An interventional study of mHealth self-management intervention and Standard care in Type 2 Diabetes, PreDiabetes and Hypertension, sponsored by Harokopio University. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Harokopio University · Not applicable, Interventional, and Prevention
The goal of this hybrid type II effectiveness-implementation trial is to evaluate whether an intersectoral, digitally enabled, family-based intervention can prevent and manage type 2 diabetes mellitus (T2DM) and hypertension (HTN) in adults with intermediate hyperglycaemia or T2DM (with or without HTN), and improve growth outcomes in their children, across socioeconomically diverse communities in Albania, Bulgaria, Greece, and Spain.
The main questions it aims to answer are:
Researchers will compare the DigiCare4You intervention group to the enhanced standard care group to see if combining structured counselling, digital self-management tools, and school/community reinforcement improves cardiometabolic outcomes in adults and growth outcomes in children beyond standard national guideline-based care.
Participants will:
DigiCare4You is an EU-funded (Horizon 2020) hybrid type II effectiveness-implementation study conducted across four European countries: Albania, Bulgaria, Greece, and Spain. The study addresses a critical gap in chronic disease prevention by combining community-based screening with a digitally supported self-management intervention targeting adults at cardiometabolic risk and their families.
Background and rationale Type 2 diabetes mellitus (T2DM) and hypertension (HTN) are among the leading causes of preventable morbidity and mortality in Europe, disproportionately affecting socioeconomically vulnerable populations. Despite their high burden, early detection and sustained management remain inconsistently delivered, particularly among groups with limited engagement in preventive healthcare. DigiCare4You was designed to address this through an equity-focused, scalable model that integrates screening, prevention, and long-term self-management support within existing health and educational infrastructures.
Study design The study uses a cluster-randomised design, with municipalities allocated 1:1 to either the DigiCare4You intervention arm or the enhanced standard care arm. Randomisation at the municipality level was chosen to minimise contamination between participants and to enable delivery through existing local healthcare and school structures.
Screening approach A novel two-stage screening procedure was embedded within existing national child growth monitoring services, using routine interactions between families and health or educational services as entry points to reach parents and caregivers who might otherwise have limited contact with preventive care. Stage 1 involved a digital self-reported risk questionnaire based on the FINDRISC score. Adults scoring ≥10 were referred to Stage 2, which included glycaemic testing, blood pressure measurement, and anthropometric assessment at local healthcare centres. Adults confirmed with intermediate hyperglycaemia or T2DM, with or without HTN, were invited to join the intervention.
Intervention The 24-month intervention combined structured face-to-face counselling with continuous digital self-management support. Counselling was guided by the Transtheoretical Model and incorporated established behaviour change techniques including self-monitoring, goal setting, barrier problem solving, relapse prevention, and self-efficacy enhancement, delivered through a shared decision-making approach. Three intensive counselling sessions were provided in the first eight weeks, followed by ongoing support through four interoperable digital tools (MetaDieta, MyDiet, MetaClinic, DiaWatch) supporting nutrition counselling, clinical monitoring, and medication adherence. School- and community-based components reinforced healthy behaviours within the broader family environment.
The intervention was delivered by existing multidisciplinary healthcare teams (internists, general practitioners, diabetologists, nurses, and dietitians) within primary care settings, trained using standardised materials and operating procedures. All digital tools are classified as medical devices under EU MDR 2017/745 and were adapted to each national context prior to deployment.
Enhanced standard care Participants in the enhanced standard care arm received structured assessment and care consistent with national clinical guidelines, including regular monitoring visits with anthropometric, biochemical, and blood pressure measurements and feedback, at intervals appropriate to their metabolic status (every 12 months for intermediate hyperglycaemia; every 3-6 months for T2DM).
Evaluation The study simultaneously evaluates clinical effectiveness and implementation outcomes using a mixed-methods approach guided by three complementary frameworks: PRECEDE-PROCEED, RE-AIM, and CFIR. Primary effectiveness outcomes are changes in HbA1c (T2DM subgroup), fasting plasma glucose (intermediate hyperglycaemia subgroup), and BMI z-scores in children. Implementation outcomes include reach, adoption, fidelity, feasibility, and sustainability. Economic evaluation includes cost-effectiveness and budget impact analyses using Markov modelling over a lifetime horizon.
