Outcomes-Based Health Program for Type 2 Diabetes
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-74
SponsorKuopio University Hospital
About this trial
Type 2 diabetes is a growing health concern worldwide, influenced by genetic factors, overweight, metabolic syndrome, and insufficient physical activity. Good treatment and glycemic control can reduce or delay diabetes-related complications, which account for a significant and increasing share of healthcare costs in Finland. Much of this cost growth is due to complications resulting from inadequate diabetes care. Secondary prevention programs can therefore provide both health and economic benefits. Lifestyle interventions are one way to improve type 2 diabetes care and reduce complications.
This study aims to evaluate the impact of a digital lifestyle intervention combined with optimized care on treatment and outcomes among adults with type 2 diabetes at high risk for complications.
The intervention includes access to the BitHabit "Small Actions" application, which supports healthy lifestyle changes, and for participants with a body mass index (BMI) over 30, the Onnikka weight management application. The study will be conducted in North Savo, Finland, using a case-control design. Approximately 120 participants will receive the intervention and 50-100 will serve as controls. All participants will have their care plans reviewed and updated according to the Finnish Current Care Guidelines for Type 2 Diabetes. Control group participants will receive standard care, while the intervention group will receive standard care plus the digital tools. The study also includes the validation of the PAID (Problem Areas in Diabetes) questionnaire for use in Finland and in the Finnish language.
The study duration for each participant is 12 months. Data will be collected through physiological measurements, laboratory tests, questionnaires, and app usage logs. Measurements and questionnaires will be conducted at baseline and after 12 months. The analyses will describe the phenomenon, its prevalence, and associations between variables, as well as potential dependencies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Type 2 diabetes diagnosed
diagnosed coronary artery disease,
diagnosed periferal artery disease,
diagnosed heart failure,
Disqualifiers
eGFR < 30
uACR > 200
BMI > 50
heart ejection fraction EF < 30
Trial design
Design model
Parallel
Treatments tested in this trial
BitHabit digital application for behavioral lifestyle changes
Other interventionBitHabit digital application for behavioral lifestyle changes
Onnikka weight management digital application
Other interventionOnnikka weight management digital application
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Digital intervention armExperimental treatment 2 interventions
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in weight at 12 months
Change from baseline in weight at 12 months. Weight measurement is taken by study nurse both at baseline and at the end of the study.
Time frame
From enrollment to the end of follow-up at 12 months2
Change from baseline in BMI at 12 months
Change from baseline in BMI at 12 months. Weight and height measurement are taken by study nurse both at baseline and at the end of the study.
Time frame
From enrollment to the end of follow-up at 12 months3
Change from baseline in waist circumference at 12 months
Change from baseline in waist circumference at 12 months. Waist circumference is taken by study nurse both at baseline and at the end of the study.
Time frame
From enrollment to the end of follow-up at 12 months4
Change from baseline in Body Roundness Index at 12 months
Change from baseline in Body Roundness Index at 12 months. Weight, height, waist and hip circumference are taken by study nurse both at baseline and at the end of the study.
Time frame
From enrollment to the end of follow-up at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kuopio University Hospital
Lead sponsor
Finnish Diabetes Association
Collaborator
University of Eastern Finland
Collaborator
Source ClinicalTrials.gov