Impact of digital health on Type 2 diabetes management: a randomised controlled trial of the ‘TreC Diabete’ platform (TELEMECHRON Study)

BackgroundThe use of technologies in the health field has progressively increased. Within the context of a broader project funded by the Italian Ministry of Health (TELEMECHRON study), a randomised controlled trial (RCT) has been conducted in the Autonomous Province of Trento on type 2 diabetes indi...

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Main Authors: Alexia Giovanazzi, Lorenzo Gios, Maria Adalgisa Gentilini, Marina Mastellaro, Patrizia Bartolotta, Lucrezia Nicolussi Giacomaz, Claudio Eccher, Sandro Inchiostro
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Clinical Diabetes and Healthcare
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Online Access:https://www.frontiersin.org/articles/10.3389/fcdhc.2025.1589548/full
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author Alexia Giovanazzi
Lorenzo Gios
Maria Adalgisa Gentilini
Marina Mastellaro
Patrizia Bartolotta
Lucrezia Nicolussi Giacomaz
Claudio Eccher
Sandro Inchiostro
author_facet Alexia Giovanazzi
Lorenzo Gios
Maria Adalgisa Gentilini
Marina Mastellaro
Patrizia Bartolotta
Lucrezia Nicolussi Giacomaz
Claudio Eccher
Sandro Inchiostro
author_sort Alexia Giovanazzi
collection DOAJ
description BackgroundThe use of technologies in the health field has progressively increased. Within the context of a broader project funded by the Italian Ministry of Health (TELEMECHRON study), a randomised controlled trial (RCT) has been conducted in the Autonomous Province of Trento on type 2 diabetes individuals with an untargeted glycated haemoglobin (HbA1c) level.MethodsThe overall aim was to evaluate the impact of the “TreC Diabete” digital platform, including a smartphone application (app) and a dashboard. This open-label, parallel-group, 1:1 allocation ratio RCT in which the intervention group used the app for data entry, symptoms questionnaire, communication with healthcare staff and medication recording, while the control group received standard care. The primary endpoint was change in HbA1c levels at 12 months between groups.ResultsBetween December 2022 and August 2023, 103 participants were enrolled (51 intervention; 52 control), with a median age of 67 years old, time from diabetes diagnosis to enrolment 13 years, and 72% male. At 12 months, the median change in HbA1c levels did not differ significantly between groups. Regarding app usage, data entries decreased significantly from the first quarter to the second quarter but subsequently stabilised (p = 0.001). System usability (from 42 responders in the intervention group) had a median score of 95 (range: 0–100), indicating a high level of satisfaction with the platform.DiscussionThe study faced several challenges, including platform technical issues, service interruption, data entry anomalies and difficulties in participant recruitment. Study generalisability may be limited by the sample’s demographics, as the trial predominantly included younger male individuals with a specific HbA1c level.ConclusionThe study highlighted key factors for future implementations, including understanding technology benefits, addressing adoption barriers, and providing education and support to both patients and healthcare providers.
