Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
77000 participants
INTERVENTIONAL
2021-08-16
2026-12-31
Brief Summary
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Detailed Description
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Digital health tools are increasingly incorporated into diabetes care, and have the potential to improve both behavioral and clinical outcomes on a broad basis. However, low levels of uptake, reduced user engagement over time, and low acceptance among patients, raise concerns about their effectiveness.
The objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes.
The investigators will test the hypothesis that individuals who have access to the tool get lower incidence of type 2 diabetes or in case they already have diabetes develop improved glucose control compared with control individuals. The participants will complete the Findrisc questionnaire to assess the risk for type 2 diabetes to enable analysis of individuals with different risk.
The study is an investigator-initiated single-center study conducted over three years.
The tool is web-based and used via a computer or mobile phone. It is used at each individual's preferred pace but participants are recommended to login at least every other week. Every round the participants choose a themes (out of appr. 150 possible covering e.g. food, exercise, stress, self-reflection aspects), which takes appr. 15-30 minutes to complete. Participants then reflect on the content and how it could be implemented in daily life. When returning for next round participants are asked to reflect on any changes done since last time. There is no interaction between individual participants.
There will be two primary endpoints:
1. Incidence of type 2 diabetes as measured in non-diabetic participants with different risk for type 2 diabetes (controls vs. those using the tool regularly)
2. Change of HbA1c, reflecting long-term blood glucose control, from baseline to end of follow-up in participants who have type 2 diabetes (controls vs. those using the tool regularly).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Usage of tool
Participants get access to the tool and use it regularly
Lifestyle tool
Regular use of the digital Lifestyle tool
Controls on usual care
Participants who get randomized to control cannot access the tool and get no further follow-up. Their development of type 2 diabetes or development of HbA1c is tracked via clinical registries.
No interventions assigned to this group
Interventions
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Lifestyle tool
Regular use of the digital Lifestyle tool
Eligibility Criteria
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Inclusion Criteria
* Age above 35 years
Exclusion Criteria
* 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.
35 Years
ALL
Yes
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Anders Rosengren, Prof
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
Locations
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Anders Rosengrentest
Malmo, Skåne County, Sweden
Countries
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References
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Dwibedi C, Abrahamsson B, Rosengren AH. Effect of Digital Lifestyle Management on Metabolic Control and Quality of Life in Patients with Well-Controlled Type 2 Diabetes. Diabetes Ther. 2022 Mar;13(3):423-439. doi: 10.1007/s13300-022-01214-2. Epub 2022 Feb 12.
Other Identifiers
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Lifestyle1
Identifier Type: -
Identifier Source: org_study_id
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