An interventional study of BitHabit digital application for behavioral lifestyle changes and Onnikka weight management digital application in Type 2 Diabetes, sponsored by Kuopio University Hospital. Recruiting at 1 site in Finland. Open to participants aged 35 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Health services research
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kuopio University Hospital is the lead sponsor of 135 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least one of the following:
age ≥ 55 years and at least two of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Digital interventions: BitHabit application and optionally Onnikka application
Other: BitHabit digital application for behavioral lifestyle changes · Other: Onnikka weight management digital application
Control group receives same enhancement in treatment plan, but no digital interventions
BitHabit digital application for behavioral lifestyle changes
Onnikka weight management digital application
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of follow-up at 12 months
Plan to share: No — Study permission does not allow sharing individual participant data.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.