Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Evaluation of the Digital Health and Lifestyle Tool
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 35 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Clinical Research Center | Malmö |
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 tool specifically on patients with Mild Obesity-related Diabetes (MOD). This will be analysed by a formal interaction test between MOD and non-MOD participants with or without access to the tool by using a linear model with a term for MOD/non-MOD, a term for access/non-access to the tool and an interaction term. | 3 months and 1 year | |
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 | Up to three years of the open-label observation period | |
Secondary | Body weight | Body weight between groups | 1 year | |
Secondary | Fat mass | Fat mass as estimated by bioimpedance | 1 year | |
Secondary | Muscle mass | Muscle mass as estimated by bioimpedance | 1 year | |
Secondary | Insulin resistance | Insulin resistance measured as Homeostatic model assessment (HOMA-IR) | 1 year | |
Secondary | Total Cholesterol concentration in plasma | Total Cholesterol concentration in plasma between groups | 1 year | |
Secondary | Low-density lipoprotein Cholesterol concentration in plasma | Low-density lipoprotein (LDL) Cholesterol concentration in plasma between groups | 1 year | |
Secondary | High-density lipoprotein Cholesterol concentration in plasma | High-density lipoprotein (HDL) concentration in plasma between groups | 1 year | |
Secondary | Triglyceride concentration in plasma | Triglyceride concentration in plasma between groups | 1 year | |
Secondary | Fasting blood glucose concentration | Fasting blood glucose concentration between groups | 1 year | |
Secondary | Systolic blood pressure | Systolic blood pressure between groups | 1 year | |
Secondary | Diastolic blood pressure | Diastolic blood pressure between groups | 1 year | |
Secondary | Quality of life estimated by 5-level European Quality-of-life (EQ-5D-5L) questionnaire score | Quality of life estimated by 5-level European Quality-of-life (EQ-5D-5L) questionnaire score between groups. Score is from 0 to 1 with 1 meaning highest quality of life | 1 year | |
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 Homeostatic model assessment (HOMA-B) | 1 year |
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