NCT07322757

Outcomes-Based Health Program for Type 2 Diabetes

Outcomes-Based Health Program for Improving Care and Outcomes in Patients With Type 2 Diabetes: A Real-World Implementation Study in Primary Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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

• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	BitHabit digital application for behavioral lifestyle changes	BitHabit digital application for behavioral lifestyle changes
OTHER	Onnikka weight management digital application	Onnikka weight management digital application

Timeline

• Start date: 2025-04-10
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Finland