Last reviewed · How we verify
NCT05648383: DigiCare4You
Promote Health With Digital Tools Among Adults With Type 2 Diabetes/Prediabetes and/or Hypertension
NA trial testing mHealth intervention in Type 2 Diabetes in 992 participants. Status unknown.
28 February 2025
Quick facts
| Lead sponsor | Harokopio University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 992 |
| Start date | 1 October 2022 |
| Primary completion | 28 February 2025 |
| Estimated completion | 28 February 2025 |
| Sites | 4 locations across Albania, Greece, Bulgaria, Spain |
Drugs / interventions tested
- mHealth intervention
- Standard care — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
- PreDiabetes — all drugs for PreDiabetes →
- Hypertension — all drugs for Hypertension →
Sponsor
Harokopio University
Who can join
18 and older, any sex, with Type 2 Diabetes or PreDiabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The DigiCare4You project will use digital tools for early screening, prevention and management of type 2 diabetes (T2D) and hypertension (HTN). An implementation study will be conducted, targeting more than 10,000 families in two Middle Income Countries (Albania and Bulgaria) and two High Income Countries (Greece and Spain), considering vulnerable groups. Schools will be used as an entry point to the community. Building on an existing procedure for children's periodic growth assessment, conducted by school nurses or in collaboration with local community health centers, parents/ caregivers will be screened via a non-invasive self-reported digital screening tool. Those identified at high risk for T2D will be referred for glycaemia testing (fasting plasma glucose and glycated hemoglobin, HbA1c), as well as blood pressure (BP) measurements, at local community health centers. Parents/ caregivers confirmed to have pre-diabetes or diabetes (and possibly high BP) will be invited to join a mHealth self-management intervention coordinated by the community healthcare workforce. The goal of this intervention is to involve high-risk adults in the treatment process and decision-making on personalized behavioral goals (e.g. diet, physical activity, smoking, alcohol, medication compliance) that meet their needs, and ultimately improve the health status of parents/caregivers, as well as the lifestyle of the entire family.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The revised-FINDRISC: A tool for type 2 diabetes risk screening across diverse populations incorporating sociodemographic indicators.
Vitoratou DI, Dimakopoulou K, Mavrogianni C, Karaglani E, et al · · 2026 · PMID 41794157 · DOI 10.1016/j.annepidem.2026.110064
Verify or expand the search:
- PubMed search for NCT05648383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Harokopio University trials
Trials by the same sponsor.
- NCT06997510 — Better4All Personalized Intervention · NA · not yet recruiting
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- NCT07120802 — Better4All Personalized Intervention Pilot Study · NA · recruiting
- NCT07190066 — MELIORA Data Collection Campaigns · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05648383 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harokopio University
- Last refreshed: 13 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05648383.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing