Diabetes Intervention Involving Person-centred Nutritional Education
NCT07258758
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. 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.
Eligibility
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).
Conditions2
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NCT07258758