Introduction and Objective: Individuals with early stage T1D may engage in LC (e.g., carbohydrate restriction, vitamin use) to delay progression. Little is known about use of LC in individuals in DMT trials. We characterized LC reported in DMT trials conducted by TrialNet.Methods: We analyzed pooled participant questionnaires from 6 DMT trials for prevention (n=4) or new onset c-peptide preservation (n=2). Adult/teen (≥10 years) participants and parents of child participants <18 years reported LC, diabetes distress, and beliefs about randomization and T1D risk. LC was collected either from a list (recognition) or self-report (recall).Results: Among 433 participants (70% teens) and 421 parents representing 617 unique participants (14.6±9.8 years, 44% female), 32% reported ≥1 LC, most often diets or supplements. Univariate logistic regression models were significant for LC survey type and trial type in both groups. For participants, age, overweight/obesity, and 1st degree relative with T1D were also associated with LC. For parents, distress was significant. In multivariate models, overweight/obesity (participants), survey type (parents), and distress (parents) remained significant. Beliefs about randomization group or T1D risk were not significant.Conclusion: About 1/3 of the cohort reported a LC. This was more common in parents with high distress and participants with high BMI. Future studies should assess how LC may impact trial outcomes.
C. March: None. D. Cuthbertson: None. L. Jacobsen: Consultant; Current; Sanofi. L. DiMeglio: Research Support; Ended; Dompé, Lilly. Stock/Shareholder; Ended; Lilly. Research Support; Current; MannKind Corporation. Research Support; Ended; Provention Bio, Inc. Research Support; Current; Sanofi. Research Support; Ended; Zealand Pharma A/S. Consultant; Current; Tandem Diabetes Care, Inc. Other – DSMB member; Current; Merck & Co., Inc., Lilly. K. Herold: Consultant; Current; Sanofi. Consultant; Ended; Dompé. S.B. Johnson: None.
Type 1 Diabetes TrialNet is funded by the National Institutes of Health (NIH) through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) U01 DK106993
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