Organisational models supported by technology for the management of diabetic disease and its complications in a diabetic clinic setting study protocol for a randomised controlled trial targeting type 2 diabetes individuals with non-ideal glycaemic values (Telemechron study)
Open accessAbstract
Introduction: Type 2 diabetes mellitus (T2DM) is a non-communicable disease representing one of the most serious public health challenges of the twenty-first century. Its incidence continues to rise in both developed and developing countries, causing the death of 1.5 million people every year. The use of technology (e.g. smartphone application—App) in the health field has progressively increased as it has been proved to be effective in helping individuals manage their long-term diseases. Therefore, it has the potential to reduce the use of health service and its related costs. The objective of this study is to evaluate the impact of using a digital platform called “TreC Diabete” embedded into a novel organisational asset targeting poorly controlled T2DM individuals in the Autonomous Province of Trento (PAT), Italy. Methods: This trial was designed as a multi-centre, open-label, randomised, superiority study with two parallel groups and a 1:1 allocation ratio. Individuals regularly attending outpatient diabetes clinics, providing informed consent, are randomised to be prescribed TreC Diabete platform as part of their personalised care plan. Healthcare staff members will remotely assess the data shared by the participants through the App by using a dedicated online medical dashboard. The primary end-point is the evaluation of the Hb1Ac level at 12-month post-randomisation. Data will be analysed on an intention-to-treat (ITT) basis. Discussion: This trial is the first conducted in the PAT area for the use of an App specifically designed for individuals with poorly controlled T2DM. If the effects of introducing this specific App within a new organisational asset are positive, the digital platform will represent a possible way for people diagnosed with T2DM to better manage their health in the future. Results will be disseminated through conferences and peer-reviewed journals once the study is completed. Trial registration: ClinicalTrials.gov NCT05629221. Registered on November 29, 2022, prior start of inclusion.
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The protocol was published in Trials BMC under the title "Organisational models supported by technology for the management of diabetic disease and its complications in a diabetic clinical setting: study protocol for a randomized controlled trial targeting type 2 diabetes individuals with non -ideal glycaemic values (Telemechron study)" and is accessible at the given link.
“The protocol was also published in Trials BMC under the title “Organisational models supported by technology for the management of diabetic disease and its complications in a diabetic clinical setting: study protocol for a randomized controlled trial targeting type 2 diabetes individuals with non -ideal glycaemic values (Telemechron study) and is accessible at this link: https://trialsjournal.biom”
From Impact of digital health on Type 2 diabetes management: a randomised controlled trial of the ‘TreC Diabete’ platform (TELEMECHRON Study) (2025) · cites this paper as [11]
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Giovanazzi, A., Gios, L., Gentilini, M. A., Mastellaro, M., Bartolotta, P., Nicolussi Giacomaz, L., Eccher, C., & Inchiostro, S. (2025) · Frontiers in Clinical Diabetes and Healthcare · doi:10.3389/fcdhc.2025.1589548 · Cited by 2 · see citing works
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- Authors
- Giovanazzi, A., Gios, L., Mastellaro, M., Gentilini, M. A., Valent, F., Condini, S., Bincoletto, G., Bacchiega, A., Zorzi, A., Malfatti, G., Perini, F., Eccher, C., Marchesoni, M., Dall’Alda, M., Orrasch, M., Conforti, D., & Inchiostro, S.
- Affiliations
- Provincia Autonoma di Trento (IT)
- Azienda sanitaria universitaria Friuli Centrale (IT)
- University of Trento (IT)
- Fondazione Bruno Kessler (IT)
- Corresponding author
- Inchiostro, Sandro
- ORCID
- Venue
- Trials
- Published
- 2023-08-10
- Volume
- 24
- Issue
- 1
- Pages
- 513-513
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC10413726
- OpenAlex
- W4385740300
- Cited by
- 4
- References
- 30
- Citations by year
- 2025: 3 · 2024: 1
- FWCI
- 1.42
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Iris (University of Trento) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Department of Health of the Italian National Health System (NET-2018-12367206)
- Provincia Autonoma di Trento
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- type 2 diabetes, uncontrolled diabetes, digital health platforms, mobile application, HbA1c, diabetes self-management, remote patient monitoring, diabetes outpatient clinic, telemedicine, health care organization, individualized care plans
- MeSH terms
- Equivalence Trials as Topic, Diabetes Mellitus, Type 2, Humans, Italy, Technology, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Models, Organizational, Mobile Applications
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