Diabetes Intervention Involving Person-centred Nutritional Education

NCT07258758 | Recruiting

• 1 other identifier: 2024-04356-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Type 1

Keywords

Nutritional education; Person-centred care; Nordic diet; Diabetes intervention; Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Time in range - Percentage of time spent with blood glucose levels between 3.9-10 mmol/l.

  Percentage of time spent with glucose levels between 3.9-10 mmol/l measured with continuous glucose monitor (CGM) over 10-14 days.

  Week 1, 12 and 24.

Secondary Outcomes (6)

• Adherence to a Nordic diet.

  Week 1 and 24.

• Glycosylated Hemoglobin (HbA1c).

  Week 1 and 24.

• Time above range - percentage of time spent with blood glucose levels above 10.0 mmol/L and 13.9 mmol/L respectively.

  Week 1, 12 and 24.

• Time below range - percentage of time spent with blood glucose levels below 3.9 mmol/L and 3.0 mmol/L respectively.

  Week 1, 12 and 24.

• Blood lipids.

  Week 1 and 24.

Study Arms (2)

Person-centred nutritional education

EXPERIMENTAL

The participants in this arm will attend a person-centred intervention involving a pre-assessment focused on creating partnership in care. This is followed by a nutrition education session on the healthy Nordic diet, and a series of follow-up measures.

Behavioral: Dietary intervention

Short dietary information

NO INTERVENTION

The participants in this arm will receive short dietary information (brochure) at the same level as standard care.

Interventions

Dietary intervention BEHAVIORAL

A person-centred education focussed on creating partnerships in care and shared decision-making.

Person-centred nutritional education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Umeå University: lead
• Lasarettet i Enköping: collaborator

Study Sites (1)

Hospital of Enköping

Enköping, Uppland, 74525, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Elisabeth Stoltz Sjöström, Associate professor

  Department of Food, Nutrition and Culinary Science, Umeå University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Rodebjer Cairns, Registered dietitian

CONTACT

+46171418551; sophie.cairns@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As the participants are actively involved in the education intervention, it is not possible to have a blinded trial, however each group will not receive information about the alternative group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized parallel group study

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)