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Completed

NCT Number: NCT07778147

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

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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine

Istanbul, Fatih, 34098, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Mean Overnight Sensor Glucose

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

    Mean continuous glucose monitoring (CGM) glucose concentration during the overnight period following each bedtime snack intervention.

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

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

    Percentage of CGM readings within the glucose range of 70-140 mg/dL during the overnight period following each bedtime snack intervention.

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

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

    Percentage of CGM readings below 70 mg/dL during the overnight period following each bedtime snack intervention.

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

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

    Percentage of CGM readings below 54 mg/dL during the overnight period following each bedtime snack intervention.

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

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

    Percentage of CGM readings above 180 mg/dL during the overnight period following each bedtime snack intervention.

  6. Percentage of Overnight Time Above Range (>250 mg/dL)

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

    Percentage of CGM readings above 250 mg/dL during the overnight period following each bedtime snack intervention.

  7. Coefficient of Variation of Overnight Sensor Glucose

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

    Coefficient of variation of CGM glucose values during the overnight period, expressed as a percentage

  8. Peak Overnight Sensor Glucose

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

    Highest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention.

  9. Nadir Overnight Sensor Glucose

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

    Lowest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention.

  10. Peak-to-Nadir Overnight Glucose Amplitude

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

    Difference between the highest and lowest CGM glucose concentrations during the overnight period following each bedtime snack intervention.

  11. Incremental Area Under the Overnight Glucose Curve

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

    Incremental area under the CGM glucose curve during the overnight period following each bedtime snack intervention.

  12. Number of Overnight Hypoglycemic Events

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

    Number of hypoglycemic events occurring during the overnight period following each bedtime snack intervention.

  13. Number of Overnight Hyperglycemic Events

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

    Number of hyperglycemic events occurring during the overnight period following each bedtime snack intervention.

Sponsors and collaborators

Lead sponsor

Didem Güneş Kaya

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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