Clinical Application of the Food Insulin Index for Mealtime Insulin Dosing in Adults with Type 1 Diabetes: A Randomized Controlled Trial.

BACKGROUND: The Food Insulin Index (FII) is a novel algorithm for ranking foods based on their insulin demand relative to an isoenergetic reference food. We compared the effect of carbohydrate counting (CC) versus the FII algorithm for estimating insulin dosage on glycemic control in type 1 diabetes.

MATERIALS AND METHODS: In a randomized, controlled trial, adults (n = 26) using insulin pump therapy were assigned to using either traditional CC or the novel Food Insulin Demand (FID) counting for 12 weeks. Subjects participated in group education and individual sessions. At baseline and on completion of the trial, glycated hemoglobin A1c (HbA1c), day-long glycemia (6-day continuous glucose monitoring), fasting lipids, and C-reactive protein were determined.

RESULTS: Changes in HbA1c from baseline to 12 weeks were small and not significant in both groups (mean ± SEM; FII vs. CC, -0.1 ± 0.1% vs. -0.3 ± 0.2%; P = 0.855). The incremental area under the curve following breakfast declined significantly among the FID counters with no change in the CC group (FID vs. CC, -93 ± 41 mmol/L/min [P = 0.043] vs. 4 ± 50 mmol/L/min [P = 0.938]; between groups, P = 0.143). The mean amplitude of the glycemic excursion (MAGE) was significantly reduced among the FID counters (FID vs. CC, -6.1 ± 1.0 vs. -1.3 ± 1.0 mmol/L; P = 0.003), and only the FID counters experienced a trend (-44% vs. +11%; P = 0.057) to reduced hypoglycemia.

CONCLUSIONS: In a 12-week pilot study, MAGE and postprandial glycemia following breakfast were significantly improved with FII counting versus CC, despite no significant differences in HbA1c.