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.

Abstract

Qualitative meal-size estimation has been proposed instead of quantitative carbohydrate (CHO) counting with automated insulin delivery. We aimed to assess the noninferiority of qualitative meal-size estimation strategy. We conducted a two-center, randomized, crossover, noninferiority trial to compare 3 weeks of automated insulin delivery with 1) CHO counting and 2) qualitative meal-size estimation in adults with type 1 diabetes. Qualitative meal-size estimation categories were low, medium, high, or very high CHO and were defined as <30 g, 30-60 g, 60-90 g, and >90 g CHO, respectively. Prandial insulin boluses were calculated as the individualized insulin to CHO ratios multiplied by 15, 35, 65, and 95, respectively. Closed-loop algorithms were otherwise identical in the two arms. The primary outcome was time in range 3.9-10.0 mmol/L, with a predefined noninferiority margin of 4%. A total of 30 participants completed the study (n = 20 women; age 44 (SD 17) years; A1C 7.4% [0.7%]). The mean time in the 3.9-10.0 mmol/L range was 74.1% (10.0%) with CHO counting and 70.5% (11.2%) with qualitative meal-size estimation; mean difference was -3.6% (8.3%; noninferiority P = 0.78). Frequencies of times at <3.9 mmol/L and <3.0 mmol/L were low (<1.6% and <0.2%) in both arms. Automated basal insulin delivery was higher in the qualitative meal-size estimation arm (34.6 vs. 32.6 units/day; P = 0.003). Though the qualitative meal-size estimation method achieved a high time in range and low time in hypoglycemia, noninferiority was not confirmed.