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Digital lifestyle apps alongside usual care for adults with type 2 diabetes

Tests lifestyle and weight management phone apps in adults with type 2 diabetes.

Plain-language title generated from the registry record
Registry title: Outcomes-Based Health Program for Type 2 Diabetes

Key facts

Where
Kuopio, FinlandSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 35 and 74 years old?

Source: NCT07322757, who can take part

Where in Finland

  • Wellbeing services county of North Savo, Nursing and Physician ServicesKuopio, FinlandTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Kuopio University Hospital
Trial code
NCT07322757
Record updated
7 January 2026
Original description
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.Read full original descriptionShow less

Outcomes-Based Health Program for Improving Care and Outcomes in Patients With Type 2 Diabetes: A Real-World Implementation Study in Primary Care

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.

Inclusion: Type 2 diabetes diagnosed; At least one of the following:; diagnosed coronary artery disease,; diagnosed periferal artery disease,; diagnosed heart failure,; diagnosed diabetic renal disease (GFR <60 OR uACR ≥ 3 for at least three months),; diagnosed diabetic retinopathy,; previous stroke,; diagnosed atrial fibrillation or atrial flutter,; age ≥ 55 years and at least two of the following conditions:; smoker; uses antihypertensive medication or systolic blood pressure >140 mmHg or diastolic blood pressure > 80 mmHg,; uses lipid lowering medication or LDL-cholesterol > 2.6 or; BMI > 25.

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

ClinicalTrials.gov NCT07322757