Diabetes Intervention Involving Person-centred Nutritional Education

Recruiting now · Not applicable

Conditions studied: Diabetes Type 1

In brief

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.

Key facts

Study ID

NCT07258758

Run by

Umeå University

People needed

54

Starts

2025-09-01

Expected to finish

2027-06-01

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Hospital of Enköping — Enköping, Uppland, Sweden (enrolling)

Full record on ClinicalTrials.gov

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