Actively Recruiting
Diabetes Intervention Involving Person-centred Nutritional Education
Led by Umeå University · Updated on 2025-12-12
54
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
L
Lasarettet i Enköping
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diabetes Intervention Involving Person-centred Nutritional Education
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Type 1 diabetes
- Diabetes duration longer than 12 months at screening
- Adults aged 18 years or older
- HbA1c greater than 57 mmol/mol
- Use of continuous glucose monitoring sensor for more than three months at screening and during the study
- Use of basal and bolus insulin regimen for more than three months at screening and during the study
- Signed written informed consent
You will not qualify if you...
- Women of childbearing potential who are pregnant or planning pregnancy during the study
- Cognitive impairment or other diseases deemed incompatible by the study physician
- Planned changes in glucose-lowering treatment during the study (except mealtime insulin analogue changes with same profile)
- Planned change of continuous glucose monitoring sensor during the study
- Food allergies or intolerances preventing adherence to Nordic nutrition recommendations
- Current or planned corticosteroid treatment during the study (except replacement therapy)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital of Enköping
Enköping, Uppland, Sweden, 74525
Actively Recruiting
Research Team
S
Sophie Rodebjer Cairns, Registered dietitian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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