NCT05110625: preDIABETEXT

mHealth Intervention to Prevent Type 2 Diabetes Mellitus (Phase II Study)

Completed NA Last updated 23 August 2024

What this trial tests

NA trial testing preDIABE-TEXT in Prediabetic State in 365 participants. Completed in 31 May 2023.

Timeline

1 December 2021

Primary endpoint
31 May 2023

31 May 2023

Quick facts

Lead sponsor	Fundació d'investigació Sanitària de les Illes Balears
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	365
Start date	1 December 2021
Primary completion	31 May 2023
Estimated completion	31 May 2023
Sites	1 location across Spain

Drugs / interventions tested

• preDIABE-TEXT
• Online Education

Conditions studied

• Prediabetic State — all drugs for Prediabetic State →

Sponsor

Fundació d'investigació Sanitària de les Illes Balears

Who can join

Adults 18 to 75, any sex, with Prediabetic State. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to develop and evaluate a low intensity, multifaceted, digital health intervention to prevent T2DM based on: i) the use of a system comprising mobile health (mHealth) technology integrated with electronic health records to send tailored text messages (SMSs) promoting lifestyle changes in people at risk of T2DM, and, ii) the provision of online education to primary healthcare workers about prediabetes management.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development and Evaluation of a Digital Health Intervention to Prevent Type 2 Diabetes in Primary Care: The PREDIABETEXT Study Protocol for a Randomised Clinical Trial.
   Galmes-Panades AM, Angullo E, Mira-Martínez S, Bennasar-Veny M, et al · · 2022 · cited 3× · PMID 36429423 · DOI 10.3390/ijerph192214706
2. Describing the initial results of a pragmatic, cluster randomized clinical trial to examine the impact of a multifaceted digital intervention for the prevention of type 2 diabetes mellitus in the primary care setting: intervention design, recruitment strategy and participants' ba
   Mira-Martínez S, Zamanillo-Campos R, Malih N, Fiol-deRoque MA, et al · · 2025 · cited 2× · PMID 40230484 · DOI 10.3389/fendo.2025.1524336
3. A Multifaceted Digital Intervention for the Prevention of Type 2 Diabetes Mellitus in Primary Care (PREDIABETEXT): Cluster Randomized Trial.
   Mira-Martínez S, Malih N, Angullo-Martínez E, Zamanillo-Campos R, et al · · 2025 · PMID 41067715 · DOI 10.2196/70981