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

NCT07778147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-21

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes (T1D)

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.

Sponsors & Collaborators

  • Didem Güneş Kaya

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2020-11-19
Completion
2021-08-16

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778147 on ClinicalTrials.gov