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NCT07778147
NA

Effects of Bedtime Snack Composition on Overnight Glucose in Children and Adolescents With Type 1 Diabetes

Sponsor: Didem Güneş Kaya

View on ClinicalTrials.gov

Summary

This study compared four types of bedtime snacks in children and adolescents with type 1 diabetes treated with multiple daily insulin injections. The aim was to determine whether bedtime snack nutrient composition affects overnight glucose levels. Participants received four different bedtime snacks: carbohydrate alone, carbohydrate with protein, carbohydrate with fat, and carbohydrate with fiber. The order of the four snack types was randomly assigned. Each snack type was consumed at 9:00 PM for three consecutive nights without an additional insulin dose for the snack. All participants received all four snack types during the study. Overnight glucose levels were measured from 9:00 PM to 9:00 AM using a blinded continuous glucose monitoring system. The primary outcome was the percentage of time glucose levels remained between 70 and 180 mg/dL during the overnight period. Secondary outcomes included measures of hypoglycemia, hyperglycemia, glucose variability, and changes in glucose levels during different periods of the night.

Official title: Bedtime Snack Composition and Overnight Glycemic Profiles in Children and Adolescents With Type 1 Diabetes Using Multiple Daily Injections: A Randomized Crossover Study

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2020-11-19

Completion Date

2021-08-16

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

OTHER

Carbohydrate-Only Bedtime Snack

Participants consumed an apple as a carbohydrate-only bedtime snack at 21:00. The snack was consumed within 10 minutes, and no additional bolus insulin was administered for the snack. This intervention was followed for three consecutive nights.

OTHER

Carbohydrate-Plus-Protein Bedtime Snack

Participants consumed a high-protein fresh cheese bedtime snack containing carbohydrate and protein at 21:00. The snack was consumed within 10 minutes, and no additional bolus insulin was administered for the snack. This intervention was followed for three consecutive nights.

OTHER

Carbohydrate-Plus-Fat Bedtime Snack

Participants consumed an apple with nuts as a carbohydrate-plus-fat bedtime snack at 21:00. The snack was consumed within 10 minutes, and no additional bolus insulin was administered for the snack. This intervention was followed for three consecutive nights.

OTHER

Carbohydrate-Plus-Fiber Bedtime Snack

Participants consumed rye crispbread as a carbohydrate-plus-fiber bedtime snack at 21:00. The snack was consumed within 10 minutes, and no additional bolus insulin was administered for the snack. This intervention was followed for three consecutive nights.

Locations (1)

Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine

Istanbul, Fatih, Turkey (Türkiye)