Type1diabetesDANCENCT03761186
Comparison of Low, Moderate and High Carbohydrate Diet on Insulin Requirements and Metabolic Control in Type 1 Diabetes
A study testing traditional diabetes diet, moderately low carbohydrate diet and strictly low carbohydrate diet in people with Type1diabetes, run by Anneli Björklund at 1 site in Sweden.
Trial summary
The scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with the current recommendations being based on type 2 diabetes studies. Therefore the overall purpose of this study is to improve the current evidence for dietary recommendations to people with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- traditional diabetes diet, moderately low carbohydrate diet and strictly low carbohydrate diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSweden
- Study dates
- 12 Dec 2018to 11 Mar 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have had type 1 diabetes for at least 1 year
- Age >=20 years old
Who cannot join
- Cardiovascular disease NYHA class IIIB or more
- Kidney disease > stadium 3
- Liver disease, alanine aminotransferase (ALAT) ≥ 2 µkat/L,
- BMI < 18.5 kg/m^2
- c-peptide ≥ 0.3 nmol/l
- Pregnant/breastfeeding women, women that plan to get pregnant during study period
- Other circumstances, which, according to the examiner, make it difficult for an individual to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DANCE (Diabetes ANd CarbohydratEs). Does the Amount of Dietary Carbohydrates Affect Insulin Requirements and Metabolic Control in Type 1 Diabetes? Comparative Study of Traditional Diabetes, Moderately Low and Strictly Low Carbohydrate Diet
The scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with the current recommendations being based on type 2 diabetes studies. Therefore the overall purpose of this study is to improve the current evidence for dietary recommendations to people with type 1 diabetes.
Study aim: To compare how a strictly low carbohydrate diet, a moderately low carbohydrate diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin requirements and metabolic control in individuals with type 1 diabetes.
Read more
Carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet, 30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate diet with a minimum of 50 g carbohydrates/day. A diet with less than 50 g carbohydrates/day is usually called very low carbohydrate diet or ketogenic and will not be tested in this study.
Those who wish to participate and meet the inclusion criteria (and none of the exclusion criteria) will be randomized to one of the three diets. The duration of the intervention is 6 months after which the participants will be able to choose their own diet for another 6 months. The main study visits are at baseline (screening and study start), 3, 6, 9, and 12 months. Shorter visits will be at 3 and 6 weeks. The participants will meet with a study nurse, dietitian and doctor. They will attend two carbohydrate counting courses before the start of the intervention in order to be able to match their insulin to the amount carbohydrates they eat. Participants will receive written materials about their diets with menus and recipes for better adherence to the diet.
The primary endpoint is the change in insulin requirements within and between groups (for secondary endpoints please see relevant section). For assessing the different endpoints the participants will provide blood, urine and feces samples for lab analyses as well as register their insulin use, blood glucose, diet, physical activity and any blood ketones or hypoglycemia electronically or in written forms. Continuous/flash glucose monitoring (CGM/FGM) will be also used. Dietary assessment and adherence will be based on 3-4 day food diaries before every scheduled study visit.
- Conditions
- Type1diabetes
- Being tested
- traditional diabetes diet, moderately low carbohydrate diet, strictly low carbohydrate diet
- Keywords
- type 1 diabetes, low carbohydrate diet, randomized trial, adults, insulin, metabolic control
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional diabetes dietBehavioural
Diet with carbohydrate content 50-60% of total energy intake
moderately low carbohydrate dietBehavioural
Diet with carbohydrate content 30-40% of total energy intake
strictly low carbohydrate dietBehavioural
Diet with carbohydrate content 15-20% of total energy intake
| Study group | Role | What they receive |
|---|---|---|
| traditional diabetes diet | Active comparator | Participants in this arm will follow a diet with carbohydrate intake 50-60% of total energy intake Receives: Behavioral: traditional diabetes diet |
| moderately low carbohydrate diet | Experimental | Participants in this arm will follow a diet with carbohydrate intake 30-40% of total energy intake Receives: Behavioral: moderately low carbohydrate diet |
| strictly low carbohydrate diet | Experimental | Participants in this arm will follow a diet with carbohydrate intake 15-20% of total energy intake Receives: Behavioral: strictly low carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin use
measured in international units (IU) and percentage.
Measured: screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary outcomes (30)
Change in HbA1c
mmol/mol
Measured: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Change in concentration of total cholesterol
mmol/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Change in concentration of triglycerides
mmol/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Change in concentration of HDL-cholesterol
mmol/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Change in concentration of LDL-cholesterol
mmol/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Ratio of LDL/HDL
absolute number
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of glucagon
pmol/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Change in markers of glycemic variability (TIR, TAR, TBR, mean sensor glucose with SD, CV)
mmol/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Change in weight
kg
Measured: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Change in BMI
kg/m^2
Measured: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Change in abdominal circumference
cm
Measured: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Change in concentration of p-creatinine
micromol/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Change in estimated Glomerular Filtration Rate (eGFR)
mL/min/1,73 m2
Measured: screening, 3 months, 6 months, 9 months, 12 months
Change in microalbuminuria
morning U-Alb/Crea (mg/mmol)
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of Insulin-like Growth Factor 1 (IGF-I)
microg/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of Insulin-like Growth Factor - binding protein 1 (IGFBP-1)
microg/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of leptin
microg/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of adiponectin
mg/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of interleukin 6 (IL-6)
ng/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of high sensitivity c-Reactive Protein (Hs-CRP)
mg/L
Measured: screening, 3 months, 6 months, 9 months, 12 months
Measurement of lipopolysaccharides (LPS) activity using the Limulus Amebocyte Lysate (LAL) assay
measured in endotoxin units (EU)/ml
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of glutaredoxin 1 (GRX-1)
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of Oxidized LDL
Measured: screening, 3 months, 6 months, 9 months, 12 months
Total Antioxidant Capacity (TAC)
Measured: screening, 3 months, 6 months, 9 months, 12 months
Concentration of reactive oxygen species (ROS)
Measured: screening, 3 months, 6 months, 9 months, 12 months
Plasma metabolites assessed by untargeted liquid chromatography - mass spectrometry (LC-MS) metabolomics
Measured: screening, 3 months, 6 months, 9 months, 12 months
Score from the Short Form 36 (SF-36) questionnaire
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Score from the Well-being Questionnaire-12 (WBQ-12)
This questionnaire is designed to measure general well-being, including negative well-being, energy and positive well-being. The negative well-being scale score (range 0-12) is reversed and then summed with the Energy score (range 0-12) and Positive score (range 0-12) to produce a general well-being score (range 0-36). The higher the score the greater the sense of general well-being.
Measured: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
The DTSQ has been developed to assess patient satisfaction with diabetes treatment. The questionnaire is composed of two different factors. The first factor assesses treatment satisfaction and consists of six questions and the second factor consists of two questions, which assess the burden from hyper- and hypoglycemia. Treatment satisfaction is assessed as the sum of the scores of the six questions on the first factor (total score 36), with a higher score indicating higher treatment satisfaction.
Measured: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Time taken to complete the Trail making test A+B
The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The time taken to complete the test is used as the primary performance metric, measured in seconds and or minutes.
Measured: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start12 Dec 2018
- Primary completion14 Sep 2023
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anneli Björklund
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor-investigator, Anneli Björklund, Karolinska Institutet
- Investigators
- Anneli Björklund, MD, PhD, Principal investigator, Department of Endocrinology at Karolinska University Hospital and Academic Specialistcentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761186
- Sponsor's protocol ID
- 2018/218-31
- Acronym
- DANCE
- Status last verified
- Jul 2026
- First submitted
- 26 Nov 2018
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DANCE (Diabetes ANd CarbohydratEs). Does the Amount of Dietary Carbohydrates Affect Insulin Requirements and Metabolic Control in Type 1 Diabetes? Comparative Study of Traditional Diabetes, Moderately Low and Strictly Low Carbohydrate Diet
- ClinicalTrials.gov ID
- NCT03761186
- Acronym / sponsor ID
- DANCE / 2018/218-31
- Conditions
- Type1diabetes
- Keywords
- type 1 diabetes, low carbohydrate diet, randomized trial, adults, insulin, metabolic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Anneli BjörklundUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 3 Dec 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 scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with the current recommendations being based on type 2 diabetes studies. Therefore the overall purpose of this study is to improve the current evidence for dietary recommendations to people with type 1 diabetes.
Study aim: To compare how a strictly low carbohydrate diet, a moderately low carbohydrate diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin requirements and metabolic control in individuals with type 1 diabetes.
Carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet, 30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate diet with a minimum of 50 g carbohydrates/day. A diet with less than 50 g carbohydrates/day is usually called very low carbohydrate diet or ketogenic and will not be tested in this study.
