
Further findings
Mean sensor glucose · lower with ultra-rapid lispro
P = 0.048
Safety
Median
| Outcome | Ultra-rapid lispro | Standard insulin lispro | P value |
|---|---|---|---|
| Time sensor glucose <3.9 mmol/L [70 mg/dL]Similar between interventions | 2.3% (IQR 1.3%–2.7%) | 2.1% (IQR 1.4%–3.3%) | P = 0.33 |
Severe hypoglycaemia or ketoacidosis
- No severe hypoglycemia or ketoacidosis occurred
Original publication
CamAPS FX Hybrid Closed-Loop with Ultra-Rapid Lispro Compared with Standard Lispro in Adults with Type 1 Diabetes: A Double-Blind, Randomized, Crossover Study. Diabetes Technol Ther. Published 23 November 2023. doi:10. 1089/ dia. 2023. 0262
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