NCT07322757 Outcomes-Based Health Program for Type 2 Diabetes
| NCT ID | NCT07322757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kuopio University Hospital |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-04-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Sonja Soininen, MD, PhD
PRINCIPAL INVESTIGATOR
Wellbeing Services County of North Savo, Kuopio, Finland
Frequently Asked Questions
Who can join the NCT07322757 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 74 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07322757 currently recruiting?
Yes, NCT07322757 is actively recruiting participants. Contact the research team at elina.pimia@diabetes.fi for enrollment information.
Where is the NCT07322757 trial being conducted?
This trial is being conducted at Kuopio, Finland.
Who is sponsoring the NCT07322757 clinical trial?
NCT07322757 is sponsored by Kuopio University Hospital. The principal investigator is Sonja Soininen, MD, PhD at Wellbeing Services County of North Savo, Kuopio, Finland. The trial plans to enroll 200 participants.
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