Predictive Model on the Effect of Lifestyles in the Management of T2D (GK_T2D)

January 27, 2023 updated by: Casa Sollievo della Sofferenza IRCCS

Observational Analysis and Elaboration of a Predictive Model on the Effects of Physical Activity and Individual Lifestyles in the Management of Diabetic Disease Type 2 as Part of the GATEKEEPER H2020 Project.

This study aims to produce new evidence on the positive effects of physical activity and certain individual lifestyles in the control of type 2 diabetic disease. The goal is to build and evaluate the effectiveness of a new parsimonious risk prediction model based on the use of classical variables (blood exams), already used in other models for predicting the risk related to the disease, together with measures obtained from the use of wearable devices (steps count, sleep hours, heart rate).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Scientific literature has shown that the use of wearable devices can improve the control of type 2 diabetes mellitus. The aim of the study is to develop a statistical model for the control of type 2 diabetes mellitus (DMT2) based on the use of "conventional" clinical parameters and the use of "unconventional" data from wearable devices. The medical outcome variable that will be used to measure diabetes control and model performance will be the Glycated Hemoglobin (HbA1c). The participant will receive a Samsung smartwatch (Galaxy Watch 3) and a Samsung smartphone (A51), (the latter only in case the participant is not in possession of a compatible smartphone) which he/she must wear during his daily activities and also during the night to measure daily activity, sleep hours and heart rate. Casa Sollievo della Sofferenza Hospital previoulsy developted the ENFORCE calculator, an inexpensive and parsimonious prediction model of 2-year all cause mortality in real life patients with T2D. In this study the investigators aim to elaborate a standardized validated risk scores similar to what has been done for ENFORCE.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

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

Study Locations

  • Italy
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • Casa Sollievo Della Sofferenza IRCCS

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

Ages Eligible for Study

55 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 diabetes followed by Casa Sollievo della Sofferenza Hospital

Description

Inclusion Criteria:

  • Age ≥ 55 years old
  • Affected by Type 2 Diabetes and monitored by Casa Sollievo della Sofferenza Hospital
  • Basic skills in using a smartphone and its apps
  • Available to use the device and its applications
  • Ability to understand the informed consent

Exclusion Criteria:

  • Inability to understand the informed consent
  • Low life expectancy
  • Type 1 Diabetes
  • Secondary Diabetes

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TYPE 2 DIABETES
Patients affected by type 2 diabetes
Other: Standard care for T2D patients, Smartwatch
No intervention, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline HbA1c at 6 and 12 months
Time Frame: Baseline, 6 months, 12 months
Glycated Hemoglobin
Baseline, 6 months, 12 months

Collaborators and Investigators

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

Sponsor

Casa Sollievo della Sofferenza IRCCS

Investigators

  • Principal Investigator: Salvatore De Cosmo, MD, Casa Sollievo Della Sofferenza IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

June 26, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GATEKEEPER-V1.6_03 DIC 2020

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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