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Outcomes-Based Health Program for Type 2 Diabetes

RecruitingNAAges 35 Years - 74 YearsAllKuopio University Hospital
NCT07322757 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 lif

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📋 Eligibility rules (as published)
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
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What it tests

  • BitHabit digital application for behavioral lifestyle changes
  • Onnikka weight management digital application
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Where

1 site
Wellbeing services county of North Savo, Nursing and Physician Services
Kuopio, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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