Effects of Bedtime Snack Composition on Overnight Glucose in Children and Adolescents With Type 1 Diabetes
20 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Fatih
-
Istanbul, Fatih, Turquia (Türkiye), 34098
- Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overnight Time in Range (70-180 mg/dL)
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Overnight Sensor Glucose
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de novembro de 2020
Conclusão Primária (Real)
19 de novembro de 2020
Conclusão do estudo (Real)
16 de agosto de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
13 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de agosto de 2026
Primeira postagem (Real)
21 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BEDTIME-SNACK-T1D
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .