Type 2 DiabetesPREMAPNCT07820800
NMR Metabolomics-Based Risk Assessment and Stratified Digital Health Interventions in Middle-Aged Adults (PREMAP)
A study testing Digital health interventions in people with Type 2 Diabetes and Coronary Heart Disease, run by University of Eastern Finland at 1 site in Finland.
Trial summary
PREMAP invites residents of the Eloisa region (South Savo, Finland) turning 45, 50, or 55 years of age in 2026 to undergo a blood-based NMR metabolomics risk assessment for five interlinked cardio-renal-metabolic conditions (type 2 diabetes, coronary heart disease/myocardial infarction, stroke/cardiovascular disease… Read more about this study
- Who is it for?
- Ages 45 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Coronary Heart Disease, Myocardial Infarction
- What is being tested?
- Digital health interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2026to Mar 2028
- Phase
- Interventional
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 45 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Permanent resident of the Eloisa Wellbeing Services County (South Savo, Finland), or has selected Eloisa primary health care as their primary public care provider
- Turning 45, 50, or 55 years of age during calendar year 2026
- NMR metabolomics-based risk assessment result classified as low, moderate, or high multi-disease risk
- Able to provide written informed consent digitally
- Able to use a smartphone, tablet, or computer for digital application access
- Resident of Finland with a Finnish personal identity code (required for health register linkage)
Who cannot join
- Currently pregnant or breastfeeding
- Incarcerated or under forensic psychiatric care
- Significantly impaired capacity for self-determination
- Insufficient proficiency in Finnish to provide informed consent and complete study procedures
- No Finnish personal identity code
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 South Savo (Eloisa) (provide social and healthcare services and emergency services in the Enonkoski, Hirvensalmi, Juva, Kangasniemi, Mikkeli, Mäntyharju, Pieksämäki, Puumala, Rantasalmi, Savonlinna ja Sulkava)
Savonlinna
Anna-Sofia Simula, +35840 1294676, anna-sofia.simula@etelasavonha.fi
About this study
Official title: Effectiveness and Cost-Effectiveness of NMR Metabolomics-Based Risk Assessment and Stratified Preventive Digital and Guideline-Directed Interventions in a Middle-Aged Population: A Population Cohort Study With an Embedded Pragmatic Randomised Trial and Health Economic Evaluation
PREMAP invites residents of the Eloisa region (South Savo, Finland) turning 45, 50, or 55 years of age in 2026 to undergo a blood-based NMR metabolomics risk assessment for five interlinked cardio-renal-metabolic conditions (type 2 diabetes, coronary heart disease/myocardial infarction, stroke/cardiovascular disease, chronic kidney disease, and fatty liver disease), alongside a mental wellbeing assessment (WHO-5 Well-Being Index). Based on this risk profile, participants are classified as low, moderate, or high multi-disease risk. Participants at moderate or high risk are individually randomized in a 1:1:1 ratio to one of three digital health interventions for up to 12 months: a habit-based lifestyle application (BitHabit), a structured digital lifestyle coaching programme (Onnikka), or a guideline-based digital self-care pathway (Oma Eloisa, comparator). Participants at high risk additionally receive a physician consultation and optimization of guideline-directed medical therapy. All participants, including the non-randomized low-risk group, are followed prospectively at baseline, 6 months, and 12 months. The study evaluates whether early risk identification and risk-stratified digital interventions reduce future disease risk and improve wellbeing and estimates the cost-effectiveness of the overall approach for the Finnish healthcare system.
Read the detailed description
The study addresses an evidence gap: no published pragmatic, randomized trial has directly compared digital lifestyle intervention platforms in a population prospectively risk-stratified through NMR metabolomics in a real-world public-sector setting. PREMAP combines a prospective, population-based cohort (all enrolled participants, followed regardless of risk group) with an embedded pragmatic, open-label, three-arm randomized controlled trial restricted to participants classified as moderate or high multi-disease risk. The non-randomized low-risk group receives its risk result and general health information and is followed as a naturalistic reference group; withholding a risk result or randomizing this group to an active digital intervention was judged neither scientifically nor ethically justified.
At the population cohort level, the study evaluates change from baseline to 6 months in the five NMR-derived disease-specific risk predictions and in the WHO-5 wellbeing score across all enrolled participants. Within the embedded randomised substudy, the three digital health arms are compared head-to-head on the same two outcome domains at 6 months, adjusting for guideline-directed medical therapy status and relevant covariates. Secondary objectives include patient-reported outcomes (health-related quality of life, work productivity, health activation, life satisfaction), clinical and health-register-based outcomes (incident diagnoses, new prescriptions, hospitalization, sickness absence) over at least 12 months, and a health economic evaluation using patient-level Monte Carlo microsimulation to estimate cost per quality-adjusted life year (QALY) gained, from both healthcare payer and societal perspectives.
