Evaluation of Lifestyle Tool in Type 2 Diabetes

NCT05679115 | Active Not Recruiting

• 1 other identifier: HealthDiabetes2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to observe the change of long-term metabolic control in patients with type 2 diabetes who have access to a digital intervention tool as compared with randomized controls during one year. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. .

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change of long-term blood glucose concentration measured as glycated hemoglobin at 1 year

  Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at 1 year relative to baseline compared between participants with access to the tool and on usual care.

  1 year

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

Participants get access to the tool and use it regularly

Behavioral: Lifestyle tool

Controls on standard care

NO INTERVENTION

Participants who get randomized to control cannot access the tool.

Interventions

Lifestyle tool BEHAVIORAL

Regular use of the digital Lifestyle tool

Lifestyle intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes at or above 35 years of age
• HbA1C at 52 mmol/mol or above
• Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication
• written informed consent.

You may not qualify if:

• type 1 diabetes, MODY or secondary diabetes
• conditions or treatments that in the judgement of the Investigator could affect the study evaluation
• connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Clinical Research Center

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Anders Rosengren, Professor

  Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 10, 2023
• Study Start: January 10, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after publication.
• Access Criteria: To researchers who provide a methodologically sound proposal in order to achieve the aims of that proposal. Proposals should be directed by email to livsstilsverktyget@gu.se

Locations

SE (1)