Type 2 DiabetesDigiCare4YouNCT05648383
Promote Health With Digital Tools Among Adults With Type 2 Diabetes/Prediabetes and/or Hypertension
A study testing mHealth self-management intervention in people with Type 2 Diabetes and PreDiabetes, run by Harokopio University at 4 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, PreDiabetes, Hypertension
- What is being tested?
- mHealth self-management intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,215 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Oct 2022to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People who have their permanent residence within the prefecture/region of the relevant facility participating in the clinical study.
- People having children at primary and/ or secondary education.
- People who are physically and mentally able to provide their informed consent to participate.
- People with a FINDRISC ≥10
- People with a fasting plasma glucose (FPG) ≥ 100 mg/dL and /or glycated hemoglobin (HbA1c) ≥ 5.7%
Who cannot join
- People suffering from a health condition where adherence to the intervention will be contraindicated or improbable.
- People unable to express a free and informed consent for medical and/or psychological conditions, mental incapacity.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: An Intersectoral Innovative Solution Involving DIGItal Tools, Empowering Families and Integrating Community CARE Services for the Prevention and Management of Type 2 Diabetes and Hypertension
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:
Read more
- Does the DigiCare4You intervention reduce HbA1c levels in adults with T2DM compared to enhanced standard care?
- Does the DigiCare4You intervention reduce fasting plasma glucose levels in adults with intermediate hyperglycaemia compared to enhanced standard care?
- Does the DigiCare4You intervention improve BMI z-scores in children linked to enrolled parents compared to enhanced standard care?
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:
- Complete a two-stage screening procedure, including a digital risk questionnaire and a clinical assessment, to confirm eligibility
- Attend structured assessment visits at regular intervals over 24 months, including anthropometric, biochemical, and blood pressure measurements
- Receive (intervention group only) three intensive face-to-face counselling sessions in the first eight weeks, followed by ongoing digital self-management support through interoperable mobile health tools
- Be encouraged to adopt healthier lifestyle behaviours as a family unit throughout the study period.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes, PreDiabetes, Hypertension, Obesity & Overweight
- Being tested
- mHealth self-management intervention, Standard care
- Keywords
- community, primary healthcare, families, m-health application, diabetes, hypertension, screening, lifestyle intervention, self-management, people-centred care, scaling-up
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Hypertension, Obesity, Overweight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth self-management interventionBehavioural
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).
Standard careBehavioural
Participants will receive standard care, including lifestyle recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Intermediate hyperglycaemia DC4Y intervention group | Experimental | Participants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care Receives: Behavioral: mHealth self-management intervention |
| T2DM DC4Y intervention group | Experimental | Participants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care Receives: Behavioral: mHealth self-management intervention |
| Intermediate hyperglycaemia enhanced standard care group | Active comparator | Participants will receive enhanced standard care, including lifestyle recommendations Receives: Behavioral: Standard care |
| T2DM enhanced standard care group | Active comparator | Participants will receive enhanced standard care, including lifestyle recommendations Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 24 months (2nd follow-up)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 24 months (2nd follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Oct 2022
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 1,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Varna, Centre for Research and Technology Hellas, University of Medicine, Tirana, La Trobe University, National and Kapodistrian University of Athens, NYU Langone Health, University Ghent, Universidad de Zaragoza, PRIVANOVA SAS, Monash University, METEDA SRL, Baker Heart and Diabetes Institute, Sant'Anna School of Advanced Studies, International Diabetes Federation, STICHTING INTERNATIONAL FOUNDATION FORINTEGRATED CARE, EUROPEAN UNION'S HORIZON 2020 RESEARCH AND INNOVATION PROGRAMME (Project Number: 945246)
- Responsible party
- Principal investigator, Yannis Manios, Harokopio University
- Investigators
- Yannis Manios, Professor, Principal investigator, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648383
- Sponsor's protocol ID
- 945246
- Acronym
- DigiCare4You
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Manios Y, Mavrogianni C, Lambrinou CP, Cardon G, Lindstrom J, Iotova V, Tankova T, Civeira F, Kivela J, Jancso Z, Shadid S, Tsochev K, Mateo-Gallego R, Rado S, Dafoulas G, Makrilakis K, Androutsos O; Feel4Diabetes-study group. Two-stage, school and community-based population screening successfully identifies individuals and families at high-risk for type 2 diabetes: the Feel4Diabetes-study. BMC Endocr Disord. 2020 Mar 12;20(Suppl 1):12. doi: 10.1186/s12902-019-0478-9.
