Diabetes Mellitus, Type 1COMBINE1NCT06567158
The Impact of a Moderate Carbohydrate Diet in Children With Type 1 Diabetes on Hybrid Closed-loop Therapy
A study testing Moderate carbohydrate diet and Traditional diet in people with Diabetes Mellitus, Type 1, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In the past, carbohydrate restriction was indicated as a treatment for people with type 1 diabetes when exogenous insulin was not available. Now it is mainly used as an added treatment for people with type 1 diabetes on top of standard insulin administration and glucose monitoring. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Moderate carbohydrate diet and Traditional diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 15 May 2024to 31 Dec 2025
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent (ICF) (both children/adolescents and parents)
- ≥7 and ≤17 years old at moment of ICF signature
- ≥6 months type 1 diabetes diagnosis at moment of ICF signature
- ≥3 months use of the hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
- Ability to understand, read, write and speak Dutch, French or English at moment of ICF signature
Who cannot join
- <7 or >17 years old at moment of ICF signature
- <6 months type 1 diabetes diagnosis at moment of ICF signature
- <3 months use of the advanced hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
- Any other insulin therapy than advanced hybrid closed-loop system Medtronic MiniMedTM 780G , Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
- Failure to understand, read, write or speak Dutch, French or English at moment of ICF signature
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Kristina Casteels, Prof, +3216343811, kristina.casteels@uzleuven.be
Laura Valgaerts, +3216343890, laura.valgaerts@uzleuven.be
About this study
Official title: The Impact of Carbohydrate Restriction on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using a Hybrid Closed-loop Insulin Delivery System: a Randomized Cross-over Study
In the past, carbohydrate restriction was indicated as a treatment for people with type 1 diabetes when exogenous insulin was not available. Now it is mainly used as an added treatment for people with type 1 diabetes on top of standard insulin administration and glucose monitoring. Despite previous studies, the impact of carbohydrate restriction on glycemic control and quality of life is still not clear. Furthermore, few studies exist on carbohydrate restriction in children with type 1 diabetes and combined with the use of hybrid closed-loop insulin delivery. Therefore this study will determine the impact on glycemic control and the feasability of a moderate carbohydrate diet compared to a traditional diet in children (7-17 years) with type 1 diabetes on top of using a hybrid closed-loop system. In this randomized, crossover study, 28 children will follow a moderate carbohydrate diet (four weeks) and a traditional diet (four weeks) in randomized order. With a run-in period (two weeks) prior to the first diet and a wash-out period (six weeks) between the two diets, the children will participate in the study for a total of 16 weeks. The primary endpoint is the difference of time spent in target range (defined as a sensor glucose value between 70 and 180 mg/dL) between the four-week moderate carbohydrate diet and the four-week traditional diet.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Moderate carbohydrate diet, Traditional diet
- 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.
Moderate carbohydrate dietOther
During the moderate carbohydrate diet, participants will be asked to limit his/her carbohydrate intake to no more than 30% of their total energy intake.
Traditional dietOther
During the traditional diet, participants do not follow any diet, however their carbohydrate intake must be at least 50% of their total energy intake.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet | Experimental | The group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period. Receives: Other: Moderate carbohydrate diet; Other: Traditional diet |
| Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet | Experimental | The group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period. Receives: Other: Moderate carbohydrate diet; Other: Traditional diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Difference of time spent in range (70-180 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Secondary outcomes (21)
Time in tight range
Difference of time spent in range (70-140 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time below range
Difference of time spent below range (<70 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time in level 2 hypoglycemia
Difference of time spent below range of 54 mg/dL between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time above range
Difference of time spent above range (>180 mg/dL) between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time in level 2 hyperglycemia
Difference of time spent above range of 250 mg/dL between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Hemoglobin A1c
Difference of hemoglobin A1c between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Mean blood glucose
Difference of mean blood glucose between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Glycemic variability: standard deviation and coefficient of variation
Difference of glycemic variability, in terms of standard deviation (SD) and coefficient of variation (CV) of blood glucose levels between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Daily insulin dose
Difference of insulin doses (total, basal and bolus) between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Number of severe hypoglycemic events
Difference in the frequency of severe hypoglycemic events between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Number of diabetic ketoacidosis
Difference in the frequence of diabetic ketoacidosis between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Body weight
Difference in body weight between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Body mass index
Difference in body mass index between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations)
Difference in blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations) between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Satisfaction with the diet in the context of diabetes treatment
Difference in the satisfaction with the diet (Diabetes treatment satisfaction questionnaire - DTSQs) between the moderate carbohydrate diet and the traditional diet. The DTSQs has a scale of 0-48 and a higher score is associated with a higher treatment satifaction.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Bioelectrical impedance analysis
Difference in bioelectrical impedance analysis between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Carb ratio
Difference in carb ratio between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Active insulin time
Difference in active insulin time between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Number of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL
Difference in umber of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Consumed carbohydrates
Difference in consumed carbohydrates between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Meal composition
Difference in meal composition a between the moderate carbohydrate diet and the traditional diet.
Measured: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start15 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- The study will be preceded by a screening period to check which participants are eligible for the study and a two-week run-in period during which, participants will be asked to document their eating patterns for one week in a digital food diary to base the moderate carbohydrate diet on. Participants will be randomized into two groups (1:1). One group will start at baseline with the traditional diet and after four weeks they will cross-over to the moderate carbohydrate diet for four weeks. The second group will start at baseline with the moderate carbohydrate diet and after four weeks they will crossover to the traditional diet for four weeks. Between the two diet periods there will be a wash-out period of six weeks.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina Casteels, Prof, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567158
- Sponsor's protocol ID
- S68499
- Acronym
- COMBINE1
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Carbohydrate Restriction on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using a Hybrid Closed-loop Insulin Delivery System: a Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT06567158
- Acronym / sponsor ID
- COMBINE1 / S68499
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Aug 2024 (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.
In the past, carbohydrate restriction was indicated as a treatment for people with type 1 diabetes when exogenous insulin was not available. Now it is mainly used as an added treatment for people with type 1 diabetes on top of standard insulin administration and glucose monitoring. Despite previous studies, the impact of carbohydrate restriction on glycemic control and quality of life is still not clear. Furthermore, few studies exist on carbohydrate restriction in children with type 1 diabetes and combined with the use of hybrid closed-loop insulin delivery. Therefore this study will determine the impact on glycemic control and the feasability of a moderate carbohydrate diet compared to a traditional diet in children (7-17 years) with type 1 diabetes on top of using a hybrid closed-loop system. In this randomized, crossover study, 28 children will follow a moderate carbohydrate diet (four weeks) and a traditional diet (four weeks) in randomized order. With a run-in period (two weeks) prior to the first diet and a wash-out period (six weeks) between the two diets, the children will participate in the study for a total of 16 weeks. The primary endpoint is the difference of time spent in target range (defined as a sensor glucose value between 70 and 180 mg/dL) between the four-week moderate carbohydrate diet and the four-week traditional diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be preceded by a screening period to check which participants are eligible for the study and a two-week run-in period during which, participants will be asked to document their eating patterns for one week in a digital food diary to base the moderate carbohydrate diet on. Participants will be randomized into two groups (1:1). One group will start at baseline with the traditional diet and after four weeks they will cross-over to the moderate carbohydrate diet for four weeks. The second group will start at baseline with the moderate carbohydrate diet and after four weeks they will crossover to the traditional diet for four weeks. Between the two diet periods there will be a wash-out period of six weeks.
| Arm | Type | Receives |
|---|---|---|
| Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet | Experimental | Other: Moderate carbohydrate diet, Other: Traditional dietThe group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period. |
| Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet | Experimental | Other: Moderate carbohydrate diet, Other: Traditional dietThe group that starts with the traditional diet in the first 4-week diet period. After wash-out, this group will start with the moderate carbohydrate diet in the second 4-week diet period. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Signed informed consent (ICF) (both children/adolescents and parents)
- ≥7 and ≤17 years old at moment of ICF signature
- ≥6 months type 1 diabetes diagnosis at moment of ICF signature
- ≥3 months use of the hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
- Ability to understand, read, write and speak Dutch, French or English at moment of ICF signature
Key exclusion criteria (5 listed)
- <7 or >17 years old at moment of ICF signature
- <6 months type 1 diabetes diagnosis at moment of ICF signature
- <3 months use of the advanced hybrid closed-loop system Medtronic MiniMedTM 780G, Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
- Any other insulin therapy than advanced hybrid closed-loop system Medtronic MiniMedTM 780G , Tandem t:slim X2 Control-IQTM or Mylife Ypsopump with CamAPS algorithm at moment of ICF signature
- Failure to understand, read, write or speak Dutch, French or English at moment of ICF signature
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 |
|---|---|---|
| Moderate carbohydrate dietDuring the moderate carbohydrate diet, participants will be asked to limit his/her carbohydrate intake to no more than 30% of their total energy intake. | Other | Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet, Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet |
| Traditional dietDuring the traditional diet, participants do not follow any diet, however their carbohydrate intake must be at least 50% of their total energy intake. | Other | Group 1: 1st Traditional diet, 2nd Moderate carbohydrate diet, Group 2: 1st Moderate carbohydrate diet, 2nd Traditional diet |
Primary outcome
Time in range
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Difference of time spent in range (70-180 mg/dL) between the moderate carbohydrate diet and the traditional diet.
21 secondary outcomes
Time in tight range
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time below range
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time in level 2 hypoglycemia
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time above range
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Time in level 2 hyperglycemia
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Hemoglobin A1c
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Mean blood glucose
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Glycemic variability: standard deviation and coefficient of variation
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Daily insulin dose
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Number of severe hypoglycemic events
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Number of diabetic ketoacidosis
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Body weight
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Body mass index
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Blood lipids (total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein concentrations)
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Satisfaction with the diet in the context of diabetes treatment
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Bioelectrical impedance analysis
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Carb ratio
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Active insulin time
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Number of people who use glucose target 100 mg/dL, 110 mg/dL and 120 mg/dL
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Consumed carbohydrates
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Meal composition
Time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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.
Kristina Casteels, Prof principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate carbohydrate diet and Traditional diet in people with Diabetes Mellitus, Type 1, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Casteels, Prof (+3216343811, kristina.casteels@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 4 weeks moderate carbohydrate diet and 4 weeks traditional diet). 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 22 Aug 2024.