Type 1 Diabetes (T1D)
Conditions
Keywords
Bedtime snack, Nocturnal glycemia, Continuous glucose monitoring, Time in range, Glycemic variability, Macronutrient composition, Multiple daily injections, Children, Adolescents
Brief summary
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.
Interventions
OTHERCarbohydrate-Only Bedtime Snack
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.
OTHERCarbohydrate-Plus-Protein Bedtime Snack
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.
OTHERCarbohydrate-Plus-Fat Bedtime Snack
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.
OTHERCarbohydrate-Plus-Fiber Bedtime Snack
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.
Sponsors
Didem Güneş Kaya
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each participant received all four bedtime snack interventions in a randomized order. Each snack condition was administered for three consecutive nights. No washout period was included because the interventions consisted of acute bedtime snacks and outcomes were assessed during the same overnight period following each snack.
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overnight Time in Range (70-180 mg/dL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Overnight Hypoglycemic Events | 12 hours after bedtime snack consumption (21:00-09:00) | Number of hypoglycemic events occurring during the overnight period following each bedtime snack intervention. |
| Number of Overnight Hyperglycemic Events | 12 hours after bedtime snack consumption (21:00-09:00) | Number of hyperglycemic events occurring during the overnight period following each bedtime snack intervention. |
| Peak Overnight Sensor Glucose | 12 hours after bedtime snack consumption (21:00-09:00) | Highest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention. |
| Nadir Overnight Sensor Glucose | 12 hours after bedtime snack consumption (21:00-09:00) | Lowest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention. |
| Peak-to-Nadir Overnight Glucose Amplitude | 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. |
| Percentage of Overnight Time Above Range (>250 mg/dL) | 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. |
| Coefficient of Variation of Overnight Sensor Glucose | 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 |
| Mean Overnight Sensor Glucose | 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. |
| Percentage of Overnight Time in Tight Range (70-140 mg/dL)vernight Sensor Glucose | 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. |
| Percentage of Overnight Time Below Range (<70 mg/dL) | 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. |
| Percentage of Overnight Time Below Range (<54 mg/dL) | 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. |
| Incremental Area Under the Overnight Glucose Curve | 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. |
| Percentage of Overnight Time Above Range (>180 mg/dL) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed