Diabetes Mellitus, Type 1NCT03400618
Carbohydrate Content in the Diet in Type 1 Diabetes
A study testing Moderate carbohydrate diet and Higher carbohydrate diet in people with Diabetes Mellitus, Type 1, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The aim of this study is to analyse the effect of a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Moderate carbohydrate diet and Higher carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2018to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Adults 18 years or older
- Written Informed Consent
- HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)
Who cannot join
- Pregnancy or planned pregnancy for the study duration
- Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion
- Problems with compliance to the intervention diets (excluding a lot of the foods that are common in the diets like wholegrain/beans/lentils/fruit/vegetables) because of personal preferences, other diseases, stomach problems etc.
- Diabetes duration < 1 year
- Planned change in diabetes treatment (eg. Start with insulin pump, CGM etc.) during the study period
- Other investigator-determined criteria unsuitable for patient participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes
The aim of this study is to analyse the effect of a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded continuous glucose monitoring (CGM).
The trial has a cross-over design and 12 weeks in duration, where patients will be randomized to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be healthy and planned by a dietitian. There will be 50 subjects included in the study.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Moderate carbohydrate diet, Higher carbohydrate diet
- Keywords
- Carbohydrates, Diet, Diabetes Mellitus, Type 1
- 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
30 E % carbohydrates included in the diet
Higher carbohydrate dietOther
50 E % carbohydrates included in the diet
| Study group | Role | What they receive |
|---|---|---|
| Moderate carbohydrate diet | Experimental | A healthy diet containing 30 E % carbohydrates Receives: Other: Moderate carbohydrate diet |
| Higher carbohydrate diet | Experimental | A healthy diet containing 50 E % carbohydrates Receives: Other: Higher carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in mean glucose level
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Measured: Week 3-4, week 11-12
Secondary outcomes (12)
The difference in standard deviation of glucose levels
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Measured: Week 3-4, week 11-12
The difference in the proportion of time with high glucose levels
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Measured: Week 3-4, week 11-12
The difference in the proportion of time with euglycaemic levels
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Measured: Week 3-4, week 11-12
Weight
The difference in weight between week 4 and week 12
Measured: Week 4, week 12
Total cholesterol
The difference in total cholesterol between week 4 and week 12
Measured: Week 4, week 12
LDL cholesterol
The difference in LDL cholesterol between week 4 and week 12
Measured: Week 4, week 12
HDL cholesterol
The difference in HDL cholesterol between week 4 and week 12
Measured: Week 4, week 12
Triglycerides
The difference in triglycerides between week 4 and week 12
Measured: Week 4, week 12
Total insulin dose
The difference in total insulin dose between week 1-4 and week 9-12
Measured: Week 1-4, week 9-12
Diabetes Treatment Satisfaction Questionnaire (DTSQc) score
The difference in DTSQc score at week 12
Measured: Week 12
Diabetes Treatment Satisfaction Questionnaire (DTSQs) score
The difference in DTSQs scores between week 4 and week 12
Measured: Week 4, week 12
Hypoglycemia confidence score
The difference in hypoglycaemia confidence scores between week 4 and week 12
Measured: Week 4, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marcus Lind, PhD, Principal investigator, NU Hospital Organization/University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400618
- Sponsor's protocol ID
- Carbohydrate study
- Status last verified
- Apr 2023
- First submitted
- 5 Jan 2018
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sterner Isaksson S, Olafsdottir AF, Lind M. Design of a randomized cross-over study evaluating effects of carbohydrate intake on glycemic control in persons with type 1 diabetes. Front Nutr. 2023 Mar 13;10:1114317. doi: 10.3389/fnut.2023.1114317. eCollection 2023.
PubMed 36992911
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03400618
- Acronym / sponsor ID
- Carbohydrate study
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Carbohydrates, Diet, Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Jan 2018 (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.
The aim of this study is to analyse the effect of a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded continuous glucose monitoring (CGM).
The trial has a cross-over design and 12 weeks in duration, where patients will be randomized to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be healthy and planned by a dietitian. There will be 50 subjects included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate carbohydrate diet | Experimental | Other: Moderate carbohydrate dietA healthy diet containing 30 E % carbohydrates |
| Higher carbohydrate diet | Experimental | Other: Higher carbohydrate dietA healthy diet containing 50 E % carbohydrates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes
- Adults 18 years or older
- Written Informed Consent
- HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)
Key exclusion criteria (6 listed)
- Pregnancy or planned pregnancy for the study duration
- Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion
- Problems with compliance to the intervention diets (excluding a lot of the foods that are common in the diets like wholegrain/beans/lentils/fruit/vegetables) because of personal preferences, other diseases, stomach problems etc.
- Diabetes duration < 1 year
- Planned change in diabetes treatment (eg. Start with insulin pump, CGM etc.) during the study period
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 diet30 E % carbohydrates included in the diet | Other | Moderate carbohydrate diet |
| Higher carbohydrate diet50 E % carbohydrates included in the diet | Other | Higher carbohydrate diet |
Primary outcome
The difference in mean glucose level
Time frame: Week 3-4, week 11-12
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
12 secondary outcomes
The difference in standard deviation of glucose levels
Time frame: Week 3-4, week 11-12
The difference in the proportion of time with high glucose levels
Time frame: Week 3-4, week 11-12
The difference in the proportion of time with euglycaemic levels
Time frame: Week 3-4, week 11-12
Weight
Time frame: Week 4, week 12
Total cholesterol
Time frame: Week 4, week 12
LDL cholesterol
Time frame: Week 4, week 12
HDL cholesterol
Time frame: Week 4, week 12
Triglycerides
Time frame: Week 4, week 12
Total insulin dose
Time frame: Week 1-4, week 9-12
Diabetes Treatment Satisfaction Questionnaire (DTSQc) score
Time frame: Week 12
Diabetes Treatment Satisfaction Questionnaire (DTSQs) score
Time frame: Week 4, week 12
Hypoglycemia confidence score
Time frame: Week 4, week 12
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 26 Apr 2023.
- Derived from this study: PubMed 36992911Sterner Isaksson S, Olafsdottir AF, Lind M. Design of a randomized cross-over study evaluating effects of carbohydrate intake on glycemic control in persons with type 1 diabetes. Front Nutr. 2023 Mar 13;10:1114317. doi: 10.3389/fnut.2023.1114317. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 1
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Marcus Lind, PhD principal investigator
NU Hospital Organization/University of Gothenburg
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 Higher carbohydrate diet in people with Diabetes Mellitus, Type 1, run by Vastra Gotaland Region at 1 site in Sweden.
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 4 inclusion and 6 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 26 Apr 2023. 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 Sweden. 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?
The difference in mean glucose level (time frame: Week 3-4, week 11-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400618, which also lists 1 linked publication.
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 26 Apr 2023.