App-technology to Increase Physical Activity Among Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on physical activity levels and outcomes of HbA1c than usual care.

Official Title
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App-technology to Enhance Self-care for Patients With Diabetes Type 2 - A Randomized Controlled Trial

Conditions
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Exercise, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: App-technology to increase physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of type 2 diabetes 18 years of age or older Ability to communicate in Swedish Have and be able to use a smartphone Exclusion Criteria: Not being able to walk

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-technology group<br>Participants in the intervention group (App-technology) will use a newly developed smartphone application (app) in which steps are automatically measured and laboratory values from blood sampling within primary care will be shown. Intervention: App-technology to increase physical activity | Behavioral: App-technology to increase physical activity<br>* Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app.<br>|
| No Intervention: Control group<br>The control group will receive standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity level (counts/min from accelerometers) |  | baseline and month 3, 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (mmol/mol) |  | Baseline and month 3, 6 and 12 | 
| Steps/day |  | Baseline and month 3, 6 and 12 | 
| Total cholesterol (mmol/L) |  | Baseline and month 3, 6 and 12 | 
| HDL-cholesterol (mmol/L) |  | Baseline and month 3, 6 and 12 | 
| Triglycerides (mmol/L) |  | Baseline and month 3, 6 and 12 | 
| Apolipoprotein A1 (g/l) |  | Baseline and month 3, 6 and 12 | 
| Apolipoprotein B (g/l) |  | Baseline and month 3, 6 and 12 | 
| Body weight (kg) |  | Baseline and month 3, 6 and 12 | 
| Body Mass Index (BMI, kg/m2) |  | Baseline and month 3, 6 and 12 | 
| Body composition | Including: %Body Fat, Fat free mass (kg), Muscle mass (kg), Total body water (kg, %) | Baseline and month 3, 6 and 12 | 
| Waist circumference (cm) |  | Baseline and month 3, 6 and 12 | 
| Blood pressure (mmHg) |  | Baseline and month 3, 6 and 12 |