Effects of Bedtime Snack Composition on Overnight Glucose in Children and Adolescents With Type 1 Diabetes
20. august 2026 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Fatih
-
Istanbul, Fatih, Tyrkia (Türkiye), 34098
- Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overnight Time in Range (70-180 mg/dL)
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Overnight Sensor Glucose
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
|
|
Coefficient of Variation of Overnight Sensor Glucose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. november 2020
Primær fullføring (Faktiske)
19. november 2020
Studiet fullført (Faktiske)
16. august 2021
Datoer for studieregistrering
Først innsendt
13. august 2026
Først innsendt som oppfylte QC-kriteriene
20. august 2026
Først lagt ut (Faktiske)
21. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BEDTIME-SNACK-T1D
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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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