Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07258758

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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