PubMed 32164646Manios Y, Androutsos O, Lambrinou CP, Cardon G, Lindstrom J, Annemans L, Mateo-Gallego R, de Sabata MS, Iotova V, Kivela J, Martinez R, Moreno LA, Rurik I, Schwarz P, Tankova T, Liatis S, Makrilakis K. A school- and community-based intervention to promote healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: design and implementation of the Feel4Diabetes-study. Public Health Nutr. 2018 Dec;21(17):3281-3290. doi: 10.1017/S1368980018002136. Epub 2018 Sep 12.
PubMed 30207513Lindstrom J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003 Mar;26(3):725-31. doi: 10.2337/diacare.26.3.725.
PubMed 12610029Mavrogianni C, Lambrinou CP, Androutsos O, Lindstrom J, Kivela J, Cardon G, Huys N, Tsochev K, Iotova V, Chakarova N, Rurik I, Moreno LA, Liatis S, Makrilakis K, Manios Y; Feel4Diabetes-study group. Evaluation of the Finnish Diabetes Risk Score as a screening tool for undiagnosed type 2 diabetes and dysglycaemia among early middle-aged adults in a large-scale European cohort. The Feel4Diabetes-study. Diabetes Res Clin Pract. 2019 Apr;150:99-110. doi: 10.1016/j.diabres.2019.02.017. Epub 2019 Feb 20.
PubMed 30796939Oldenburg B, Taylor CB, O'Neil A, Cocker F, Cameron LD. Using new technologies to improve the prevention and management of chronic conditions in populations. Annu Rev Public Health. 2015 Mar 18;36:483-505. doi: 10.1146/annurev-publhealth-031914-122848. Epub 2015 Jan 12.
PubMed 25581147O'Neil A, Cocker F, Rarau P, Baptista S, Cassimatis M, Barr Taylor C, Lau AYS, Kanuri N, Oldenburg B. Using digital interventions to improve the cardiometabolic health of populations: a meta-review of reporting quality. J Am Med Inform Assoc. 2017 Jul 1;24(4):867-879. doi: 10.1093/jamia/ocw166.
PubMed 28339628Siopis G, Moschonis G, Eweka E, Jung J, Kwasnicka D, Asare BY, Kodithuwakku V, Willems R, Verhaeghe N, Annemans L, Vedanthan R, Oldenburg B, Manios Y; DigiCare4You Consortium. Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with hypertension: a systematic review and meta-analysis of randomised controlled trials. Lancet Digit Health. 2023 Mar;5(3):e144-e159. doi: 10.1016/S2589-7500(23)00002-X.
PubMed 36828607Moschonis G, Siopis G, Jung J, Eweka E, Willems R, Kwasnicka D, Asare BY, Kodithuwakku V, Verhaeghe N, Vedanthan R, Annemans L, Oldenburg B, Manios Y; DigiCare4You Consortium. Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials. Lancet Digit Health. 2023 Mar;5(3):e125-e143. doi: 10.1016/S2589-7500(22)00233-3.
PubMed 36828606Willems R, Annemans L, Siopis G, Moschonis G, Vedanthan R, Jung J, Kwasnicka D, Oldenburg B, d'Antonio C, Girolami S, Agapidaki E, Manios Y, Verhaeghe N; DigiCare 4You. Cost effectiveness review of text messaging, smartphone application, and website interventions targeting T2DM or hypertension. NPJ Digit Med. 2023 Aug 18;6(1):150. doi: 10.1038/s41746-023-00876-x.
