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)
Abstract 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 yea...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-08-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07515-6 |
| _version_ | 1797451536618487808 |
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| author | Alexia Giovanazzi Lorenzo Gios Marina Mastellaro Maria Adalgisa Gentilini Francesca Valent Sara Condini Giorgia Bincoletto Alessandro Bacchiega Andrea Zorzi Giulia Malfatti Francesca Perini Claudio Eccher Michele Marchesoni Marlene Dall’Alda Massimo Orrasch Diego Conforti Sandro Inchiostro |
| author_facet | Alexia Giovanazzi Lorenzo Gios Marina Mastellaro Maria Adalgisa Gentilini Francesca Valent Sara Condini Giorgia Bincoletto Alessandro Bacchiega Andrea Zorzi Giulia Malfatti Francesca Perini Claudio Eccher Michele Marchesoni Marlene Dall’Alda Massimo Orrasch Diego Conforti Sandro Inchiostro |
| author_sort | Alexia Giovanazzi |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-09T14:56:02Z |
| format | Article |
| id | doaj.art-53030b41f22e403eba3c6087ea6f02c7 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-09T14:56:02Z |
| publishDate | 2023-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-53030b41f22e403eba3c6087ea6f02c72023-11-26T14:09:56ZengBMCTrials1745-62152023-08-0124111610.1186/s13063-023-07515-6Organisational 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)Alexia Giovanazzi0Lorenzo Gios1Marina Mastellaro2Maria Adalgisa Gentilini3Francesca Valent4Sara Condini5Giorgia Bincoletto6Alessandro Bacchiega7Andrea Zorzi8Giulia Malfatti9Francesca Perini10Claudio Eccher11Michele Marchesoni12Marlene Dall’Alda13Massimo Orrasch14Diego Conforti15Sandro Inchiostro16Azienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di TrentoTrentinoSalute4.0, Competence Center for Digital HealthAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di TrentoAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di TrentoServizio di Igiene e Sanità Pubblica, Dipartimento di Prevenzione, Azienda sanitaria universitaria Friuli CentraleAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di TrentoFacoltà Di Giurisprudenza, Università Degli Studi Di TrentoFondazione Bruno KesslerFondazione Bruno KesslerTrentinoSalute4.0, Competence Center for Digital HealthTrentinoSalute4.0, Competence Center for Digital HealthFondazione Bruno KesslerFondazione Bruno KesslerAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di TrentoAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di TrentoProvincia Autonoma Di TrentoAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di TrentoAbstract 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.https://doi.org/10.1186/s13063-023-07515-6Type 2 diabetes mellitusTechnologyTelemedicinemHealthMobile applicationSmartphone |
| spellingShingle | Alexia Giovanazzi Lorenzo Gios Marina Mastellaro Maria Adalgisa Gentilini Francesca Valent Sara Condini Giorgia Bincoletto Alessandro Bacchiega Andrea Zorzi Giulia Malfatti Francesca Perini Claudio Eccher Michele Marchesoni Marlene Dall’Alda Massimo Orrasch Diego Conforti Sandro Inchiostro 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 Type 2 diabetes mellitus Technology Telemedicine mHealth Mobile application Smartphone |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Type 2 diabetes mellitus Technology Telemedicine mHealth Mobile application Smartphone |
| url | https://doi.org/10.1186/s13063-023-07515-6 |
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