Diabetes Type 1DINENCT07258758
Diabetes Intervention Involving Person-centred Nutritional Education
A study testing Dietary intervention in people with Diabetes Type 1, run by Umeå University at 1 site in Sweden.
Trial summary
The overall objective for this project is to evaluate the effects of a person-centred education intervention to promote a healthy, sustainable Nordic diet compared with the current practice of providing short dietary information on health outcomes of adults with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 1
- What is being tested?
- Dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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.
- Diabetes duration for more than 12 months at screening.
- Adults 18 years or older.
- HbA1c more than 57mmol/mol.
- Use of continuous glucose monitoring (CGM) sensor for more than three months at screening and during the study period.
- Use of basal and bolus insulin regimen for more than three months at screening and during the study period.
- Written Informed Consent.
Who cannot join
- Women of childbearing potential: ongoing pregnancy or planned pregnancy during the study period.
- Cognitive impairment or other disease that study physician find non-compatible with participation.
- Planned change in glucose lowering treatment during study period (change of mealtime insulin analogue with same pharmacodynamic profile allowed).
- Planned change of CGM sensor during the study.
- Food allergies or intolerances that are incompatible with adhering to Nordic nutrition recommendations.
- Current or planned treatment with corticosteroids during the study (other than for replacement therapy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Hospital of Enköping
Enköping, Uppland, 74525
Sophie Rodebjer Cairns, Registered dietitian, +46171418551, sophie.rodebjer@regionuppsala.se
elisabeth.stoltz.sjostrom@umu.se
About this study
Official title: Diabetes Intervention Involving Person-centred Nutritional Education (DINE) - Exploring the Benefits and Challenges of a Person-centred Education on the Nordic Diet for Adults With Type 1 Diabetes.
The overall objective for this project is to evaluate the effects of a person-centred education intervention to promote a healthy, sustainable Nordic diet compared with the current practice of providing short dietary information on health outcomes of adults with Type 1 diabetes. The study will measure the intervention's impact on blood glucose levels, blood lipids, blood pressure, and adherence to a sustainable and healthy Nordic diet.
The main question the trial aims to answer is:
Read more
Does a person-centred nutritional education have an impact on glucose time in range for adults with Type 1 diabetes, compared with short dietary information?
The participants will:
- Attend either a person-centred nutrition education (intervention) or receive short dietary information (control group).
- Wear their sensor for continuous glucose monitoring (CGM) throughout the trial.
- Visit the clinic for data collection (blood samples and clinical checks) at the start and end of the trial.
- Keep a four-day food diary, fill out a food frequency questionnaire (FFQ) and estimate their food enjoyment at the start and end of the trial.
Read the detailed description
The Diabetes Intervention Involving Person-centred Nutritional Education (DINE) trial is a single-centre, randomized parallel group study conducted in Sweden. The trial aims to compare a person-centred intervention involving nutritional education with the current practice of providing short dietary information to adults with Type 1 diabetes. The study period is six months and will assess the effectiveness of the intervention in a real-world setting, rather than under controlled conditions. Due to the active involvement of participants, blinding of study personnel or participants is not possible.
To determine the sample size, a power calculation was performed using the primary endpoint, 'blood glucose time in range' (TIR). The calculation is based on a clinically relevant change in TIR (8%) from intervention to the six-month follow-up. The proposed enrolment is 54 participants to achieve sufficient power (80%) to test the primary hypothesis. Recruitment will continue until this number is reached. Assuming an 80% consent rate, we expect to enrol at least 54 participants within 12 months.
Participants in the intervention group will start with an individual pre-assessment with a registered dietitian, focusing on their preferences and values. This aims to build a partnership in care through the participant´s narrative. Next, they will attend an education session on the sustainable, healthy Nordic diet. During this session, the participant will develop an individual health plan together with the dietitian as part of shared decision-making. These handwritten plans will be copied, with one given to the participant and one kept by the dietitian for medical records.
The health plans will be reviewed twice during the study period, allowing for updates with new goals or more realistic targets. These updates will be documented by the dietitian. Participants will receive monthly text message reminders to enhance the intervention's efficacy.
Control group participants will receive short dietary information as part of routine clinical practice. The study duration for all participants is six months.
- Conditions
- Diabetes Type 1
- Being tested
- Dietary intervention
- Keywords
- Nutritional education, Person-centred care, Nordic diet, Diabetes intervention, Type 1 Diabetes
- 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.
Dietary interventionBehavioural
A person-centred education focussed on creating partnerships in care and shared decision-making.
| Study group | Role | What they receive |
|---|---|---|
| Person-centred nutritional education | Experimental | The participants in this arm will attend a person-centred intervention involving a pre-assessment focused on creating partnership in care. This is followed by a nutrition education session on the healthy Nordic diet, and a series of follow-up measures. Receives: Behavioral: Dietary intervention |
| Short dietary information | No intervention | The participants in this arm will receive short dietary information (brochure) at the same level as standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range - Percentage of time spent with blood glucose levels between 3.9-10 mmol/l.
Percentage of time spent with glucose levels between 3.9-10 mmol/l measured with continuous glucose monitor (CGM) over 10-14 days.
Measured: Week 1, 12 and 24.
Secondary outcomes (6)
Adherence to a Nordic diet.
Evaluation and analysis of diet data from Food frequency questionnaire (FFQ) and food diary.
Measured: Week 1 and 24.
Glycosylated Hemoglobin (HbA1c).
HbA1c represents overall glycaemic control over the last three months.
Measured: Week 1 and 24.
Time above range - percentage of time spent with blood glucose levels above 10.0 mmol/L and 13.9 mmol/L respectively.
Percentage of time with high blood glucose levels, measured with continuous glucose monitor over 10-14 days.
Measured: Week 1, 12 and 24.
Time below range - percentage of time spent with blood glucose levels below 3.9 mmol/L and 3.0 mmol/L respectively.
Percentage of time with low blood glucose levels, measured with continuous glucose monitor over 10-14 days.
Measured: Week 1, 12 and 24.
Blood lipids.
Blood lipids (total cholesterol, high-density cholesterol, low-density cholesterol, triglycerides, non-HDL cholesterol, cholesterol/HDL ratio) assessed in a clinical laboratory.
Measured: Week 1 and 24.
Blood pressure.
Systolic and diastolic blood pressure measured at hospital clinic.
Measured: Week 1 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Parallel groups
- Model description
- Randomized parallel group study
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Lasarettet i Enköping
- Responsible party
- Principal investigator, Elisabeth Stoltz Sjöström, Umeå University
- Investigators
- Elisabeth Stoltz Sjöström, Associate professor, Principal investigator, Department of Food, Nutrition and Culinary Science, Umeå University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258758
- Sponsor's protocol ID
- 2024-04356-01
- Acronym
- DINE
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Intervention Involving Person-centred Nutritional Education (DINE) - Exploring the Benefits and Challenges of a Person-centred Education on the Nordic Diet for Adults With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT07258758
- Acronym / sponsor ID
- DINE / 2024-04356-01
- Conditions
- Diabetes Type 1
- Keywords
- Nutritional education, Person-centred care, Nordic diet, Diabetes intervention, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Lasarettet i Enköping
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Dec 2025 (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 overall objective for this project is to evaluate the effects of a person-centred education intervention to promote a healthy, sustainable Nordic diet compared with the current practice of providing short dietary information on health outcomes of adults with Type 1 diabetes. The study will measure the intervention's impact on blood glucose levels, blood lipids, blood pressure, and adherence to a sustainable and healthy Nordic diet.
The main question the trial aims to answer is:
Does a person-centred nutritional education have an impact on glucose time in range for adults with Type 1 diabetes, compared with short dietary information?
The participants will:
- Attend either a person-centred nutrition education (intervention) or receive short dietary information (control group).
- Wear their sensor for continuous glucose monitoring (CGM) throughout the trial.
- Visit the clinic for data collection (blood samples and clinical checks) at the start and end of the trial.
- Keep a four-day food diary, fill out a food frequency questionnaire (FFQ) and estimate their food enjoyment at the start and end of the trial.
Detailed description
The Diabetes Intervention Involving Person-centred Nutritional Education (DINE) trial is a single-centre, randomized parallel group study conducted in Sweden. The trial aims to compare a person-centred intervention involving nutritional education with the current practice of providing short dietary information to adults with Type 1 diabetes. The study period is six months and will assess the effectiveness of the intervention in a real-world setting, rather than under controlled conditions. Due to the active involvement of participants, blinding of study personnel or participants is not possible.
To determine the sample size, a power calculation was performed using the primary endpoint, 'blood glucose time in range' (TIR). The calculation is based on a clinically relevant change in TIR (8%) from intervention to the six-month follow-up. The proposed enrolment is 54 participants to achieve sufficient power (80%) to test the primary hypothesis. Recruitment will continue until this number is reached. Assuming an 80% consent rate, we expect to enrol at least 54 participants within 12 months.
Participants in the intervention group will start with an individual pre-assessment with a registered dietitian, focusing on their preferences and values. This aims to build a partnership in care through the participant´s narrative. Next, they will attend an education session on the sustainable, healthy Nordic diet. During this session, the participant will develop an individual health plan together with the dietitian as part of shared decision-making. These handwritten plans will be copied, with one given to the participant and one kept by the dietitian for medical records.
The health plans will be reviewed twice during the study period, allowing for updates with new goals or more realistic targets. These updates will be documented by the dietitian. Participants will receive monthly text message reminders to enhance the intervention's efficacy.
Control group participants will receive short dietary information as part of routine clinical practice. The study duration for all participants is six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized parallel group study
| Arm | Type | Receives |
|---|---|---|
| Person-centred nutritional education | Experimental | Behavioral: Dietary interventionThe participants in this arm will attend a person-centred intervention involving a pre-assessment focused on creating partnership in care. This is followed by a nutrition education session on the healthy Nordic diet, and a series of follow-up measures. |
| Short dietary information | No intervention | –The participants in this arm will receive short dietary information (brochure) at the same level as standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 1 Diabetes.
- Diabetes duration for more than 12 months at screening.
- Adults 18 years or older.
- HbA1c more than 57mmol/mol.
- Use of continuous glucose monitoring (CGM) sensor for more than three months at screening and during the study period.
Key exclusion criteria (6 listed)
- Women of childbearing potential: ongoing pregnancy or planned pregnancy during the study period.
- Cognitive impairment or other disease that study physician find non-compatible with participation.
- Planned change in glucose lowering treatment during study period (change of mealtime insulin analogue with same pharmacodynamic profile allowed).
- Planned change of CGM sensor during the study.
- Food allergies or intolerances that are incompatible with adhering to Nordic nutrition recommendations.
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 |
|---|---|---|
| Dietary interventionA person-centred education focussed on creating partnerships in care and shared decision-making. | Behavioural | Person-centred nutritional education |
Primary outcome
Time in range - Percentage of time spent with blood glucose levels between 3.9-10 mmol/l.
Time frame: Week 1, 12 and 24.
Percentage of time spent with glucose levels between 3.9-10 mmol/l measured with continuous glucose monitor (CGM) over 10-14 days.
6 secondary outcomes
Adherence to a Nordic diet.
Time frame: Week 1 and 24.
Glycosylated Hemoglobin (HbA1c).
Time frame: Week 1 and 24.
Time above range - percentage of time spent with blood glucose levels above 10.0 mmol/L and 13.9 mmol/L respectively.
Time frame: Week 1, 12 and 24.
Time below range - percentage of time spent with blood glucose levels below 3.9 mmol/L and 3.0 mmol/L respectively.
Time frame: Week 1, 12 and 24.
Blood lipids.
Time frame: Week 1 and 24.
Blood pressure.
Time frame: Week 1 and 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Elisabeth Stoltz Sjöström, Associate professor principal investigator
Department of Food, Nutrition and Culinary Science, Umeå University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Diabetes Type 1, run by Umeå University 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 7 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: looking for participants now, as of the sponsor's last update on 12 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Rodebjer Cairns, Registered dietitian (+46171418551, sophie.cairns@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range - Percentage of time spent with blood glucose levels between 3.9-10 mmol/l. (time frame: Week 1, 12 and 24.). 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 12 Dec 2025.