Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Study to Evaluate the Digital Health and Lifestyle Tool Developed at the University of Gothenburg
The overall aim of the study is to evaluate a digital lifestyle intervention that has been developed in an academic setting at the University of Gothenburg, Sweden. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. The effects of the tool on HbA1c, reflecting long-term blood glucose, will be evaluated in patients with type 2 diabetes. The study will contain two phases. The study consists of a three-month period in which participants are randomly assigned to usual care or access to the intervention tool, followed by an open-label three-year observation period during which participants have access to the tool in addition to ordinary healthcare and are compared with matched controls on usual care.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility | Inclusion Criteria: - Patients with type 2 diabetes at or above 35 years of age - Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication or diagnosed according to the WHO criteria (random plasma glucose >11.1 mmol/L or fasting glucose >7.0 mmol/L or HbA1C =6.5%). - 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 - inability to understand written Swedish - 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Clinical Research Center | Malmö | Skane |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of long-term blood glucose concentration measured as glycated hemoglobin in participants with and without Mild Obesity-related Diabetes, respectively. | As a subanalysis we will analyse the effect of the intervention specifically on patients with Mild Obesity-related Diabetes (MOD). This will be analysed by a formal interaction test between MOD and non-MOD participants exposed or not exposed to the intervention by using a linear model with a term for MOD/non-MOD, a term for the exposure/non-exposure to the intervention and an interaction term. | 1 year and 3 years | |
Primary | 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 | |
Primary | 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 | Change of long-term blood glucose concentration measured as glycated hemoglobin at three years | Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at three years relative to baseline between participants who use the tool as recommended and matched controls on usual care | Three years of the open-label observation period | |
Secondary | Body weight | Body weight between groups | 3 months, 1 year and 3 years | |
Secondary | Insulin resistance | Insulin resistance measured as HOMA-IR | 3 months, 1 year and 3 years | |
Secondary | Fasting blood glucose concentration | Fasting blood glucose concentration between groups | 3 months, 1 year and 3 years | |
Secondary | Physical activity in calories per day | Physical activity in calories per day estimated by International Physical activity questionnaire between users of the tool and controls on usual care. Score measures calorie consumption and ranges from 0 to unlimited | 3 years | |
Secondary | Insulin secretion | Insulin secretion estimated by HOMA-B | 1 year and 3 years |
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