A Randomized Crossover Trial to Compare Automated Insulin Delivery (the Artificial Pancreas) With Carbohydrate Counting or Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes
Primary result · Time in range 3.9-10.0 mmol/LResult — go to the resultMean difference −3.6 %Authors' conclusion
Though the qualitative meal-size estimation method achieved a high time in range and low time in hypoglycemia, noninferiority was not confirmed.
Study context
- Population
- Adults with T1D using AID; 20 women; age 44 (SD 17) years; A1C 7.4% [0.7%]30 completed
- Comparison
- AID with qualitative meal-size estimation vs AID with CHO counting
- Primary endpoint
- Time in range 3.9-10.0 mmol/L; noninferiority margin 4%
- Follow-up
- 3 weeks
Methodological detailstwo-center, crossover, noninferiority
- Two-center
- Crossover
- Noninferiority
Primary result
Time in range 3.9-10.0 mmol/L
Mean difference
−3.6 %
noninferiority P = 0.78
By group
As reported in the abstract
Further findings
Automated basal insulin delivery · higher with Qualitative meal-size estimation
P = 0.003
Safety
- Time <3.9 mmol/L low in both arms
- <1.6%
- Time <3.0 mmol/L low in both arms
- <0.2%
Original publication
A Randomized Crossover Trial to Compare Automated Insulin Delivery (the Artificial Pancreas) With Carbohydrate Counting or Simplified Qualitative Meal-Size Estimation in Type 1 Diabetes. Diabetes Care. Published 3 May 2023. doi:10.
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