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 (Telemechron)

July 19, 2023 updated by: Inchiostro Sandro, Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Trentino-Alto Adige
      • Trento, Trentino-Alto Adige, Italy, 38122
        • Recruiting
        • Azienda Provinciale Per I Servizi Sanitari
        • Contact:
        • Principal Investigator:
          • Sandro Inchiostro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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).
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Haemoglobin glycated (Hb1Ac) mean changes
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants with Hb1Ac <53mmol/mol
Time Frame: 12 months
Proportion of participants with Hb1Ac <53mmol/mol within the two arms
12 months
Hb1Ac mean changes
Time Frame: 3 months, 6 months and 9 months
Difference in the participants' HbA1c level at different time frame other than at 12 months
3 months, 6 months and 9 months
Number of hypoglycemic episodes
Time Frame: 12 months
Frequency of hypoglycemic episodes within the two arms
12 months
Number of subjects reaching targeted lipid profile
Time Frame: 12 months
Proportion of participants reaching the targeted lipid profile (LDL level <70 mg/dl and non-HDL cholesterol level <100 mg/dl)
12 months
Number of subjects reaching targeted blood pressure levels
Time Frame: 3 months, 6 months, 9 months, 12 months
Proportion of participants reaching the targeted BP levels (sBP <130mmHg or <140 if ≥65 years old) and dBP <80mmHg)
3 months, 6 months, 9 months, 12 months
Effect on weight
Time Frame: 3 months, 6 months, 9 months and 12 months
Effect on weight for the app users
3 months, 6 months, 9 months and 12 months
Level of physical activity
Time Frame: 3 months, 6 months, 9 months and 12 months
Information collected through specific questionnaires
3 months, 6 months, 9 months and 12 months
Quality of life score changes
Time Frame: 12 months
Changes in quality of life scores for participants of both arms through a specific questionnaire
12 months
Satisfaction and usability score of the App
Time Frame: 12 months
Satisfaction and usability score of the App in the intervention group only
12 months
Number of telemedicine visits between participants and nurses/clinicians and chat interactions
Time Frame: 3 months, 6 months, 9 months and 12 months
Process indicator outcome
3 months, 6 months, 9 months and 12 months
Number of (tele)specialist consultations
Time Frame: 3 months, 6 months, 9 months and 12 months
Process indicator outcome
3 months, 6 months, 9 months and 12 months
Number of changes in the therapeutic plan
Time Frame: 3 months, 6 months, 9 months and 12 months
Process indicator outcome: number of changes in the therapeutic plan (e.g. drug prescription and dosage)
3 months, 6 months, 9 months and 12 months
Time spent for telemedicine visits
Time Frame: 6 months
Process indicator outcome: amount of time spent for telemedicine visits (calculated on the basis of the average time spent to deliver eight consecutive nursing visits and eight consecutive medical visits)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministero della Salute, Italy
Fondazione Bruno Kessler
Provincia Autonoma di Trento
TrentinoSalute4.0

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandro Inchiostro, Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Telemechron - A765
  • NET-2018-12367206 - WP4 (Other Identifier: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will not be available on an individual level. We plan to share data on their aggregated form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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