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

NCT07778147 | Completed

• 1 other identifier: BEDTIME-SNACK-T1D
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Bedtime snack; Nocturnal glycemia; Continuous glucose monitoring; Time in range; Glycemic variability; Macronutrient composition; Multiple daily injections; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• Overnight Time in Range (70-180 mg/dL)

  Percentage of continuous glucose monitoring (CGM) readings within the target glucose range of 70-180 mg/dL during the overnight period following each bedtime snack intervention.

  12 hours after bedtime snack consumption (21:00-09:00)

Secondary Outcomes (13)

• Mean Overnight Sensor Glucose

  12 hours after bedtime snack consumption (21:00-09:00)

• Percentage of Overnight Time in Tight Range (70-140 mg/dL)vernight Sensor Glucose

  12 hours after bedtime snack consumption (21:00-09:00)

• Percentage of Overnight Time Below Range (<70 mg/dL)

  12 hours after bedtime snack consumption (21:00-09:00)

• Percentage of Overnight Time Below Range (<54 mg/dL)

  12 hours after bedtime snack consumption (21:00-09:00)

• Percentage of Overnight Time Above Range (>180 mg/dL)

  12 hours after bedtime snack consumption (21:00-09:00)

Study Arms (4)

Sequence 1: CHO First

EXPERIMENTAL

Participants received the four bedtime snack interventions in the following order: CHO, CHO+PRO, CHO+FAT, and CHO+FIB.

Other: Carbohydrate-Only Bedtime Snack; Other: Carbohydrate-Plus-Protein Bedtime Snack; Other: Carbohydrate-Plus-Fat Bedtime Snack; Other: Carbohydrate-Plus-Fiber Bedtime Snack

Sequence 2: CHO+PRO First

EXPERIMENTAL

Participants received the four bedtime snack interventions in the following order: CHO+PRO, CHO+FAT, CHO+FIB, and CHO.

Other: Carbohydrate-Only Bedtime Snack; Other: Carbohydrate-Plus-Protein Bedtime Snack; Other: Carbohydrate-Plus-Fat Bedtime Snack; Other: Carbohydrate-Plus-Fiber Bedtime Snack

Sequence 3: CHO+FAT First

EXPERIMENTAL

Participants received the four bedtime snack interventions in the following order: CHO+FAT, CHO+FIB, CHO, and CHO+PRO.

Other: Carbohydrate-Only Bedtime Snack; Other: Carbohydrate-Plus-Protein Bedtime Snack; Other: Carbohydrate-Plus-Fat Bedtime Snack; Other: Carbohydrate-Plus-Fiber Bedtime Snack

Sequence 4: CHO+FIB First

EXPERIMENTAL

Participants received the four bedtime snack interventions in the following order: CHO+FIB, CHO, CHO+PRO, and CHO+FAT.

Other: Carbohydrate-Only Bedtime Snack; Other: Carbohydrate-Plus-Protein Bedtime Snack; Other: Carbohydrate-Plus-Fat Bedtime Snack; Other: Carbohydrate-Plus-Fiber Bedtime Snack

Interventions

Carbohydrate-Only Bedtime Snack OTHER

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.

Sequence 1: CHO First; Sequence 2: CHO+PRO First; Sequence 3: CHO+FAT First; Sequence 4: CHO+FIB First

Carbohydrate-Plus-Protein Bedtime Snack OTHER

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.

Sequence 1: CHO First; Sequence 2: CHO+PRO First; Sequence 3: CHO+FAT First; Sequence 4: CHO+FIB First

Carbohydrate-Plus-Fat Bedtime Snack OTHER

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.

Sequence 1: CHO First; Sequence 2: CHO+PRO First; Sequence 3: CHO+FAT First; Sequence 4: CHO+FIB First

Carbohydrate-Plus-Fiber Bedtime Snack OTHER

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.

Sequence 1: CHO First; Sequence 2: CHO+PRO First; Sequence 3: CHO+FAT First; Sequence 4: CHO+FIB First

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 6-18 years Diagnosis of type 1 diabetes for more than 1 year Completion of the remission period Treatment with multiple daily insulin injections Completion of all three stages of carbohydrate-counting education Ability to perform capillary blood glucose monitoring at least four times daily Total daily insulin dose \>0.5 U/kg/day Mean HbA1c \<9.6% during the preceding 3 months

You may not qualify if:

• Insulin pump or sensor-augmented pump therapy Incomplete carbohydrate-counting education Impaired awareness of hypoglycemia Intestinal malabsorption Delayed gastric emptying Celiac disease or any other condition requiring dietary restriction Cystic fibrosis or other gastrointestinal disorders Diabetes-related chronic complications Physical or mental disability limiting adherence to study procedures Eating behavior disorders Active infection

Sponsors & Collaborators

• Didem Güneş Kaya: lead

Study Sites (1)

Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each participant received all four bedtime snack interventions in a randomized order. Each snack condition was administered for three consecutive nights. No washout period was included because the interventions consisted of acute bedtime snacks and outcomes were assessed during the same overnight period following each snack.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 21, 2026
• Study Start: November 19, 2020
• Primary Completion: November 19, 2020
• Study Completion: August 16, 2021
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)