Effects of Bedtime Snack Composition on Overnight Glucose in Children and Adolescents With Type 1 Diabetes
torstai 20. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
20
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
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Fatih
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Istanbul, Fatih, Turkki (Türkiye), 34098
- Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Sequence 1: CHO First
Participants received the four bedtime snack interventions in the following order: CHO, CHO+PRO, CHO+FAT, and CHO+FIB.
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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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Overnight Time in Range (70-180 mg/dL)
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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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.
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12 hours after bedtime snack consumption (21:00-09:00)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Mean Overnight Sensor Glucose
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Mean continuous glucose monitoring (CGM) glucose concentration during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of Overnight Time in Tight Range (70-140 mg/dL)vernight Sensor Glucose
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of CGM readings within the glucose range of 70-140 mg/dL during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of Overnight Time Below Range (<70 mg/dL)
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of CGM readings below 70 mg/dL during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of Overnight Time Below Range (<54 mg/dL)
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of CGM readings below 54 mg/dL during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of Overnight Time Above Range (>180 mg/dL)
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of CGM readings above 180 mg/dL during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of Overnight Time Above Range (>250 mg/dL)
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Percentage of CGM readings above 250 mg/dL during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Coefficient of Variation of Overnight Sensor Glucose
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Coefficient of variation of CGM glucose values during the overnight period, expressed as a percentage
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12 hours after bedtime snack consumption (21:00-09:00)
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Peak Overnight Sensor Glucose
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Highest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Nadir Overnight Sensor Glucose
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Lowest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Peak-to-Nadir Overnight Glucose Amplitude
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Difference between the highest and lowest CGM glucose concentrations during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Incremental Area Under the Overnight Glucose Curve
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Incremental area under the CGM glucose curve during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Number of Overnight Hypoglycemic Events
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Number of hypoglycemic events occurring during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Number of Overnight Hyperglycemic Events
Aikaikkuna: 12 hours after bedtime snack consumption (21:00-09:00)
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Number of hyperglycemic events occurring during the overnight period following each bedtime snack intervention.
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12 hours after bedtime snack consumption (21:00-09:00)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Torstai 19. marraskuuta 2020
Ensisijainen valmistuminen (Todellinen)
Torstai 19. marraskuuta 2020
Opintojen valmistuminen (Todellinen)
Maanantai 16. elokuuta 2021
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 13. elokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 20. elokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Perjantai 21. elokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 21. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 20. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- BEDTIME-SNACK-T1D
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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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