Outcomes-focused health program for people with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The program provides adults with high-risk type 2 diabetes access to the BitHabit "Small Actions" app to support healthy habits and offers the Onnikka weight-management app for participants with BMI > 30. The digital interventions are delivered alongside optimized routine medical care within the North Savo healthcare system. Study outcomes include clinical measures, patient-reported outcome measures (PROMs, PAID), and healthcare utilization related to diabetes complications. Enrollment targets patients with established cardiovascular, renal, retinal disease, prior stroke or atrial fibrillation, or older adults with multiple cardiometabolic risk factors.

Why it matters

Who can join: the full rules

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

Where it's running

• Wellbeing services county of North Savo, Nursing and Physician Services
  Kuopio, Northern Savonia, Finland Recruiting

Study contacts

• Principal investigator: Sonja Soininen, MD, PhD — Wellbeing Services County of North Savo, Kuopio, Finland
• Study coordinator: Elina Pimiä, MD
• Email: elina.pimia@diabetes.fi
• Phone: +358503222755

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.