Person-centred nutritional education to promote a healthy Nordic diet for adults with Type 1 diabetes
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.
This project tests whether person-centred nutrition education that supports a healthy Nordic diet can improve blood sugar time-in-range in adults with Type 1 diabetes compared with brief dietary information.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Enköping, Uppland) |
| Trial ID | NCT07258758 on ClinicalTrials.gov |
What this trial studies
DINE is a single-centre, randomized parallel-group trial in Sweden that compares a person-centred nutrition education program to brief dietary information over six months. Participants randomized to the intervention receive an individual pre-assessment with a registered dietitian, an education session on the sustainable Nordic diet, and an individualized health plan; control participants receive short dietary information. All participants wear continuous glucose monitoring (CGM) throughout the trial and attend clinic visits for blood samples and clinical checks at baseline and six months. The primary outcome is change in glucose time-in-range (TIR), with secondary outcomes including blood lipids, blood pressure, and adherence to the Nordic diet; the planned enrollment is 54 participants and the trial is unblinded.
Who should consider this trial
Good fit: Adults (≥18 years) with Type 1 diabetes for >12 months, HbA1c >57 mmol/mol, using CGM and a basal-bolus insulin regimen for at least three months, who can consent and attend clinic visits.
Not a fit: People who are pregnant or planning pregnancy, have cognitive impairment or medical conditions preventing participation, have food allergies incompatible with the Nordic diet, plan changes to glucose-lowering treatment or CGM during the study, or do not use CGM/basal-bolus insulin are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could increase time spent in target glucose range and improve cardiovascular risk markers while promoting a sustainable, healthy diet for people with Type 1 diabetes.
How similar studies have performed: Dietary counseling and structured nutritional programs, including Mediterranean-style diets, have shown benefits for glycemic control and cardiovascular risk in diabetes, but person-centred Nordic diet programs in Type 1 diabetes are relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Where this trial is running
Enköping, Uppland
- Hospital of Enköping — Enköping, Uppland, Sweden (Recruiting)
Study contacts
- Principal investigator: Elisabeth Stoltz Sjöström, Associate professor — Department of Food, Nutrition and Culinary Science, Umeå University, Sweden
- Study coordinator: Sophie Rodebjer Cairns, Registered dietitian
- Email: sophie.cairns@umu.se
- Phone: +46171418551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.