Type 1 Diabetes (T1D)NCT07778147
Effects of Bedtime Snack Composition on Overnight Glucose in Children and Adolescents With Type 1 Diabetes
A study testing Carbohydrate-Only Bedtime Snack, Carbohydrate-Plus-Protein Bedtime Snack and Carbohydrate-Plus-Fat Bedtime Snack in people with Type 1 Diabetes (T1D), run by Didem Güneş Kaya at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Carbohydrate-Only Bedtime Snack, Carbohydrate-Plus-Protein Bedtime Snack and Carbohydrate-Plus-Fat Bedtime Snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2020to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa-Cerrahpasa Faculty of Medicine
Istanbul, Fatih, 34098
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Carbohydrate-Only Bedtime Snack, Carbohydrate-Plus-Protein Bedtime Snack, Carbohydrate-Plus-Fat Bedtime Snack, Carbohydrate-Plus-Fiber Bedtime Snack
- Keywords
- Bedtime snack, Nocturnal glycemia, Continuous glucose monitoring, Time in range, Glycemic variability, Macronutrient composition, Multiple daily injections, Children, Adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate-Only Bedtime SnackOther
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.
Carbohydrate-Plus-Protein Bedtime SnackOther
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.
Carbohydrate-Plus-Fat Bedtime SnackOther
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.
Carbohydrate-Plus-Fiber Bedtime SnackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: CHO First | Experimental | Participants received the four bedtime snack interventions in the following order: CHO, CHO+PRO, CHO+FAT, and CHO+FIB. Receives: Other: Carbohydrate-Only Bedtime Snack; Other: Carbohydrate-Plus-Protein Bedtime Snack; Other: Carbohydrate-Plus-Fat Bedtime Snack; Other: Carbohydrate-Plus-Fiber Bedtime Snack |
| Sequence 2: CHO+PRO First | Experimental | Participants received the four bedtime snack interventions in the following order: CHO+PRO, CHO+FAT, CHO+FIB, and CHO. Receives: Other: Carbohydrate-Only Bedtime Snack; Other: Carbohydrate-Plus-Protein Bedtime Snack; Other: Carbohydrate-Plus-Fat Bedtime Snack; Other: Carbohydrate-Plus-Fiber Bedtime Snack |
| Sequence 3: CHO+FAT First | Experimental | Participants received the four bedtime snack interventions in the following order: CHO+FAT, CHO+FIB, CHO, and CHO+PRO. Receives: Other: Carbohydrate-Only Bedtime Snack; Other: Carbohydrate-Plus-Protein Bedtime Snack; Other: Carbohydrate-Plus-Fat Bedtime Snack; Other: Carbohydrate-Plus-Fiber Bedtime Snack |
| Sequence 4: CHO+FIB First | Experimental | Participants received the four bedtime snack interventions in the following order: CHO+FIB, CHO, CHO+PRO, and CHO+FAT. Receives: Other: Carbohydrate-Only Bedtime Snack; Other: Carbohydrate-Plus-Protein Bedtime Snack; Other: Carbohydrate-Plus-Fat Bedtime Snack; Other: Carbohydrate-Plus-Fiber Bedtime Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overnight Time in Range (70-180 mg/dL)
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.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Secondary outcomes (13)
Mean Overnight Sensor Glucose
Mean continuous glucose monitoring (CGM) glucose concentration during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time in Tight Range (70-140 mg/dL)vernight Sensor Glucose
Percentage of CGM readings within the glucose range of 70-140 mg/dL during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time Below Range (<70 mg/dL)
Percentage of CGM readings below 70 mg/dL during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time Below Range (<54 mg/dL)
Percentage of CGM readings below 54 mg/dL during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time Above Range (>180 mg/dL)
Percentage of CGM readings above 180 mg/dL during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time Above Range (>250 mg/dL)
Percentage of CGM readings above 250 mg/dL during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Coefficient of Variation of Overnight Sensor Glucose
Coefficient of variation of CGM glucose values during the overnight period, expressed as a percentage
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Peak Overnight Sensor Glucose
Highest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Nadir Overnight Sensor Glucose
Lowest CGM glucose concentration recorded during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Peak-to-Nadir Overnight Glucose Amplitude
Difference between the highest and lowest CGM glucose concentrations during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Incremental Area Under the Overnight Glucose Curve
Incremental area under the CGM glucose curve during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Number of Overnight Hypoglycemic Events
Number of hypoglycemic events occurring during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Number of Overnight Hyperglycemic Events
Number of hyperglycemic events occurring during the overnight period following each bedtime snack intervention.
