Actively Recruiting
Outcomes-Based Health Program for Type 2 Diabetes
Led by Kuopio University Hospital · Updated on 2026-01-07
200
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
K
Kuopio University Hospital
Lead Sponsor
F
Finnish Diabetes Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Outcomes-Based Health Program for Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes
- Have at least one of the following conditions: coronary artery disease, peripheral artery disease, heart failure, diabetic kidney disease (GFR <60 or uACR ≥3 for at least three months), diabetic retinopathy, previous stroke, atrial fibrillation or atrial flutter
- Or be 55 years or older with at least two of these: smoker; uses blood pressure medicine or has blood pressure over 140/80 mmHg; uses cholesterol-lowering medicine or has LDL cholesterol over 2.6; BMI over 25
- Age between 35 and 74 years
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) below 30
- Urine albumin-to-creatinine ratio (uACR) over 200
- Body mass index (BMI) over 50
- Heart ejection fraction less than 30
- Active cancer or cancer treatment within the last five years
- Blindness in both eyes
- Severe psychotic depression
- Inability to use digital applications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wellbeing services county of North Savo, Nursing and Physician Services
Kuopio, Northern Savonia, Finland
Actively Recruiting
Research Team
E
Elina Pimiä, MD
CONTACT
S
Sonja Soininen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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