Effects of Bedtime Snack Composition on Overnight Glucose in Children and Adolescents With Type 1 Diabetes
2026年8月20日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Fatih
-
Istanbul、Fatih、トルコ（Türkiye）、34098
- Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overnight Time in Range (70-180 mg/dL)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Overnight Sensor Glucose
時間枠：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
時間枠：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.
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12 hours after bedtime snack consumption (21:00-09:00)
|
|
Percentage of Overnight Time Below Range (<70 mg/dL)
時間枠：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)
時間枠：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)
時間枠：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)
|
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Percentage of Overnight Time Above Range (>250 mg/dL)
時間枠：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
時間枠：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)
|
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Peak Overnight Sensor Glucose
時間枠：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
時間枠：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)
|
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Peak-to-Nadir Overnight Glucose Amplitude
時間枠：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)
|
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Incremental Area Under the Overnight Glucose Curve
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年11月19日
一次修了 (実際)
2020年11月19日
研究の完了 (実際)
2021年8月16日
試験登録日
最初に提出
2026年8月13日
QC基準を満たした最初の提出物
2026年8月20日
最初の投稿 (実際)
2026年8月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月21日
QC基準を満たした最後の更新が送信されました
2026年8月20日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- BEDTIME-SNACK-T1D
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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