- Conditions
- Type 2 Diabetes, Coronary Heart Disease, Myocardial Infarction, Cerebrovascular Disease, Stroke, Chronic Kidney Disease
- Being tested
- Digital health interventions
- Keywords
- cardio-renal-metabolic risk, preventive medicine, metabolomics, digital health intervention, risk stratification, primary prevention, wellbeing, health economics
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Disease, Myocardial Infarction, Cerebrovascular Disorders, Stroke, Renal Insufficiency, Chronic, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital health interventionsBehavioural
Also called BitHabit digital lifestyle app, Onnikka digital lifestyle coachingy, Oma Eloisa digital self-care pathway
Arm 1: BitHabit digital lifestyle app (12 months); Arm 2: Onnikka digital lifestyle coaching (12 months); Arm 3: Oma Eloisa digital self-care pathway (comparator). High-risk participants additionally receive physician consultation + Guideline-Directed Medical Treatment (GDMT) optimisation in the high-risk arm.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BitHabit | Experimental | Digital, self-directed lifestyle behavior-change smartphone application based on habit-formation and behavioral-economics principles. Provides personalized, small, achievable habit suggestions targeting physical activity, nutrition, sleep, stress management and recovery. Active engagement up to 6 months from randomization; app access continues to 12 months. Receives: Behavioral: Digital health interventions |
| Arm 2: Onnikka | Experimental | Digital lifestyle coaching programme grounded in cognitive behavioral therapy and acceptance and commitment therapy, focused on sustainable weight management and metabolic risk reduction through structured programme modules, automated check-ins and optional peer support. Active engagement up to 12 months from randomization. Receives: Behavioral: Digital health interventions |
| Arm 3: Oma Eloisa | Active comparator | Structured digital self-care pathway based on national clinical guidelines, providing lifestyle information, guidance and self-monitoring tools without personalized coaching or professional support. Represents the current standard of digital support available in the Eloisa region and is used as the comparator arm; low-risk participants also use this pathway on a non-randomized basis. Continuous access throughout the follow-up period (up to 12 months). Receives: Behavioral: Digital health interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
NMR-derived disease-specific 10-year risk predictions
Change from baseline in NMR-derived disease-specific 10-year risk predictions (type 2 diabetes, coronary heart disease/myocardial infarction, stroke/cardiovascular disease, chronic kidney disease, fatty liver disease)
Measured: Baseline to 6 months
The World Health Organization-Five Well-Being Index (WHO-5)
Change from baseline in WHO-5 Well-Being Index. A percentage score ranging from zero to 100; zero represents worst possible mental well-being; a score of 100 represents best possible mental well-being.
Measured: Baseline to 6 months (primary); baseline to 12 months (secondary time point)
Secondary outcomes (17)
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
EQ-5D-5L index score (obtained applying the Nordic value sets (Denmark, Norway, Sweden)) ranging from -0.285 to one; -0.285 indicates condition worse than death and one full health.
Measured: baseline and at 6 and 12 months
Incident diagnoses of the five target conditions
Unit of measurement is incidence of Chronic Kidney Disease, Type 2 Diabetes, Myocardial Infarction, Stroke, and Fatty Liver Disease (MASLD). Measurement tool from health registers (Eloisa´s EHR system, AvoHilmo, Hilmo).
Measured: Over at least 12 months
Cost-effectiveness
Incremental cost per quality-adjusted life year (QALY) gained across the three intervention arms and at the population level, estimated via microsimulation, from healthcare payer and societal perspectives
Measured: Over at least 12 months
Work Productivity and Activity Impairment - General Health (WPAI-GH)
Four WPAI-GH subscales: absenteeism, presenteeism, overall work impairment, and activity impairment. All subscales range from zero to 100% with zero indicating no impairment and 100% indicating full impairment.
Measured: Baseline to 6 and 12 months
Consumer Health Activation Index (CHAI)
The ten-item CHAI score ranges from 0 to 100, with higher scores indicating greater health activation. A score of 0 indicates the lowest level of health activation, while a score of 100 indicates the highest level of health activation.
Measured: Baseline to 6 and 12 months
Vitality (TARMO)
One question with five levels. Range 1-5, 0ne indicates full vitality and five no vitality.
Measured: Baseline to 6 and 12 months
Self-rated health
One question with five levels. Range 1-5, one indicate good health and 5 indicates poor health.
Measured: Baseline to 6 and 12 months
Net Promoter Score (NPS)
NPS score is measured with a single-question survey and reported with a number ranging from -100 to +100, where a higher score is desirable.
Measured: Baseline to 6 and 12 months
New relevant prescriptions
Proportion of patients with new prescriptions for antidiabetic, antihypertensive, lipid-lowering, and renal protective drugs (Eloisa's EHR system, Kela medicine reimbursement register).
Measured: Over at least 12 months
Work absenteeism
Number of sickness allowance days (Eloisa's EHR system, Kela register).
Measured: Over at least 12 months
Work disability
Number of disability pension days (ETK register).
Measured: Over at least 12 months
Hospitalization
Number of all-cause and cause-specific hospitalization days (Eloisa's EHR system, Hilmo, THL).
Measured: Over at least 12 months
Primary care visit rates
Primary care visit rates (Eloisa's EHR system, AvoHilmo, THL)
Measured: Over at least 12 months
Completion of the digital pathway
Indicator (0/1) of digital pathway successfully initiated for the participant. Zero indicates not initiated and one successful initiation.
Measured: Baseline
Completion of blood sampling
Indicator (0/1) of NMR blood sampling completed as planned for the participant. Zero indicates not completed and one successful completion.
Measured: Baseline and 6 months
Completion of risk-report delivery
Indicator (0/1) of risk report successfully returned to the participant. Zero indicates no return and one successful return.
Measured: Baseline and 6 months
Correct intervention allocation relative to risk stratum
Indicator (0/1) of correct intervention allocation relative to risk stratum. Zero indicates false and one correct intervention allocation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Sitra, the Finnish Innovation Fund, Wellbeing Services County of South Savo (Eloisa), Nightingale Health Plc
- Responsible party
- Principal investigator, Janne Martikainen, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820800
- Sponsor's protocol ID
- 189/2026
- Acronym
- PREMAP
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to Share Individual Participant Data (IPD): Case-by-case. The full trial protocol (current version) will be deposited on the trial registry and in the Finnish national research data storage service (IDA) at the time of registration. Requests for data sharing beyond the deposited protocol will be considered by the Trial Steering Committee on a case-by-case basis, subject to GDPR compliance and Findata regulations. Results and publications: all primary and secondary results are intended for peer-reviewed open-access publication (CC BY 4.0), following ICMJE authorship criteria.