Those who wish to participate and meet the inclusion criteria (and none of the exclusion criteria) will be randomized to one of the three diets. The duration of the intervention is 6 months after which the participants will be able to choose their own diet for another 6 months. The main study visits are at baseline (screening and study start), 3, 6, 9, and 12 months. Shorter visits will be at 3 and 6 weeks. The participants will meet with a study nurse, dietitian and doctor. They will attend two carbohydrate counting courses before the start of the intervention in order to be able to match their insulin to the amount carbohydrates they eat. Participants will receive written materials about their diets with menus and recipes for better adherence to the diet.
The primary endpoint is the change in insulin requirements within and between groups (for secondary endpoints please see relevant section). For assessing the different endpoints the participants will provide blood, urine and feces samples for lab analyses as well as register their insulin use, blood glucose, diet, physical activity and any blood ketones or hypoglycemia electronically or in written forms. Continuous/flash glucose monitoring (CGM/FGM) will be also used. Dietary assessment and adherence will be based on 3-4 day food diaries before every scheduled study visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| traditional diabetes diet | Active comparator | Behavioral: traditional diabetes dietParticipants in this arm will follow a diet with carbohydrate intake 50-60% of total energy intake |
| moderately low carbohydrate diet | Experimental | Behavioral: moderately low carbohydrate dietParticipants in this arm will follow a diet with carbohydrate intake 30-40% of total energy intake |
| strictly low carbohydrate diet | Experimental | Behavioral: strictly low carbohydrate dietParticipants in this arm will follow a diet with carbohydrate intake 15-20% of total energy intake |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To have had type 1 diabetes for at least 1 year
- Age >=20 years old
Key exclusion criteria (7 listed)
- Cardiovascular disease NYHA class IIIB or more
- Kidney disease > stadium 3
- Liver disease, alanine aminotransferase (ALAT) ≥ 2 µkat/L,
- BMI < 18.5 kg/m^2
- c-peptide ≥ 0.3 nmol/l
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 |
|---|---|---|
| traditional diabetes dietDiet with carbohydrate content 50-60% of total energy intake | Behavioural | traditional diabetes diet |
| moderately low carbohydrate dietDiet with carbohydrate content 30-40% of total energy intake | Behavioural | moderately low carbohydrate diet |
| strictly low carbohydrate dietDiet with carbohydrate content 15-20% of total energy intake | Behavioural | strictly low carbohydrate diet |
Primary outcome
Change in insulin use
Time frame: screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
measured in international units (IU) and percentage.
30 secondary outcomes
Change in HbA1c
Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Change in concentration of total cholesterol
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Change in concentration of triglycerides
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Change in concentration of HDL-cholesterol
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Change in concentration of LDL-cholesterol
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Ratio of LDL/HDL
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of glucagon
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Change in markers of glycemic variability (TIR, TAR, TBR, mean sensor glucose with SD, CV)
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Change in weight
Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Change in BMI
Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Change in abdominal circumference
Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Change in concentration of p-creatinine
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Change in estimated Glomerular Filtration Rate (eGFR)
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Change in microalbuminuria
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of Insulin-like Growth Factor 1 (IGF-I)
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of Insulin-like Growth Factor - binding protein 1 (IGFBP-1)
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of leptin
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of adiponectin
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of interleukin 6 (IL-6)
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of high sensitivity c-Reactive Protein (Hs-CRP)
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Measurement of lipopolysaccharides (LPS) activity using the Limulus Amebocyte Lysate (LAL) assay
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of glutaredoxin 1 (GRX-1)
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of Oxidized LDL
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Total Antioxidant Capacity (TAC)
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Concentration of reactive oxygen species (ROS)
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Plasma metabolites assessed by untargeted liquid chromatography - mass spectrometry (LC-MS) metabolomics
Time frame: screening, 3 months, 6 months, 9 months, 12 months
Score from the Short Form 36 (SF-36) questionnaire
Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Score from the Well-being Questionnaire-12 (WBQ-12)
Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Score from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
Time taken to complete the Trail making test A+B
Time frame: screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months
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 20 Jul 2026.
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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.
Anneli Björklund, MD, PhD principal investigator
Department of Endocrinology at Karolinska University Hospital and Academic Specialistcentrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional diabetes diet, moderately low carbohydrate diet and strictly low carbohydrate diet in people with Type1diabetes, run by Anneli Björklund 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 2 inclusion and 7 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 20 Jul 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 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?
Change in insulin use (time frame: screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months). 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 20 Jul 2026.