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)

Trials

Study Protocol

Sara Condini¹  Massimo Orrasch¹  Marlene Dall’Alda¹  Sandro Inchiostro¹  Alexia Giovanazzi¹  Maria Adalgisa Gentilini¹  Marina Mastellaro¹  Giorgia Bincoletto²  Michele Marchesoni³  Andrea Zorzi³  Alessandro Bacchiega³  Claudio Eccher³  Diego Conforti⁴  Francesca Valent⁵  Francesca Perini⁶  Giulia Malfatti⁶  Lorenzo Gios⁶ 

[1] Azienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di Trento, Trento, Italy;Facoltà Di Giurisprudenza, Università Degli Studi Di Trento, Trento, Italy;Fondazione Bruno Kessler, Trento, Italy;Provincia Autonoma Di Trento, Trento, Italy;Servizio di Igiene e Sanità Pubblica, Dipartimento di Prevenzione, Azienda sanitaria universitaria Friuli Centrale, Gemona del Friuli, Italy;TrentinoSalute4.0, Competence Center for Digital Health, Trento, Italy;

关键词: Type 2 diabetes mellitus;    Technology;    Telemedicine;    mHealth;    Mobile application;    Smartphone;   

DOI  :  10.1186/s13063-023-07515-6

 received in 2022-12-11, accepted in 2023-07-16,  发布年份 2023

来源: Springer

【 摘 要 】

IntroductionType 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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov NCT05629221. Registered on November 29, 2022, prior start of inclusion.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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