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 incre-mental 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.