Study structure The project spans five and a half years across three phases: Phase 1 (context analysis, needs assessment, and participatory co-design with stakeholder advisory boards); Phase 2 (intervention implementation and evaluation); and Phase 3 (cost-effectiveness, scalability, and transferability assessment). Findings are intended to inform evidence-based recommendations for scaling the DigiCare4You model across European health systems.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 1,215 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Harokopio University is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
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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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care
Behavioral: mHealth self-management intervention
Participants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care
Behavioral: mHealth self-management intervention
Participants will receive enhanced standard care, including lifestyle recommendations
Behavioral: Standard care
Participants will receive enhanced standard care, including lifestyle recommendations
Behavioral: Standard care
A 24-month mHealth self-management intervention combining structured face-to-face counselling (n=5-7) with continuous digital support. Counselling follows the Transtheoretical Model, incorporating self-monitoring, goal setting, barrier problem solving, relapse prevention, and self-efficacy enhancement via shared decision-making. Three additional intensive sessions are delivered in weeks 2, 4, and 8, followed by ongoing support through four interoperable digital tools, supporting nutrition counselling, clinical monitoring, blood glucose and blood pressure self-monitoring, and medication adherence. Delivery is by multidisciplinary primary care teams using standardised operating procedures. Intervention intensity and visit schedules differ by metabolic subgroup (intermediate hyperglycaemia vs T2DM).
Participants will receive standard care, including lifestyle recommendations.
Change from Baseline in fasting plasma glucose [FPG] at 12 months (1st follow-up)
Fasting plasma glucose \[FPG\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.
Time frame: Baseline and 12 months (1st follow-up)
Change from Baseline in fasting plasma glucose [FPG] at 24 months (2nd follow-up)
Fasting plasma glucose \[FPG\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.
Time frame: Baseline and 24 months (2nd follow-up)
Change from Baseline in glycated hemoglobin [HbA1c] at 12 months (1st follow-up)
Glycated hemoglobin \[HbA1c\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.
Time frame: Baseline and 12 months (1st follow-up)
Change from Baseline in glycated hemoglobin [HbA1c] at 24 months (2nd follow-up)
Glycated hemoglobin \[HbA1c\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.
Time frame: Baseline and 24 months (2nd follow-up)
Change from Baseline in blood pressure [BP] (both systolic and diastolic) at 12 months (1st follow-up)
Blood pressure \[BP\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.
Time frame: Baseline and 12 months (1st follow-up)
Change from Baseline in blood pressure [BP] (both systolic and diastolic) at 24 months (2nd follow-up)
Blood pressure \[BP\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.
Time frame: Baseline and 24 months (2nd follow-up)
Change from Baseline in body weight [BW] at 12 months (1st follow-up)
Body weight \[BW\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.
Time frame: Baseline and 12 months (1st follow-up)
Change from Baseline in body weight [BW] at 24 months (2nd follow-up)
Body weight \[BW\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.
Time frame: Baseline and 24 months (2nd follow-up)
Change from Baseline in waist circumference [WC] at 12 months (1st follow-up)
Waist circumference \[WC\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.
Time frame: Baseline and 12 months (1st follow-up)
Change from Baseline in waist circumference [WC] at 24 months (2nd follow-up)
Waist circumference \[WC\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.
Time frame: Baseline and 24 months (2nd follow-up)
Change form Baseline in the BMI z-score of children at 12 months (1st follow-up)
Although children will not directly receive any intervention, their BMI z-score will be calculated at 12 months (1st follow-up) of the intervention for both groups. Change = (Month 12 score - Baseline score)
Time frame: Baseline and 12 months (1st follow-up)
Change form Baseline in the BMI z-score of children at 24 months (2nd follow-up)
Although children will not directly receive any intervention, their BMI z-score will be calculated at 24 months (2nd follow-up) of the intervention for both groups. Change = (Month 24 score - Baseline score)
Time frame: Baseline and 24 months (2nd follow-up)
Plan to share: Yes — De-identified individual participant data (IPD) collected throughout the DigiCare4You trial will be shared with consortium partners and may be made available to external researchers upon reasonable request. Shared data will include participant-level clinical, anthropometric, biochemical, and behavioural data collected at baseline, 12 months, and 24 months, as well as implementation-related data. Data will be shared in accordance with the study's Data Management Plan, applicable data protection legislation (EU GDPR), and the ethical approvals granted in each participating country. Requests for access will be reviewed by the study coordination team at Harokopio University of Athens. Further details on data availability, access criteria, and supporting documentation (including data dictionaries and analysis code) will be made available upon publication of the primary results.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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