CompletedNot Applicable

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

Albania, Bulgaria, Greece1,215 participantsStarted 2022-10-01

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial has already been completed — can you tell me if the results showed any meaningful improvements in blood sugar levels like fasting plasma glucose or HbA1c, and whether those changes would be considered clinically significant for someone in my situation?
2The study tracked participants over 24 months using digital tools to help manage Type 2 diabetes, prediabetes, or hypertension — do you think a digital health approach like this could realistically fit into my daily routine, or would a more hands-on program be a better match for me?
3Since this trial is finished and has no traditional treatment phase listed, does that mean it was comparing digital tools against standard care, and if so, how does what they found compare to what you'd already recommend for managing my blood sugar?
4The study enrolled people with a range of overlapping conditions including prediabetes, Type 2 diabetes, hypertension, and obesity — given my specific diagnosis, do you think the findings from a mixed group like this would actually apply to my case?
5Are there published results or data from this trial you could share with me, so we can discuss whether the kind of digital health support it tested is something worth exploring as part of my overall treatment plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in fasting plasma glucose [FPG] at 12 months (1st follow-up)

Timeframe: Baseline and 12 months (1st follow-up)

Change from Baseline in fasting plasma glucose [FPG] at 24 months (2nd follow-up)

Timeframe: Baseline and 24 months (2nd follow-up)

Change from Baseline in glycated hemoglobin [HbA1c] at 12 months (1st follow-up)

Timeframe: Baseline and 12 months (1st follow-up)

Change from Baseline in glycated hemoglobin [HbA1c] at 24 months (2nd follow-up)

Timeframe: Baseline and 24 months (2nd follow-up)

Trial details

NCT IDNCT05648383

SponsorHarokopio University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-20

View on ClinicalTrials.gov More Type 2 Diabetes trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from Baseline in fasting plasma glucose [FPG] at 12 months (1st follow-up)

Timeframe: Baseline and 12 months (1st follow-up)

Change from Baseline in fasting plasma glucose [FPG] at 24 months (2nd follow-up)

Timeframe: Baseline and 24 months (2nd follow-up)

Change from Baseline in glycated hemoglobin [HbA1c] at 12 months (1st follow-up)

Timeframe: Baseline and 12 months (1st follow-up)

Change from Baseline in glycated hemoglobin [HbA1c] at 24 months (2nd follow-up)

Timeframe: Baseline and 24 months (2nd follow-up)