PubMed 37596488Seghieri C, Ferre F, Tortu C, Bertarelli G, Mavrogianni C, Usheva N, Toti F, Moreno L, Agapidaki E, Manios Y. Addressing chronic diseases: a comparative study of policies towards type-2 diabetes and hypertension in selected European countries. Eur J Public Health. 2024 Aug 1;34(4):781-786. doi: 10.1093/eurpub/ckae070.
PubMed 38573190Tortu C, Seghieri C, Doracaj D, Usheva N, Gimenez-Legarre N, Manios Y. Understanding Health Care Workers' Attitudes and Preferences Toward Digital Patient Monitoring Platforms: Cross-Country Survey Study. JMIR Form Res. 2025 Sep 23;9:e67142. doi: 10.2196/67142.
PubMed 40986459Seghieri C, Feldens T, Tortu C, Usheva N, Toti F, Doracaj D, Gimenez-Legarre N, Karaglani E, Manios Y. Tailoring mobile health apps for lifestyle management: a discrete choice experiment. Mhealth. 2026 Jan 27;12:3. doi: 10.21037/mhealth-25-30. eCollection 2026.
PubMed 41675093Vitoratou DI, Dimakopoulou K, Mavrogianni C, Karaglani E, Argyropoulou M, Cardon G, Usheva N, Iotova V, Tankova T, Gimenez-Legarre N, Moreno LA, Toti F, Makrilakis K, Doracaj D, Imre R, Torzsa P, Lindstrom J, Panagiotakos D, Manios Y. The revised-FINDRISC: A tool for type 2 diabetes risk screening across diverse populations incorporating sociodemographic indicators. Ann Epidemiol. 2026 May;117:110064. doi: 10.1016/j.annepidem.2026.110064. Epub 2026 Mar 5.
PubMed 41794157
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intersectoral Innovative Solution Involving DIGItal Tools, Empowering Families and Integrating Community CARE Services for the Prevention and Management of Type 2 Diabetes and Hypertension
- ClinicalTrials.gov ID
- NCT05648383
- Acronym / sponsor ID
- DigiCare4You / 945246
- Conditions
- Type 2 Diabetes, PreDiabetes, Hypertension, Obesity & Overweight
- Keywords
- community, primary healthcare, families, m-health application, diabetes, hypertension, screening, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,215 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- Medical University of Varna, Centre for Research and Technology Hellas, University of Medicine, Tirana, La Trobe University, National and Kapodistrian University of Athens, NYU Langone Health, University Ghent, Universidad de Zaragoza, PRIVANOVA SAS, Monash University, METEDA SRL, Baker Heart and Diabetes Institute, Sant'Anna School of Advanced Studies, International Diabetes Federation, STICHTING INTERNATIONAL FOUNDATION FORINTEGRATED CARE, EUROPEAN UNION'S HORIZON 2020 RESEARCH AND INNOVATION PROGRAMME (Project Number: 945246)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 13 Dec 2022 (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.
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:
- Does the DigiCare4You intervention reduce HbA1c levels in adults with T2DM compared to enhanced standard care?
- Does the DigiCare4You intervention reduce fasting plasma glucose levels in adults with intermediate hyperglycaemia compared to enhanced standard care?
- Does the DigiCare4You intervention improve BMI z-scores in children linked to enrolled parents compared to enhanced standard care?
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:
- Complete a two-stage screening procedure, including a digital risk questionnaire and a clinical assessment, to confirm eligibility
- Attend structured assessment visits at regular intervals over 24 months, including anthropometric, biochemical, and blood pressure measurements
- Receive (intervention group only) three intensive face-to-face counselling sessions in the first eight weeks, followed by ongoing digital self-management support through interoperable mobile health tools
- Be encouraged to adopt healthier lifestyle behaviours as a family unit throughout the study period.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intermediate hyperglycaemia DC4Y intervention group | Experimental | Behavioral: mHealth self-management interventionParticipants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care |
| T2DM DC4Y intervention group | Experimental | Behavioral: mHealth self-management interventionParticipants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care |
| Intermediate hyperglycaemia enhanced standard care group | Active comparator | Behavioral: Standard careParticipants will receive enhanced standard care, including lifestyle recommendations |
| T2DM enhanced standard care group | Active comparator | Behavioral: Standard careParticipants will receive enhanced standard care, including lifestyle recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People who have their permanent residence within the prefecture/region of the relevant facility participating in the clinical study.
