Type 2 DiabetesNCT07322757
Outcomes-Based Health Program for Type 2 Diabetes
A study testing BitHabit digital application for behavioral lifestyle changes and Onnikka weight management digital application in people with Type 2 Diabetes, run by Kuopio University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- BitHabit digital application for behavioral lifestyle changes and Onnikka weight management digital application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 10 Apr 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Wellbeing services county of North Savo, Nursing and Physician Services
Kuopio, Northern Savonia
Sonja Soininen, MD, PhD, +358444611199, sonja.soininen@pshyvinvointialue.fi
Sonja Soininen, MD, PhD
About this study
Official title: 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.
Read more
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.
- Conditions
- Type 2 Diabetes
- Being tested
- BitHabit digital application for behavioral lifestyle changes, Onnikka weight management digital application
- Keywords
- Type 2 diabetes, High-risk type 2 diabetes patients, Digital lifestyle intervention, PROM, PAID
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BitHabit digital application for behavioral lifestyle changesOther
BitHabit digital application for behavioral lifestyle changes
Onnikka weight management digital applicationOther
Onnikka weight management digital application
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention arm | Experimental | Digital interventions: BitHabit application and optionally Onnikka application Receives: Other: BitHabit digital application for behavioral lifestyle changes; Other: Onnikka weight management digital application |
| Control group | No intervention | Control group receives same enhancement in treatment plan, but no digital interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weight at 12 months
Change from baseline in weight at 12 months. Weight measurement is taken by study nurse both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in BMI at 12 months
Change from baseline in BMI at 12 months. Weight and height measurement are taken by study nurse both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in waist circumference at 12 months
Change from baseline in waist circumference at 12 months. Waist circumference is taken by study nurse both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in Body Roundness Index at 12 months
Change from baseline in Body Roundness Index at 12 months. Weight, height, waist and hip circumference are taken by study nurse both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in HbA1c at 12 months
Change from baseline in HbA1c at 12 months. HbA1c is a laboratory measurement describing glucose levels, taken both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in serum lipid levels at 12 months
Change from baseline in serum lipid levels at 12 months. LDL, HDL and triglycerides are laboratory measurements taken both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in smoking status at 12 months
Change from baseline in smoking status at 12 months. Smoking status is surveyed both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in physical activity at 12 months
Change from baseline in physical activity at 12 months. Physical activity is surveyed both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in dietary habits at 12 months
Change from baseline in dietary habits at 12 months. Dietary habits are surveyed both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in blood pressure at 12 months
Change from baseline in blood pressure at 12 months. Blood pressure measurement is taken by study nurse via Riva Rocci method both at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Self-reported changes from baseline in qualty of life measured by EQ-5D-5L at 12 months
EQ-5D-5L is a standard health questionnaire assessing quality of life across five dimensios: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. EQ-5D-5L questionnaire is filled electronically at baseline and at the end of the study.
Measured: From enrollment to the end of follow-up at 12 months
Change from baseline in Problem Areas in Diabetes (PAID) scale at 12 months
PAID scale identifies emotional distress in diabetes, covering issues like worrying complications, goal setting, food, treatment, and social support, common problems including fear, anger, feeling overwhelmed and guilt.
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start10 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Diabetes Association, University of Eastern Finland
- Responsible party
- Principal investigator, Sonja Soininen, Kuopio University Hospital
- Investigators
- Sonja Soininen, MD, PhD, Principal investigator, Wellbeing Services County of North Savo, Kuopio, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322757
- Sponsor's protocol ID
- 5103906
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study permission does not allow sharing individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes-Based Health Program for Improving Care and Outcomes in Patients With Type 2 Diabetes: A Real-World Implementation Study in Primary Care
- ClinicalTrials.gov ID
- NCT07322757
- Acronym / sponsor ID
- 5103906
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, High-risk type 2 diabetes patients, Digital lifestyle intervention, PROM, PAID
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Finnish Diabetes Association, University of Eastern Finland
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital intervention arm | Experimental | Other: BitHabit digital application for behavioral lifestyle changes, Other: Onnikka weight management digital applicationDigital interventions: BitHabit application and optionally Onnikka application |
| Control group | No intervention | –Control group receives same enhancement in treatment plan, but no digital interventions |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Type 2 diabetes diagnosed
- At least one of the following:
Key exclusion criteria (8 listed)
- eGFR < 30
- uACR > 200
- BMI > 50
- heart ejection fraction EF < 30
- active cancer or less than five years from cancer treatment at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BitHabit digital application for behavioral lifestyle changesBitHabit digital application for behavioral lifestyle changes | Other | Digital intervention arm |
| Onnikka weight management digital applicationOnnikka weight management digital application | Other | Digital intervention arm |
Primary outcome
Change from baseline in weight at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in weight at 12 months. Weight measurement is taken by study nurse both at baseline and at the end of the study.
Change from baseline in BMI at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in BMI at 12 months. Weight and height measurement are taken by study nurse both at baseline and at the end of the study.
Change from baseline in waist circumference at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in waist circumference at 12 months. Waist circumference is taken by study nurse both at baseline and at the end of the study.
Change from baseline in Body Roundness Index at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in Body Roundness Index at 12 months. Weight, height, waist and hip circumference are taken by study nurse both at baseline and at the end of the study.
Change from baseline in HbA1c at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in HbA1c at 12 months. HbA1c is a laboratory measurement describing glucose levels, taken both at baseline and at the end of the study.
Change from baseline in serum lipid levels at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in serum lipid levels at 12 months. LDL, HDL and triglycerides are laboratory measurements taken both at baseline and at the end of the study.
Change from baseline in smoking status at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in smoking status at 12 months. Smoking status is surveyed both at baseline and at the end of the study.
Change from baseline in physical activity at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in physical activity at 12 months. Physical activity is surveyed both at baseline and at the end of the study.
Change from baseline in dietary habits at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in dietary habits at 12 months. Dietary habits are surveyed both at baseline and at the end of the study.
Change from baseline in blood pressure at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
Change from baseline in blood pressure at 12 months. Blood pressure measurement is taken by study nurse via Riva Rocci method both at baseline and at the end of the study.
Self-reported changes from baseline in qualty of life measured by EQ-5D-5L at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
EQ-5D-5L is a standard health questionnaire assessing quality of life across five dimensios: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. EQ-5D-5L questionnaire is filled electronically at baseline and at the end of the study.
Change from baseline in Problem Areas in Diabetes (PAID) scale at 12 months
Time frame: From enrollment to the end of follow-up at 12 months
PAID scale identifies emotional distress in diabetes, covering issues like worrying complications, goal setting, food, treatment, and social support, common problems including fear, anger, feeling overwhelmed and guilt.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. Study permission does not allow sharing individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonja Soininen, MD, PhD principal investigator
Wellbeing Services County of North Savo, Kuopio, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BitHabit digital application for behavioral lifestyle changes and Onnikka weight management digital application in people with Type 2 Diabetes, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elina Pimiä, MD (+358503222755, elina.pimia@diabetes.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weight at 12 months (time frame: From enrollment to the end of follow-up at 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.