Should the Amounts of Fat and Protein Be Taken into Consideration to Calculate the Lunch Prandial Insulin Bolus? Results from a Randomized Crossover Trial.

Abstract Background: Concerning continuous subcutaneous insulin infusion (CSII), there are controversial results related to changes in glycemic response according to the meal composition and bolus design. Our aim is to determine whether the presence of protein and fat in a meal could involve a different postprandial glycemic response than that obtained with only carbohydrates (CHs). Subjects and Methods: This was a crossover, randomized clinical trial. Seventeen type 1 diabetes (T1D) patients on CSII wore a blinded continuous glucose monitoring system sensor for 3 days. They ingested two meals (meal 1 vs. meal 2) with the same CH content (50 g) but different fat (8.9 g vs. 37.4 g) and protein (3.3 g vs. 28.9 g) contents. A single-wave insulin bolus was used, and the interstitial glucose values were measured every 30 min for 3 h. We evaluated the different postprandial glycemic response between meal 1 and meal 2 by using mixed-effects models. Results: The postmeal glucose increase was 22 mg/dL for meal 1 and 31 mg/dL for meal 2. In univariate analysis, at different times not statistically significant differences in glucose levels between meals occurred. In mixed-model analysis, a time×meal interaction was found, indicating a different response between treatments along the time. However, most of the patients remained in the normoglycemic range (70-180 mg/dL) during the 3-h postmeal period (84.4% for meal 1 and 93.1% for meal 2). Conclusions: The presence of balanced amounts of protein and fat determined a different glycemic response from that obtained with only CH up to 3 h after eating. The clinical relevance of this finding remains to be elucidated.