- People having children at primary and/ or secondary education.
- People who are physically and mentally able to provide their informed consent to participate.
- People with a FINDRISC ≥10
- People with a fasting plasma glucose (FPG) ≥ 100 mg/dL and /or glycated hemoglobin (HbA1c) ≥ 5.7%
Key exclusion criteria (2 listed)
- People suffering from a health condition where adherence to the intervention will be contraindicated or improbable.
- People unable to express a free and informed consent for medical and/or psychological conditions, mental incapacity.
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 |
|---|---|---|
| mHealth self-management interventionA 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). | Behavioural | Intermediate hyperglycaemia DC4Y intervention group, T2DM DC4Y intervention group |
| Standard careParticipants will receive standard care, including lifestyle recommendations. | Behavioural | Intermediate hyperglycaemia enhanced standard care group, T2DM enhanced standard care group |
Primary outcome
Change from Baseline in fasting plasma glucose [FPG] at 12 months (1st follow-up)
Time frame: Baseline and 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.
Change from Baseline in fasting plasma glucose [FPG] at 24 months (2nd follow-up)
Time frame: Baseline and 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.
Change from Baseline in glycated hemoglobin [HbA1c] at 12 months (1st follow-up)
Time frame: Baseline and 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.
Change from Baseline in glycated hemoglobin [HbA1c] at 24 months (2nd follow-up)
Time frame: Baseline and 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.
6 secondary outcomes
Change from Baseline in blood pressure [BP] (both systolic and diastolic) at 12 months (1st follow-up)
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)
Time frame: Baseline and 24 months (2nd follow-up)
Change from Baseline in body weight [BW] at 12 months (1st follow-up)
Time frame: Baseline and 12 months (1st follow-up)
Change from Baseline in body weight [BW] at 24 months (2nd follow-up)
Time frame: Baseline and 24 months (2nd follow-up)
Change from Baseline in waist circumference [WC] at 12 months (1st follow-up)
Time frame: Baseline and 12 months (1st follow-up)
Change from Baseline in waist circumference [WC] at 24 months (2nd follow-up)
Time frame: Baseline and 24 months (2nd follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 32164646Manios Y, Mavrogianni C, Lambrinou CP, Cardon G, Lindstrom J, Iotova V, Tankova T, Civeira F, Kivela J, Jancso Z, Shadid S, Tsochev K, Mateo-Gallego R, Rado S, Dafoulas G, Makrilakis K, Androutsos O; Feel4Diabetes-study group. Two-stage, school and community-based population screening successfully identifies individuals and families at high-risk for type 2 diabetes: the Feel4Diabetes-study. BMC Endocr Disord. 2020 Mar 12;20(Suppl 1):12. doi: 10.1186/s12902-019-0478-9.
- Background: PubMed 30207513Manios Y, Androutsos O, Lambrinou CP, Cardon G, Lindstrom J, Annemans L, Mateo-Gallego R, de Sabata MS, Iotova V, Kivela J, Martinez R, Moreno LA, Rurik I, Schwarz P, Tankova T, Liatis S, Makrilakis K. A school- and community-based intervention to promote healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: design and implementation of the Feel4Diabetes-study. Public Health Nutr. 2018 Dec;21(17):3281-3290. doi: 10.1017/S1368980018002136. Epub 2018 Sep 12.
- Background: PubMed 12610029Lindstrom J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003 Mar;26(3):725-31. doi: 10.2337/diacare.26.3.725.
- Background: PubMed 30796939Mavrogianni C, Lambrinou CP, Androutsos O, Lindstrom J, Kivela J, Cardon G, Huys N, Tsochev K, Iotova V, Chakarova N, Rurik I, Moreno LA, Liatis S, Makrilakis K, Manios Y; Feel4Diabetes-study group. Evaluation of the Finnish Diabetes Risk Score as a screening tool for undiagnosed type 2 diabetes and dysglycaemia among early middle-aged adults in a large-scale European cohort. The Feel4Diabetes-study. Diabetes Res Clin Pract. 2019 Apr;150:99-110. doi: 10.1016/j.diabres.2019.02.017. Epub 2019 Feb 20.
