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Time Limited Eating for Type 1 Diabetes (TLET1D Trial)

N/A

Waitlist Available

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 weeks; hba1c: baseline and 9 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a specific eating pattern in children recently diagnosed with Type 1 Diabetes. The goal is to see if this eating pattern can help the pancreas work better and improve blood sugar control.

Eligible Conditions

Type 1 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 weeks; hba1c: baseline and 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 weeks; hba1c: baseline and 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 weeks; hba1c: baseline and 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey"

Change in glycemic control at 9 weeks, as indicated by continuous glucose monitoring (percent time in range), and HbA1c

Change in β-cell function at 9 weeks, as indicated by mixed meal tolerance test with C-peptide levels

+1 more

Secondary study objectives

Anxiety, as indicated by Neuro-QOL-Anxiety-Short Form

Binge Eating, as indicated by Binge Eating Disorder Screener

Dietary patterns, as indicated by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention - Time Limited EatingExperimental Treatment1 Intervention

* includes an 8-hour feed/16-hour fast for 7 days per week * will be instructed to consume all of their calories in the afternoon/evening period * can consume non-caloric beverages (water, tea, coffee) during the fasting period * will wear a continuous glucose monitor * no caloric restriction will be used

Group II: Control - Standard CareActive Control1 Intervention

* includes a minimum 12-hour feeding window for 7 days per week * no caloric restriction will be used * will wear a continuous glucose monitor

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