Effects of Bedtime Snack Composition on Overnight Glucose in Children and Adolescents With Type 1 Diabetes
20 augusti 2026 uppdaterad av: Didem Güneş Kaya
Bedtime Snack Composition and Overnight Glycemic Profiles in Children and Adolescents With Type 1 Diabetes Using Multiple Daily Injections: A Randomized Crossover Study
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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Fatih
-
Istanbul, Fatih, Turkiet (Türkiye), 34098
- Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Sequence 1: CHO First
Participants received the four bedtime snack interventions in the following order: CHO, CHO+PRO, CHO+FAT, and CHO+FIB.
|
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.
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.
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.
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.
|
|
Experimentell: Sequence 2: CHO+PRO First
Participants received the four bedtime snack interventions in the following order: CHO+PRO, CHO+FAT, CHO+FIB, and CHO.
|
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.
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.
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.
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.
|
|
Experimentell: Sequence 3: CHO+FAT First
Participants received the four bedtime snack interventions in the following order: CHO+FAT, CHO+FIB, CHO, and CHO+PRO.
|
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.
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.
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.
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.
|
|
Experimentell: Sequence 4: CHO+FIB First
Participants received the four bedtime snack interventions in the following order: CHO+FIB, CHO, CHO+PRO, and CHO+FAT.
|
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.
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.
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.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overnight Time in Range (70-180 mg/dL)
Tidsram: 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.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Overnight Sensor Glucose
Tidsram: 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.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Percentage of Overnight Time in Tight Range (70-140 mg/dL)vernight Sensor Glucose
Tidsram: 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.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Percentage of Overnight Time Below Range (<70 mg/dL)
Tidsram: 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.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Percentage of Overnight Time Below Range (<54 mg/dL)
Tidsram: 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.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Percentage of Overnight Time Above Range (>180 mg/dL)
Tidsram: 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.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Percentage of Overnight Time Above Range (>250 mg/dL)
Tidsram: 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.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
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Coefficient of Variation of Overnight Sensor Glucose
Tidsram: 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
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Peak Overnight Sensor Glucose
Tidsram: 12 hours after bedtime snack consumption (21:00-09:00)
|
Highest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Nadir Overnight Sensor Glucose
Tidsram: 12 hours after bedtime snack consumption (21:00-09:00)
|
Lowest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Peak-to-Nadir Overnight Glucose Amplitude
Tidsram: 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.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Incremental Area Under the Overnight Glucose Curve
Tidsram: 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 hours after bedtime snack consumption (21:00-09:00)
|
|
Number of Overnight Hypoglycemic Events
Tidsram: 12 hours after bedtime snack consumption (21:00-09:00)
|
Number of hypoglycemic events occurring during the overnight period following each bedtime snack intervention.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
|
Number of Overnight Hyperglycemic Events
Tidsram: 12 hours after bedtime snack consumption (21:00-09:00)
|
Number of hyperglycemic events occurring during the overnight period following each bedtime snack intervention.
|
12 hours after bedtime snack consumption (21:00-09:00)
|
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 november 2020
Primärt slutförande (Faktisk)
19 november 2020
Avslutad studie (Faktisk)
16 augusti 2021
Studieregistreringsdatum
Först inskickad
13 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2026
Första postat (Faktisk)
21 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BEDTIME-SNACK-T1D
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified individual participant data underlying the results reported in the publication may be shared upon reasonable request, subject to ethical and privacy restrictions and applicable institutional requirements.
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