Promote Health With Digital Tools Among Adults With Type 2 Diabetes/Prediabetes and/or Hypertension (DigiCare4You)

June 5, 2026 updated by: Yannis Manios, Harokopio University

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:

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1215

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Albania
    • Rruga E Dibrës
      • Tirana, Rruga E Dibrës, Albania, AL1005
        • Universiteti i Mjekësisë
  • Bulgaria
    • Varna
      • Varna, Varna, Bulgaria, 9002
        • Medical University of Varna
  • Greece
    • Attica
      • Athens, Attica, Greece, 17676
        • Harokopio University
  • Spain
    • Zaragoza
      • Zaragoza, Zaragoza, Spain, 50009
        • Universidad de Zaragoza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermediate hyperglycaemia DC4Y intervention group
Participants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care
Behavioral: mHealth self-management intervention
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).
Experimental: T2DM DC4Y intervention group
Participants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care
Behavioral: mHealth self-management intervention
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).
Active Comparator: Intermediate hyperglycaemia enhanced standard care group
Participants will receive enhanced standard care, including lifestyle recommendations
Behavioral: Standard care
Participants will receive standard care, including lifestyle recommendations.
Active Comparator: T2DM enhanced standard care group
Participants will receive enhanced standard care, including lifestyle recommendations
Behavioral: Standard care
Participants will receive standard care, including lifestyle recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 months (1st follow-up)
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.
Baseline and 24 months (2nd follow-up)
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.
Baseline and 12 months (1st follow-up)
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.
Baseline and 24 months (2nd follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Blood pressure [BP] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.
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)
Blood pressure [BP] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.
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)
Body weight [BW] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.
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)
Body weight [BW] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.
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)
Waist circumference [WC] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.
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)
Waist circumference [WC] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.
Baseline and 24 months (2nd follow-up)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change form Baseline in the BMI z-score of children at 12 months (1st follow-up)
Time Frame: Baseline and 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)
Baseline and 12 months (1st follow-up)
Change form Baseline in the BMI z-score of children at 24 months (2nd follow-up)
Time Frame: Baseline and 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)
Baseline and 24 months (2nd follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Collaborators

NYU Langone Health
Monash University
National and Kapodistrian University of Athens
University Ghent
Universidad de Zaragoza
La Trobe University
Baker Heart and Diabetes Institute
International Diabetes Federation
Centre for Research and Technology Hellas
University of Medicine, Tirana
PRIVANOVA SAS
METEDA SRL
Sant'Anna School of Advanced Studies
STICHTING INTERNATIONAL FOUNDATION FORINTEGRATED CARE
EUROPEAN UNION'S HORIZON 2020 RESEARCH AND INNOVATION PROGRAMME (Project Number: 945246)
Medical University of Varna

Investigators

  • Principal Investigator: Yannis Manios, Professor, Harokopio University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

December 20, 2025

Study Completion (Actual)

December 20, 2025

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 945246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

This has not been decided yet.

IPD Sharing Access Criteria

For the duration of the project, data will be stored in a Secure Cloud-Based Repository, managed by the Project Coordinator who will authorize access to project partners' staff; when partners or partners' staff leave the project, the access to the repository will be disabled. Third parties will be granted access to the data for research purposes, including validation of the results presented in scientific publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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