Diabetes Intervention Involving Person-centred Nutritional Education (DINE)

December 4, 2025 updated by: Elisabeth Stoltz Sjöström, Umeå University

Diabetes Intervention Involving Person-centred Nutritional Education (DINE) - Exploring the Benefits and Challenges of a Person-centred Education on the Nordic Diet for Adults With Type 1 Diabetes.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Diabetes Intervention Involving Person-centred Nutritional Education (DINE) trial is a single-centre, randomized parallel group study conducted in Sweden. The trial aims to compare a person-centred intervention involving nutritional education with the current practice of providing short dietary information to adults with Type 1 diabetes. The study period is six months and will assess the effectiveness of the intervention in a real-world setting, rather than under controlled conditions. Due to the active involvement of participants, blinding of study personnel or participants is not possible.

To determine the sample size, a power calculation was performed using the primary endpoint, 'blood glucose time in range' (TIR). The calculation is based on a clinically relevant change in TIR (8%) from intervention to the six-month follow-up. The proposed enrolment is 54 participants to achieve sufficient power (80%) to test the primary hypothesis. Recruitment will continue until this number is reached. Assuming an 80% consent rate, we expect to enrol at least 54 participants within 12 months.

Participants in the intervention group will start with an individual pre-assessment with a registered dietitian, focusing on their preferences and values. This aims to build a partnership in care through the participant´s narrative. Next, they will attend an education session on the sustainable, healthy Nordic diet. During this session, the participant will develop an individual health plan together with the dietitian as part of shared decision-making. These handwritten plans will be copied, with one given to the participant and one kept by the dietitian for medical records.

The health plans will be reviewed twice during the study period, allowing for updates with new goals or more realistic targets. These updates will be documented by the dietitian. Participants will receive monthly text message reminders to enhance the intervention's efficacy.

Control group participants will receive short dietary information as part of routine clinical practice. The study duration for all participants is six months.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sophie Rodebjer Cairns, Registered dietitian
  • Phone Number: +46171418551
  • Email: sophie.cairns@umu.se

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Person-centred nutritional education
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
A person-centred education focussed on creating partnerships in care and shared decision-making.
No Intervention: Short dietary information
The participants in this arm will receive short dietary information (brochure) at the same level as standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range - Percentage of time spent with blood glucose levels between 3.9-10 mmol/l.
Time Frame: Week 1, 12 and 24.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to a Nordic diet.
Time Frame: Week 1 and 24.
Evaluation and analysis of diet data from Food frequency questionnaire (FFQ) and food diary.
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.
Time Frame: Week 1, 12 and 24.
Percentage of time with high blood glucose levels, measured with continuous glucose monitor over 10-14 days.
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.
Time Frame: Week 1, 12 and 24.
Percentage of time with low blood glucose levels, measured with continuous glucose monitor over 10-14 days.
Week 1, 12 and 24.
Blood lipids.
Time Frame: Week 1 and 24.
Blood lipids (total cholesterol, high-density cholesterol, low-density cholesterol, triglycerides, non-HDL cholesterol, cholesterol/HDL ratio) assessed in a clinical laboratory.
Week 1 and 24.
Glycosylated Hemoglobin (HbA1c).
Time Frame: Week 1 and 24.
HbA1c represents overall glycaemic control over the last three months.
Week 1 and 24.
Blood pressure.
Time Frame: Week 1 and 24.
Systolic and diastolic blood pressure measured at hospital clinic.
Week 1 and 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Lasarettet i Enköping

Investigators

  • Principal Investigator: Elisabeth Stoltz Sjöström, Associate professor, Department of Food, Nutrition and Culinary Science, Umeå University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-04356-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Type 1

Clinical Trials on Dietary intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe