Effects of Bedtime Snack Composition on Overnight Glucose in Children and Adolescents With Type 1 Diabetes
2026년 8월 20일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
20
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Fatih
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Istanbul, Fatih, 터키 (Türkiye), 34098
- Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
4
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
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실험적: 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.
|
|
실험적: 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.
|
|
실험적: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overnight Time in Range (70-180 mg/dL)
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Overnight Sensor Glucose
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2020년 11월 19일
기본 완료 (실제)
기본 완료
2020년 11월 19일
연구 완료 (실제)
연구 완료
2021년 8월 16일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 13일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 20일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 21일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 20일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- BEDTIME-SNACK-T1D
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .