Evaluation of Health and Lifestyle Tool
Evaluation of the Digital Health and Lifestyle Tool
1 other identifier
observational
300
1 country
1
Brief Summary
The overall aim of the study is to observe the natural pattern of usage and metabolic outcomes in patients with type 2 diabetes who had access to the new digital tool as a stand-alone support in addition to usual care. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. The changes in HbA1c, reflecting long-term blood glucose, will be evaluated in patients with type 2 diabetes. Patients are compared to controls on usual care not exposed to the tool.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 16, 2025
July 1, 2025
10 years
December 30, 2020
July 13, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change of long-term blood glucose concentration measured as glycated hemoglobin at 3 months
Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at 3 months relative to baseline compared between participants with access to the tool and on usual care.
3 months
Change of long-term blood glucose concentration measured as glycated hemoglobin at one year
Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at one year relative to baseline between participants who use the tool as recommended and matched controls on usual care
One year of the open-label observation period
Secondary Outcomes (15)
Change of long-term blood glucose concentration measured as glycated hemoglobin at three years
Up to three years of the open-label observation period
Body weight
1 year
Fat mass
1 year
Muscle mass
1 year
Insulin resistance
1 year
- +10 more secondary outcomes
Other Outcomes (1)
Change of long-term blood glucose concentration measured as glycated hemoglobin in participants with and without Mild Obesity-related Diabetes, respectively.
3 months and 1 year
Study Arms (2)
Access to tool
Access to the digital tool. Participants use the tool at their own in addition to usual care and do the different themes that are available. They are recommended to use it at least every other week.
No access to tool
Participants are followed by their ordinary healthcare provider and are not exposed to the tool.
Interventions
Eligibility Criteria
Individuals with type 2 diabetes, independent of disease duration or treatment
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Clinical Research Center
Malmo, 20502, Sweden
Related Publications (1)
Dwibedi C, Mellergard E, Gyllensten AC, Nilsson K, Axelsson AS, Backman M, Sahlgren M, Friend SH, Persson S, Franzen S, Abrahamsson B, Carlsson KS, Rosengren AH. Effect of self-managed lifestyle treatment on glycemic control in patients with type 2 diabetes. NPJ Digit Med. 2022 May 11;5(1):60. doi: 10.1038/s41746-022-00606-9.
PMID: 35545657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Rosengren, Prof
Region Skåne
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2020
First Posted
December 31, 2020
Study Start
January 1, 2017
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 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 internetverktyg@gu.se
Individual participant data that underlie the results will be shared after deidentification.