Person-centred nutritional education to promote a healthy Nordic diet for adults with Type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.