NCT05629221

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

November 17, 2022

Last Update Submit

July 19, 2023

Conditions

Diabetes type2

Keywords

telemedicinesmartphonemHealthmobile applications

Outcome Measures

Primary Outcomes (1)

  • Haemoglobin glycated (Hb1Ac) mean changes

    Difference in the participants' HbA1c level between the two arms. Blood test carried out by qualified nurses and processes by the local analysis laboratory. Blood tests results are automatically registered on the Hospital Information System (HIS) and reviewed by clinicians and research staff involved in the study.

    12 months

Secondary Outcomes (13)

  • Proportion of participants with Hb1Ac <53mmol/mol

    12 months

  • Hb1Ac mean changes

    3 months, 6 months and 9 months

  • Number of hypoglycemic episodes

    12 months

  • Number of subjects reaching targeted lipid profile

    12 months

  • Number of subjects reaching targeted blood pressure levels

    3 months, 6 months, 9 months, 12 months

  • +8 more secondary outcomes

Study Arms (2)

TreC Diabete App users

EXPERIMENTAL

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.

Other: TreC Diabete App

non-App users

NO INTERVENTION

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).

Interventions

TreC Diabete AppOTHER

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).

TreC Diabete App users

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Provinciale per i Servizi Sanitari

Trento, Trentino-Alto Adige, 38122, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37563665DERIVED

Study Officials

  • Sandro Inchiostro

    Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexia Giovanazzi

CONTACT

+39 0464403398alexia.giovanazzi@apss.tn.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 17, 2022

First Posted

November 29, 2022

Study Start

December 30, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

IT(1)