- Background: PubMed 25581147Oldenburg B, Taylor CB, O'Neil A, Cocker F, Cameron LD. Using new technologies to improve the prevention and management of chronic conditions in populations. Annu Rev Public Health. 2015 Mar 18;36:483-505. doi: 10.1146/annurev-publhealth-031914-122848. Epub 2015 Jan 12.
- Background: PubMed 28339628O'Neil A, Cocker F, Rarau P, Baptista S, Cassimatis M, Barr Taylor C, Lau AYS, Kanuri N, Oldenburg B. Using digital interventions to improve the cardiometabolic health of populations: a meta-review of reporting quality. J Am Med Inform Assoc. 2017 Jul 1;24(4):867-879. doi: 10.1093/jamia/ocw166.
- Results publication: PubMed 36828607Siopis G, Moschonis G, Eweka E, Jung J, Kwasnicka D, Asare BY, Kodithuwakku V, Willems R, Verhaeghe N, Annemans L, Vedanthan R, Oldenburg B, Manios Y; DigiCare4You Consortium. Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with hypertension: a systematic review and meta-analysis of randomised controlled trials. Lancet Digit Health. 2023 Mar;5(3):e144-e159. doi: 10.1016/S2589-7500(23)00002-X.
- Results publication: PubMed 36828606Moschonis G, Siopis G, Jung J, Eweka E, Willems R, Kwasnicka D, Asare BY, Kodithuwakku V, Verhaeghe N, Vedanthan R, Annemans L, Oldenburg B, Manios Y; DigiCare4You Consortium. Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials. Lancet Digit Health. 2023 Mar;5(3):e125-e143. doi: 10.1016/S2589-7500(22)00233-3.
- Results publication: PubMed 37596488Willems R, Annemans L, Siopis G, Moschonis G, Vedanthan R, Jung J, Kwasnicka D, Oldenburg B, d'Antonio C, Girolami S, Agapidaki E, Manios Y, Verhaeghe N; DigiCare 4You. Cost effectiveness review of text messaging, smartphone application, and website interventions targeting T2DM or hypertension. NPJ Digit Med. 2023 Aug 18;6(1):150. doi: 10.1038/s41746-023-00876-x.
- Results publication: PubMed 38573190Seghieri C, Ferre F, Tortu C, Bertarelli G, Mavrogianni C, Usheva N, Toti F, Moreno L, Agapidaki E, Manios Y. Addressing chronic diseases: a comparative study of policies towards type-2 diabetes and hypertension in selected European countries. Eur J Public Health. 2024 Aug 1;34(4):781-786. doi: 10.1093/eurpub/ckae070.
- Results publication: PubMed 40986459Tortu C, Seghieri C, Doracaj D, Usheva N, Gimenez-Legarre N, Manios Y. Understanding Health Care Workers' Attitudes and Preferences Toward Digital Patient Monitoring Platforms: Cross-Country Survey Study. JMIR Form Res. 2025 Sep 23;9:e67142. doi: 10.2196/67142.
- Results publication: PubMed 41675093Seghieri C, Feldens T, Tortu C, Usheva N, Toti F, Doracaj D, Gimenez-Legarre N, Karaglani E, Manios Y. Tailoring mobile health apps for lifestyle management: a discrete choice experiment. Mhealth. 2026 Jan 27;12:3. doi: 10.21037/mhealth-25-30. eCollection 2026.
- DigiCare4You link websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Yannis Manios, Professor principal investigator
Harokopio University
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth self-management intervention in people with Type 2 Diabetes and PreDiabetes, run by Harokopio University at 4 sites in 4 countries.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Albania, Bulgaria, Greece, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in fasting plasma glucose [FPG] at 12 months (1st follow-up) (time frame: Baseline and 12 months (1st follow-up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648383, which also lists 13 linked publications.
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 9 Jun 2026.