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spelling doaj-art-91a383bb3ab34a67b5e6afd21a53f7692025-08-20T02:23:27ZengFrontiers Media S.A.Frontiers in Clinical Diabetes and Healthcare2673-66162025-06-01610.3389/fcdhc.2025.15895481589548Impact of digital health on Type 2 diabetes management: a randomised controlled trial of the ‘TreC Diabete’ platform (TELEMECHRON Study)Alexia Giovanazzi0Lorenzo Gios1Maria Adalgisa Gentilini2Marina Mastellaro3Patrizia Bartolotta4Lucrezia Nicolussi Giacomaz5Claudio Eccher6Sandro Inchiostro7Servizio Governance Clinica, Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento, Trento, ItalyTrentinoSalute4.0, Competence Center for Digital Health, Trento, Provincia Autonoma di Trento, ItalyUnità Operativa epidemiologica clinica e valutativa, Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento, Trento, Provincia Autonoma di Trento, ItalyServizio Governance Clinica, Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento, Trento, ItalyUnità Operativa epidemiologica clinica e valutativa, Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento, Trento, Provincia Autonoma di Trento, ItalyDigital Health Innovation Lab Unit, Fondazione Bruno Kessler, Trento, Provincia Autonoma di Trento, ItalyDigital Health Innovation Lab Unit, Fondazione Bruno Kessler, Trento, Provincia Autonoma di Trento, ItalyDipartimento medico, Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento, Trento, ItalyBackgroundThe use of technologies in the health field has progressively increased. Within the context of a broader project funded by the Italian Ministry of Health (TELEMECHRON study), a randomised controlled trial (RCT) has been conducted in the Autonomous Province of Trento on type 2 diabetes individuals with an untargeted glycated haemoglobin (HbA1c) level.MethodsThe overall aim was to evaluate the impact of the “TreC Diabete” digital platform, including a smartphone application (app) and a dashboard. This open-label, parallel-group, 1:1 allocation ratio RCT in which the intervention group used the app for data entry, symptoms questionnaire, communication with healthcare staff and medication recording, while the control group received standard care. The primary endpoint was change in HbA1c levels at 12 months between groups.ResultsBetween December 2022 and August 2023, 103 participants were enrolled (51 intervention; 52 control), with a median age of 67 years old, time from diabetes diagnosis to enrolment 13 years, and 72% male. At 12 months, the median change in HbA1c levels did not differ significantly between groups. Regarding app usage, data entries decreased significantly from the first quarter to the second quarter but subsequently stabilised (p = 0.001). System usability (from 42 responders in the intervention group) had a median score of 95 (range: 0–100), indicating a high level of satisfaction with the platform.DiscussionThe study faced several challenges, including platform technical issues, service interruption, data entry anomalies and difficulties in participant recruitment. Study generalisability may be limited by the sample’s demographics, as the trial predominantly included younger male individuals with a specific HbA1c level.ConclusionThe study highlighted key factors for future implementations, including understanding technology benefits, addressing adoption barriers, and providing education and support to both patients and healthcare providers.https://www.frontiersin.org/articles/10.3389/fcdhc.2025.1589548/fulltype 2 diabetesmetabolic controlrandomised controlled trialmHealthtelemedicinedigital health
spellingShingle Alexia Giovanazzi
Lorenzo Gios
Maria Adalgisa Gentilini
Marina Mastellaro
Patrizia Bartolotta
Lucrezia Nicolussi Giacomaz
Claudio Eccher
Sandro Inchiostro
Impact of digital health on Type 2 diabetes management: a randomised controlled trial of the ‘TreC Diabete’ platform (TELEMECHRON Study)
Frontiers in Clinical Diabetes and Healthcare
type 2 diabetes
metabolic control
randomised controlled trial
mHealth
telemedicine
digital health
title Impact of digital health on Type 2 diabetes management: a randomised controlled trial of the ‘TreC Diabete’ platform (TELEMECHRON Study)
title_full Impact of digital health on Type 2 diabetes management: a randomised controlled trial of the ‘TreC Diabete’ platform (TELEMECHRON Study)
title_fullStr Impact of digital health on Type 2 diabetes management: a randomised controlled trial of the ‘TreC Diabete’ platform (TELEMECHRON Study)
title_full_unstemmed Impact of digital health on Type 2 diabetes management: a randomised controlled trial of the ‘TreC Diabete’ platform (TELEMECHRON Study)
title_short Impact of digital health on Type 2 diabetes management: a randomised controlled trial of the ‘TreC Diabete’ platform (TELEMECHRON Study)
title_sort impact of digital health on type 2 diabetes management a randomised controlled trial of the trec diabete platform telemechron study
topic type 2 diabetes
metabolic control
randomised controlled trial
mHealth
telemedicine
digital health
url https://www.frontiersin.org/articles/10.3389/fcdhc.2025.1589548/full
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