Evidence map›Paper›PMID 37563665›Full record

ArticleTrials2023

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).

Alexia Giovanazzi, Lorenzo Gios, Marina Mastellaro, Maria Adalgisa Gentilini, Francesca Valent, Sara Condini, Giorgia Bincoletto, Alessandro Bacchiega, Andrea Zorzi, Giulia Malfatti and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05629221 (Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05629221 naunknown statusnot on this map

Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values

TypeinterventionalSponsorAzienda Sanitaria Universitaria Integrata del TrentinoRan2022 to 2024Enrolled120ConditionsDiabetes type2ArmsTreC Diabete App
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Observational
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 1 country.

Alexia GiovanazziAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di Trento, Trento, Italy.
Lorenzo GiosTrentinoSalute4.0, Competence Center for Digital Health, Trento, Italy.
Marina MastellaroAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di Trento, Trento, Italy.
Maria Adalgisa GentiliniAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di Trento, Trento, Italy.
Francesca ValentServizio di Igiene e Sanità Pubblica, Dipartimento di Prevenzione, Azienda sanitaria universitaria Friuli Centrale, Gemona del Friuli, Italy.
Sara CondiniAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di Trento, Trento, Italy.
Giorgia BincolettoFacoltà Di Giurisprudenza, Università Degli Studi Di Trento, Trento, Italy.
Alessandro BacchiegaFondazione Bruno Kessler, Trento, Italy.
Andrea ZorziFondazione Bruno Kessler, Trento, Italy.
Giulia MalfattiTrentinoSalute4.0, Competence Center for Digital Health, Trento, Italy.
Francesca PeriniTrentinoSalute4.0, Competence Center for Digital Health, Trento, Italy.
Claudio EccherFondazione Bruno Kessler, Trento, Italy.
Michele MarchesoniFondazione Bruno Kessler, Trento, Italy.
Marlene Dall'AldaAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di Trento, Trento, Italy.
Massimo OrraschAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di Trento, Trento, Italy.
Diego ConfortiProvincia Autonoma Di Trento, Trento, Italy.
Sandro InchiostroAzienda Provinciale Per I Servizi Sanitari, Provincia Autonoma Di Trento, Trento, Italy. sandro.inchiostro@apss.tn.it.
Provincia Autonoma di Trento · ITFondazione Bruno Kessler · ITUniversity of Trento · IT

Funding

Department of Health of the Italian National Health System NET-2018-12367206
6 · The paper itself

Abstract

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

Indexed as

Diabetes Mellitus, Type 2Mobile ApplicationsEquivalence Trials as TopicHumansItalyModels, OrganizationalMulticenter Studies as TopicRandomized Controlled Trials as TopicTechnologymHealthMobile applicationSmartphoneTechnologyTelemedicineType 2 diabetes mellitus

Identifiers

PMID37563665
PMCPMC10413726
OpenAlexW4385740300

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.