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

NCT05648383 | Completed

• 1 other identifier: 945246
• Study Type: interventional
• Target: 1,215
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Type 2 Diabetes; PreDiabetes; Hypertension; Obesity & Overweight

Keywords

community; primary healthcare; families; m-health application; diabetes; hypertension; screening; lifestyle intervention; self-management; people-centred care; scaling-up

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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)

  Baseline and 12 months (1st follow-up)

• Change from Baseline in blood pressure [BP] (both systolic and diastolic) at 24 months (2nd follow-up)

  Baseline and 24 months (2nd follow-up)

• Change from Baseline in body weight [BW] at 12 months (1st follow-up)

  Baseline and 12 months (1st follow-up)

• Change from Baseline in body weight [BW] at 24 months (2nd follow-up)

  Baseline and 24 months (2nd follow-up)

• Change from Baseline in waist circumference [WC] at 12 months (1st follow-up)

  Baseline and 12 months (1st follow-up)

Other Outcomes (2)

• Change form Baseline in the BMI z-score of children at 12 months (1st follow-up)

  Baseline and 12 months (1st follow-up)

• Change form Baseline in the BMI z-score of children at 24 months (2nd follow-up)

  Baseline and 24 months (2nd follow-up)

Study Arms (4)

Intermediate hyperglycaemia DC4Y intervention group

EXPERIMENTAL

Participants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care

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

Behavioral: mHealth self-management intervention

Intermediate hyperglycaemia enhanced standard care group

ACTIVE COMPARATOR

Participants will receive enhanced standard care, including lifestyle recommendations

Behavioral: Standard care

T2DM enhanced standard care group

ACTIVE COMPARATOR

Participants will receive enhanced standard care, including lifestyle recommendations

Behavioral: Standard care

Interventions

mHealth self-management intervention BEHAVIORAL

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).

Intermediate hyperglycaemia DC4Y intervention group; T2DM DC4Y intervention group

Standard care BEHAVIORAL

Participants will receive standard care, including lifestyle recommendations.

Intermediate hyperglycaemia enhanced standard care group; T2DM enhanced standard care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Universiteti i Mjekësisë

Tirana, Rruga E Dibrës, AL1005, Albania

Location

Medical University of Varna

Varna, Varna, 9002, Bulgaria

Location

Harokopio University

Athens, Attica, 17676, Greece

Location

Universidad de Zaragoza

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (13)

• 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.

  PMID: 32164646 BACKGROUND

• Manios 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.

  PMID: 30207513 BACKGROUND

• Lindstrom 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.

  PMID: 12610029 BACKGROUND

• Mavrogianni 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.

  PMID: 30796939 BACKGROUND

• Oldenburg 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.

  PMID: 25581147 BACKGROUND

• O'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.

  PMID: 28339628 BACKGROUND

• Siopis 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.

  PMID: 36828607 RESULT

• Moschonis 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.

  PMID: 36828606 RESULT

• Willems 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.

  PMID: 37596488 RESULT

• Seghieri 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.

  PMID: 38573190 RESULT

• Tortu 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.

  PMID: 40986459 RESULT

• Seghieri 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.

  PMID: 41675093 RESULT

• Vitoratou 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.

  PMID: 41794157 RESULT

Related Links

• DigiCare4You link website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Hypertension; Obesity; Overweight; Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yannis Manios, Professor

  Harokopio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 13, 2022
• Study Start: October 1, 2022
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (1); BU (1); GR (1); AL (1)