Measured: 12 hours after bedtime snack consumption (21:00-09:00)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start19 Nov 2020
- Primary completion19 Nov 2020
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Didem Güneş Kaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Didem Güneş Kaya, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778147
- Sponsor's protocol ID
- BEDTIME-SNACK-T1D
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedtime Snack Composition and Overnight Glycemic Profiles in Children and Adolescents With Type 1 Diabetes Using Multiple Daily Injections: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07778147
- Acronym / sponsor ID
- BEDTIME-SNACK-T1D
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Bedtime snack, Nocturnal glycemia, Continuous glucose monitoring, Time in range, Glycemic variability, Macronutrient composition, Multiple daily injections, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Didem Güneş KayaUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: CHO First | Experimental | Other: Carbohydrate-Only Bedtime Snack, Other: Carbohydrate-Plus-Protein Bedtime Snack, Other: Carbohydrate-Plus-Fat Bedtime Snack, Other: Carbohydrate-Plus-Fiber Bedtime SnackParticipants received the four bedtime snack interventions in the following order: CHO, CHO+PRO, CHO+FAT, and CHO+FIB. |
| Sequence 2: CHO+PRO First | Experimental | Other: Carbohydrate-Only Bedtime Snack, Other: Carbohydrate-Plus-Protein Bedtime Snack, Other: Carbohydrate-Plus-Fat Bedtime Snack, Other: Carbohydrate-Plus-Fiber Bedtime SnackParticipants received the four bedtime snack interventions in the following order: CHO+PRO, CHO+FAT, CHO+FIB, and CHO. |
| Sequence 3: CHO+FAT First | Experimental | Other: Carbohydrate-Only Bedtime Snack, Other: Carbohydrate-Plus-Protein Bedtime Snack, Other: Carbohydrate-Plus-Fat Bedtime Snack, Other: Carbohydrate-Plus-Fiber Bedtime SnackParticipants received the four bedtime snack interventions in the following order: CHO+FAT, CHO+FIB, CHO, and CHO+PRO. |
| Sequence 4: CHO+FIB First | Experimental | Other: Carbohydrate-Only Bedtime Snack, Other: Carbohydrate-Plus-Protein Bedtime Snack, Other: Carbohydrate-Plus-Fat Bedtime Snack, Other: Carbohydrate-Plus-Fiber Bedtime SnackParticipants received the four bedtime snack interventions in the following order: CHO+FIB, CHO, CHO+PRO, and CHO+FAT. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate-Only Bedtime SnackParticipants 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. | Other | Sequence 1: CHO First, Sequence 2: CHO+PRO First, Sequence 3: CHO+FAT First, Sequence 4: CHO+FIB First |
| Carbohydrate-Plus-Protein Bedtime SnackParticipants 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. | Other | Sequence 1: CHO First, Sequence 2: CHO+PRO First, Sequence 3: CHO+FAT First, Sequence 4: CHO+FIB First |
| Carbohydrate-Plus-Fat Bedtime SnackParticipants 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. | Other | Sequence 1: CHO First, Sequence 2: CHO+PRO First, Sequence 3: CHO+FAT First, Sequence 4: CHO+FIB First |
| Carbohydrate-Plus-Fiber Bedtime SnackParticipants 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. | Other | Sequence 1: CHO First, Sequence 2: CHO+PRO First, Sequence 3: CHO+FAT First, Sequence 4: CHO+FIB First |
Primary outcome
Overnight Time in Range (70-180 mg/dL)
Time frame: 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.
13 secondary outcomes
Mean Overnight Sensor Glucose
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time in Tight Range (70-140 mg/dL)vernight Sensor Glucose
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time Below Range (<70 mg/dL)
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time Below Range (<54 mg/dL)
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time Above Range (>180 mg/dL)
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Percentage of Overnight Time Above Range (>250 mg/dL)
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Coefficient of Variation of Overnight Sensor Glucose
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Peak Overnight Sensor Glucose
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Nadir Overnight Sensor Glucose
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Peak-to-Nadir Overnight Glucose Amplitude
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Incremental Area Under the Overnight Glucose Curve
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Number of Overnight Hypoglycemic Events
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Number of Overnight Hyperglycemic Events
Time frame: 12 hours after bedtime snack consumption (21:00-09:00)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate-Only Bedtime Snack, Carbohydrate-Plus-Protein Bedtime Snack and Carbohydrate-Plus-Fat Bedtime Snack in people with Type 1 Diabetes (T1D), run by Didem Güneş Kaya at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overnight Time in Range (70-180 mg/dL) (time frame: 12 hours after bedtime snack consumption (21:00-09:00)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.