Randomized clinical trial to evaluate the effect on postprandial glycemia of Nutren Control®, a glycemia-targeted specialized supplement, compared to standardized breakfast in patients with type-2 diabetes: the CONTROL DIABETES study.

Objective: to evaluate the effects of a new glycemia targeted specialized supplement (GTSS) compared to a standard breakfast on postprandial blood glucose (PPG). Methods: patients with type 2 diabetes (T2D) and suboptimal control (A1C between 6.5 and 8.5 %) in monotherapy with metformin were included to this prospective, randomized, crossover trial. The standardized breakfast was isoenergetic compared to the GTSS, differing on macronutrients distribution. Both interventions were used once a day in the morning, each replacing breakfast for 7 consecutive days (14 days of observation). Intermittent scanning continuous glucose monitoring system (isCGM) determined the difference between the interventions regarding the incremental area under the curve (iAUC) of the PPG (3 hours after intervention), as a primary endpoint; secondary endpoints were the difference between the interventions regarding the glycemic peak, postprandial glucose excursion (PPGE), mean blood glucose (MBG) and time in range (TIR). Results: thirty-one T2D patients with ages between 39 and 69 years-old were enrolled. GTSS group had significantly lower iAUC of the PPG compared to standardized breakfast (33.3 [15.0 to 54.0] vs 46.8 [27.3 to 75.1] mg/dL), while also presenting a significantly lower PPG excursion (26.4 ± 17.2 vs 44.8 ± 24.4 mg/dL). There was no difference between the intervention periods regarding MBG, TIR and hypoglycemic events. Conclusion: The new GTSS, as a meal replacement in the breakfast, produced a 25 % reduction in the iAUC of the PPG, as accessed by isCGM, in comparison with an isocaloric-standardized meal.