Outcomes-Based Health Program for Type 2 Diabetes

NCT ID: NCT07322757

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Digital intervention arm

Digital interventions: BitHabit application and optionally Onnikka application

Group Type: EXPERIMENTAL

BitHabit digital application for behavioral lifestyle changes

Intervention Type: OTHER

BitHabit digital application for behavioral lifestyle changes

Onnikka weight management digital application

Intervention Type: OTHER

Onnikka weight management digital application

Control group

Control group receives same enhancement in treatment plan, but no digital interventions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BitHabit digital application for behavioral lifestyle changes

BitHabit digital application for behavioral lifestyle changes

Intervention Type: OTHER

Onnikka weight management digital application

Onnikka weight management digital application

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Type 2 diabetes diagnosed
• At least one of the following:

1. diagnosed coronary artery disease,

2. diagnosed periferal artery disease,

3. diagnosed heart failure,

4. diagnosed diabetic renal disease (GFR <60 OR uACR ≥ 3 for at least three months),

5. diagnosed diabetic retinopathy,

6. previous stroke,

7. diagnosed atrial fibrillation or atrial flutter,

8. age ≥ 55 years and at least two of the following conditions:

1. smoker

2. uses antihypertensive medication or systolic blood pressure >140 mmHg or diastolic blood pressure > 80 mmHg,

3. uses lipid lowering medication or LDL-cholesterol > 2.6 or

4. BMI > 25

Exclusion Criteria

• eGFR < 30
• uACR > 200
• BMI > 50
• heart ejection fraction EF < 30
• active cancer or less than five years from cancer treatment at enrollment
• blindness in both eyes
• severe psychotic depression
• inability to utilize digital applications

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Finnish Diabetes Association

OTHER

Sponsor Role: collaborator

University of Eastern Finland

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sonja Soininen

Physician in Chief, Teaching clinic Osmo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonja Soininen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wellbeing Services County of North Savo, Kuopio, Finland

Locations

Wellbeing services county of North Savo, Nursing and Physician Services

Kuopio, Northern Savonia, Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Elina Pimiä, MD

Role: CONTACT

elina.pimia@diabetes.fi

+358503222755

Sonja Soininen, MD, PhD

Role: CONTACT

sonja.soininen@pshyvinvointialue.fi

+358444611199

Facility Contacts

Sonja Soininen, MD, PhD

Role: primary

sonja.soininen@pshyvinvointialue.fi

+358444611199

Other Identifiers

5103906

Identifier Type: -

Identifier Source: org_study_id