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.
Objective: A subset of youth with T1D experience ongoing challenges with diabetes self-management, often due to social risk. This 5-site study examined which social factors were associated with hemoglobin A1c (A1c) , specifically in youth with preexisting high A1c. Methods: Youth with T1D for more than 1 year were included if between 12-17 years old and with at least one A1c value ≥10% in the past year. Chart review captured A1c values, and caregivers reported on social risk- with 16 risk variables (e.g., housing security, employment status) in initial analyses. Multivariable linear regression model included A1c from 1 year prior to enrollment as an outcome and backwards stepwise procedure retained covariates with p<0.10. Results: Participants (n=130) had a mean age of 14.4 (±1.6) years and mean A1c of 11.1 (±1.7) ; 49% reported male gender; 51% self-identified as Non-Hispanic White. A1c prior to study enrollment was predicted to be 0.68 lower in individuals whose caregiver had at least a college education and 0.65 higher when caregivers were divorced or separated. Conclusion: Findings suggest that, in youth with preexisting difficulty with glycemic variability, caregiver education level and marital status are associated with A1c - and, while not causal, may reflect unique value when screening for risk. This cohort will be followed to determine which factors predict future health concerns and associated need for intervention. Disclosure D.V.Wagner: None. L.Yglecias: None. J.J.Flores garcia: None. E.Salcedo-rodriguez: None. A.Torres sanchez: None. P.Dasika: None. J.Viana: None. D.D.Williams: None. D.Ferro: None. M.A.Harris: None. M.A.Clements: Consultant; Glooko, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. J.Raymond: None. J.C.Wong: Consultant; Provention Bio, Inc., Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. A.Reed: None. D.Naranjo: None. C.Jenisch: None. C.Cruz: None. S.Mitchell: None. Funding JDRF
Background: Historically disadvantaged, ethnically- and racially-diverse AYA experience significantly greater challenges with T1D management when compared to White peers. To address this inequity, the patient-centered CoYoT1 Care model was adapted and implemented at a T1D clinic serving primarily ethnically- and racially-diverse AYA. Methods: In a randomized controlled 2x2 trial, 68 AYA received either CoYoT1 Care or Standard Care via in-person or Telehealth (TH) . Hemoglobin A1c (A1c) and T1D-related distress were measured at baseline and after four quarterly clinic visits, and analyzed via linear mixed models adjusting for age, sex, and attendance. Results: At study end, participants in TH showed reduced A1c (p=0.01) and no changes in physician-related distress (p=0.04) , compared to increased A1c and distress in those randomized to in-person care. Secondary analyses revealed that these TH benefits were attributable to Latinx AYA subgroup. Compared to Latinx participants randomized to in-person care, those in TH showed significant reductions in A1c (p=0.003; Figure) and physician distress (p=0.008) . Among non-Latinx participants, no significant differences in A1c or distress were observed. Conclusion: The TH CoYoT1 Care model engages underserved, ethnically-diverse AYA and leads to improved outcomes. Next steps include collaborating with stakeholders to adapt and implement the model nationwide. Disclosure J.J.Flores garcia: None. M.W.Reid: None. E.Pyatak: Research Support; Abbott Diabetes. J.L.Fogel: None. D.Fox: None. E.Salcedo-rodriguez: None. J.Raymond: None.
Background: VPG have been shown to improve psychosocial well-being in AYA with T1D, but it is unknown what aspects of VPG are most or least valued. Methods: CoYoT1 to California is a 15 month randomized controlled trial for patients ages 16-25 with T1D. AYA received Usual Care (n=28) or CoYoT1 Care (n=40) , which consisted of patient-centered provider visits and bimonthly VPG led by a YA with T1D. VPG were AYA-driven discussions focused on topics pertinent to AYA with T1D, emphasizing problem-solving and emotional support. At study end, VPG participants responded to a survey about their preferences for intervention features. Results: CoYoT1 Care patients were 40% female, 53% Latinx, and 72% publicly insured; and they attended 1.9 VPG each on average. AYA who attended at least one VPG participated in 4.1 VPG on average. The average session had 4.5 AYA present; each topic was covered by 9.6 AYA on average. Most survey respondents (75%) reported VPG were extremely or very valuable in supporting their T1D care. Seeing peers use diabetes technology and being supported by same-aged peers with T1D increased VPG value the most. Larger group size and not feeling comfortable sharing decreased value the most. Conclusion: Peer interactions may support unmet needs of AYA with T1D from diverse backgrounds. Further work will help optimize the design of VPG based on patient preferences. Disclosure D.I.Bisno: None. E.Pyatak: Research Support; Abbott Diabetes. M.W.Reid: None. D.Fox: None. J.L.Fogel: None. E.Salcedo-rodriguez: None. J.J.Flores garcia: None. A.Torres sanchez: None. J.Raymond: None. Funding The Donaghue Foundation
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