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

NCT ID: NCT05629221

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-30
• Study Completion Date: 2024-09-30

Brief Summary

The goal of this randomised trial is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organizational asset for poorly controlled type 2 diabetes individuals in the Autonomous Province of Trento (PAT). The main question aims to answer whether individuals using the "TreC Diabete" platform will improve their haemoglobin glycated level (Hb1Ac) at 12-month post-randomisation. Participants will be asked to perform some tasks and to share their data with the healthcare staff members through the platform. Control group will receive standard care.

Detailed Description

Type 2 diabetes mellitus (T2DM) is a non-communicable disease representing one of the most serious public health challenges of the 21st 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 effective in helping some individuals manage their long-term diseases. Therefore, it has the potential to reduce health service utilization 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 organizational asset targeting poorly controlled T2DM individuals in the Autonomous Province of Trento (PAT), Italy.This trial was designed as a multi-center, open-label, randomised, superiority study with two parallel-groups and a 1:1 allocation ratio. Individuals regularly attending outpatients diabetes clinics, providing informed consent are randomised to be prescribed TreC Diabete platform or not 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.This trial is the first conducted in the PAT 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 organizational 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.

Conditions

Diabetes type2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TreC Diabete App users

Sixty individuals allocated to the intervention group are prescribed with the TreC Diabete App for 12 months, one of the App created within the so-called TreC platform, which enables citizens from PAT to access, manage and share information about their health and wellbeing in the context of telemedicine. The use of the App is additional to the standard care, based on the integrated preventive and diagnostic care pathway (called "Percorsi Preventivi Diagnostici Terapeutici Assistenziali - PPDTA" in Italian).An appointment with the outpatient diabetes clinic staff is scheduled at 6 and 12 month from the first visit (taking place within 30 days of the study entry), either through telemedicine (remote visit) or face-to-face.

Group Type: EXPERIMENTAL

TreC Diabete App

Intervention Type: OTHER

Participants can download the App from Google Play or Apple Store and activate the App as soon as the clinician provides them a unique activation code, created through an online medical dashboard. The dashboard allows the interaction between healthcare staff and the participant through the use of a chat or a video-chat. Participants are asked to register some information in the App at set times (e.g. blood pressure). Reminders are periodically sent to remember the participants to perform some tasks. Clinicians will periodically check the information entered by the participant (min frequency 45 days).

non-App users

Sixty individuals are allocated to the control group. These participants will receive standard care, which is the best care for T2DM in line with the integrated preventive and diagnostic care pathway (called "Percorsi Preventivi Diagnostici Terapeutici Assistenziali - PPDTA" in Italian).An appointment with the outpatient diabetes clinic staff is scheduled at 6 and 12 month from the first visit (taking place within 30 days of the study entry), either through telemedicine (remote visit) or face-to-face. Participants are asked to register their data as per routine (e.g. paper diary).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TreC Diabete App

Participants can download the App from Google Play or Apple Store and activate the App as soon as the clinician provides them a unique activation code, created through an online medical dashboard. The dashboard allows the interaction between healthcare staff and the participant through the use of a chat or a video-chat. Participants are asked to register some information in the App at set times (e.g. blood pressure). Reminders are periodically sent to remember the participants to perform some tasks. Clinicians will periodically check the information entered by the participant (min frequency 45 days).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• being diagnosed with T2DM;
• aged ≥ 18 and ≤ 85 years old;
• having an HbA1c level >7% (53 mmol/mol) and <12% (108 mmol/mol);
• being able to walk without walking aids;
• having provided written informed consent;
• having a smartphone or a tablet and being able to download the App that will be used to insert the required data.

Exclusion Criteria

• having a BMI <18 Kg/m² and >45 Kg/m²;
• having a sBP <100 or >200 mmHg and/or dBP <50 or >120 mmHg;
• being diagnosed with a stage 5 CKD*
• being diagnosed with a NYHA stage IV;
• poor collaboration (ie unwilling to modify the actual plan of control and therapy, even if not ideal) for which adherence to the study is unlikely
• having no possibility of using a smartphone or a tablet
• having medical conditions affecting the study participation (i.e. life expectancy < 1 year)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Bruno Kessler

OTHER

Sponsor Role: collaborator

Provincia Autonoma di Trento

OTHER_GOV

Sponsor Role: collaborator

TrentinoSalute4.0

OTHER

Sponsor Role: collaborator

Ministero della Salute, Italy

OTHER

Sponsor Role: collaborator

Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento

OTHER

Sponsor Role: lead

Responsible Party

Inchiostro Sandro

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandro Inchiostro

Role: PRINCIPAL_INVESTIGATOR

Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento

Locations

Azienda Provinciale per i Servizi Sanitari

Trento, Trentino-Alto Adige, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alexia Giovanazzi

Role: CONTACT

alexia.giovanazzi@apss.tn.it

+39 0464403398

Facility Contacts

Alexia Giovanazzi

Role: primary

alexia.giovanazzi@apss.tn.it

References

Giovanazzi A, Gios L, Mastellaro M, Gentilini MA, 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. 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. 2023 Aug 10;24(1):513. doi: 10.1186/s13063-023-07515-6.

Reference Type: DERIVED

PMID: 37563665 (View on PubMed)

Other Identifiers

NET-2018-12367206 - WP4

Identifier Type: OTHER

Identifier Source: secondary_id

Telemechron - A765

Identifier Type: -

Identifier Source: org_study_id