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Weight Management in Young Adults with Type 1 Diabetes: The Advancing Care for Type 1 Diabetes and Obesity Network Sequential Multiple Assignment Randomized Trial Pilot Results.

AIMS
Co-management of weight and glycemia is critical yet challenging in type 1 diabetes (T1D). We evaluated the effect of a hypocaloric low carbohydrate, hypocaloric moderate low fat, and Mediterranean diet without calorie restriction on weight and glycemia in young adults with T1D and overweight or obesity.


MATERIALS AND METHODS
We implemented a nine-month Sequential, Multiple Assignment, Randomized Trial pilot among adults aged 19-30 years with T1D for ≥1 year and BMI 27-39.9 kg/m2 . Re-randomization occurred at 3- and 6-months if the assigned diet was not acceptable or not effective. We report results from the initial three-month diet period and rerandomization statistics prior to shutdowns due to COVID-19 for primary (weight, hemoglobin A1c [HbA1c], percent of time below range [%TBR] <70 mg/dL) and secondary outcomes (body fat percentage [BFP], percent of time in range [70-180 mg/dL], and %TBR <54 mg/dL). Models adjusted for design, demographic, and clinical covariates tested changes in outcomes and diet differences.


RESULTS
Adjusted weight and HbA1c (n=38) changed by -2.7 kg (95%CI -3.8, -1.5, p<0.0001) and -0.91 percentage points (95%CI -1.5, -0.30, p=0.005), respectively, while adjusted BFP remained stable, on average (p=0.21). Hypoglycemia indices remained unchanged, on average, following adjustment (n=28, p>0.05). Variability in all outcomes, including weight change, was considerable (57.9% were re-randomized primarily due to loss of <2% body weight). No outcomes varied by diet.


CONCLUSIONS
Three months of a diet, irrespective of macronutrient distribution or caloric restriction, resulted in weight loss while improving HbA1c levels without increasing hypoglycemia in adults with T1D. This article is protected by copyright. All rights reserved.