Effects of Bedtime Snack Composition on Overnight Glucose in Children and Adolescents With Type 1 Diabetes
20 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Fatih
-
Istanbul, Fatih, Turquía (Türkiye), 34098
- Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overnight Time in Range (70-180 mg/dL)
Periodo de tiempo: 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.
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12 hours after bedtime snack consumption (21:00-09:00)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Overnight Sensor Glucose
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de noviembre de 2020
Finalización primaria (Actual)
19 de noviembre de 2020
Finalización del estudio (Actual)
16 de agosto de 2021
Fechas de registro del estudio
Enviado por primera vez
13 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
21 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BEDTIME-SNACK-T1D
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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