Introduction: Time limited eating (TLE) improves β-cell function, increases insulin sensitivity, lowers fasting glucose, and increases time in range in adults with T2D. Objectives: This study aims to evaluate TLE in pediatric new-onset T1D, at which time residual β-cell function may be preserved. Aim 1) Evaluate feasibility, acceptability, and safety of TLE. Aim 2) Test impact of TLE on β-cell function and insulin sensitivity. Aim 3) Assess effectiveness of TLE on glycemic control. Methods: A randomized controlled trial of youth aged 12-25 years diagnosed with T1D within 12 months; randomization to intervention (8-hour feed/16-hour fast) or control group (≥12-hour feed) for an 8-week period. Feasibility is evaluated using questionnaires and adherence. Safety is indicated by hypoglycemia frequency. β-cell function is evaluated by mixed meal tolerance test (MMTT) with area under C-peptide curve (AUC). Glycemic control is evaluated by time in range (TIR 70-180 mg/dL) on CGM and HbA1c. Results: Six youths have entered, three have completed (2 intervention, 1 control). Participants in intervention group adhered to TLE ~94% of time. Both reported TLE felt safe, noted improved stability of glucose, chose to continue TLE after study ended, and would recommend to others with T1D. No increased hypoglycemia frequency noted on CGM. Participant 2 (intervention) had increase in AUC from baseline (87.45 to 152.4) and decrease in HbA1c (-1.3 percentage points), although participant 1 (intervention) had decrease in AUC and no change in HbA1c. Participant 3 (control) had increase in AUC and decrease in HbA1c, both changes less than participant 2. No improvement in TIR on CGM was demonstrated in either group. Conclusion: This is the only known study evaluating TLE in youth with T1D and has the potential to advance management of T1D by introducing meal-timing early in diagnosis. Thus far the intervention appears feasible and safe, however more data is needed. Recruitment continues to be underway. Disclosure C.Berman: None. A.Vidmar: Advisory Panel; Rhythm Pharmaceuticals, Inc., Research Support; Dexcom, Inc. J.J.Flores garcia: None. J.Raymond: None.
Background: The SEARCH for Diabetes in Youth Study has provided critical insights into the epidemiology of pediatric T2D. The 2021 report estimated an annual percent change (APC) in prevalence of 4.8% between 2009 to 2017. Multi-center longitudinal cohort studies generate robust data, but are time, resource, and effort intensive. Large real-world data repositories may offer cost-effective opportunities to validate and expand on these findings. Hypothesis: Youth-onset T2D prevalence is rising at a rate in excess of 5% per year in the US in the previous five years. Methods: We queried the Trinetx Research Network which includes EHR data from 58 institutions with 86,487,854 total patients. We included patients <22 years of age, who had at least one incidence of an E11 ICD-10 code for T2D associated with an ambulatory, emergency room, or inpatient encounter for each calendar year from 2016 to 2021. Patients with other diabetes ICD-10 codes (E08, E09, E10, or E13) were excluded. Summary statistics of the query cohort describing sex, race and ethnicity, labs, medications, and anthopometrics were extracted from the platform. Chi-squared test for trend was used to determine statistical significance in demographic change. Results: The mean APC in prevalence per center rose by 9.1% between 2016 to 2019 (2016: 127 cases/center, 5334 total cases; 2019: 166.2 cases/center, 7919 total cases) , but subsequently declined by 6.6% between 2019 to 2020. There was a consistent increase in the median BMI percentile over time from 2016 to 2021. The percentage of black youth diagnosed with T2D rose (from 30 to 33%, P<0.0001) whereas that of Hispanic youth was unchanged (25%, P=0.73) . The proportion of male also increased over time (P<0.0001) . Conclusion: Real-world data from Trinetx demonstrates a rising incidence of youth-onset T2D that parallels an increase in median BMI percentile. The decrease in case rate in 2020 may be the result of decreased encounters during the Covid-19 pandemic. The rising prevalence of T2D in black youth and male gender warrants further analysis, to understand the driver behind this trend. Disclosure L. Chao: None. A. Vidmar: None. J. Espinoza: Consultant; AI Health. Funding National Center for Advancing Translational Science (UL1TR001855 and UL1TR000130)
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