Health and lifestyle tool: Health and lifestyle tool used online
Usual care: Usual care at ordinary healthcare provider
Study 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.
Eligibility
Sex
ALL
Min age
35 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Change of long-term blood glucose concentration measured as glycated hemoglobin at 3 months — 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.
Change of long-term blood glucose concentration measured as glycated hemoglobin at one year — One year of the open-label observation period 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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