Clinical 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes type2
Keywords: telemedicine
smartphone
mHealth
mobile applications
Lead sponsor: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
Sponsor class: OTHER
Collaborators: name: Fondazione Bruno Kessler
name: Provincia Autonoma di Trento
name: TrentinoSalute4.0
name: Ministero della Salute, Italy
First posted: 2022-11-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Haemoglobin glycated (Hb1Ac) mean changes
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of participants with Hb1Ac <53mmol/mol
timeFrame: 12 months
measure: Hb1Ac mean changes
timeFrame: 3 months, 6 months and 9 months
measure: Number of hypoglycemic episodes
timeFrame: 12 months
measure: Number of subjects reaching targeted lipid profile
timeFrame: 12 months
measure: Number of subjects reaching targeted blood pressure levels
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Effect on weight
timeFrame: 3 months, 6 months, 9 months and 12 months
measure: Level of physical activity
timeFrame: 3 months, 6 months, 9 months and 12 months
measure: Quality of life score changes
timeFrame: 12 months
measure: Satisfaction and usability score of the App
timeFrame: 12 months
measure: Number of telemedicine visits between participants and nurses/clinicians and chat interactions
timeFrame: 3 months, 6 months, 9 months and 12 months
measure: Number of (tele)specialist consultations
timeFrame: 3 months, 6 months, 9 months and 12 months
measure: Number of changes in the therapeutic plan
timeFrame: 3 months, 6 months, 9 months and 12 months
measure: Time spent for telemedicine visits
timeFrame: 6 months
Other outcomes:
Locations:
city: Trento
country: Italy
facility: Azienda Provinciale per i Servizi Sanitari
state: Trentino-Alto Adige
Study officials:
affiliation: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
name: Sandro Inchiostro
role: PRINCIPAL_INVESTIGATOR
References: