Outcomes-focused health program for people with 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

This study tests whether giving adults with high-risk type 2 diabetes access to a digital lifestyle program (BitHabit, and Onnikka for those with BMI over 30) together with optimized medical care can improve treatment and reduce complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 35 Years to 74 Years
• Sex: All
• Sponsor: Kuopio University Hospital (Academic / other)
• Locations: 1 site (Kuopio, Northern Savonia)
• Trial ID: NCT07322757 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with diagnosed type 2 diabetes who are at high risk for complications—such as those with cardiovascular disease, diabetic kidney or eye disease, prior stroke or atrial fibrillation, or age ≥55 with multiple risk factors—and who can use digital apps are ideal candidates.

Not a fit: Patients with very advanced or limiting conditions (eGFR <30, uACR >200, BMI >50, EF <30), recent/active cancer, bilateral blindness, severe psychotic depression, or inability to use digital applications are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the program could help people improve blood sugar control, lose weight, enhance quality of life, and reduce future diabetes complications.

How similar studies have performed: Previous trials of digital lifestyle and weight-management programs have shown modest improvements in weight, glycemic control, and patient-reported outcomes, though long-term effects on hard complications are still uncertain.

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

Where this trial is running

Kuopio, Northern Savonia

• 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

Conditions Type 2 Diabetes; Type 2 diabetes; High-risk type 2 diabetes patients; Digital lifestyle intervention; PROM; PAID