Predictive Model on the Effect of Lifestyles in the Management of T2D

NCT ID: NCT05261841

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-26
• Study Completion Date: 2023-06-30

Brief Summary

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).

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.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TYPE 2 DIABETES

Patients affected by type 2 diabetes

Standard care for T2D patients, Smartwatch

Intervention Type: OTHER

No intervention, observational study

Interventions

Standard care for T2D patients, Smartwatch

No intervention, observational study

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Casa Sollievo della Sofferenza IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvatore De Cosmo, MD

Role: PRINCIPAL_INVESTIGATOR

Casa Sollievo della Sofferenza IRCCS

Locations

Casa Sollievo della Sofferenza IRCCS

San Giovanni Rotondo, FG, Italy

Countries

Italy

References

Copetti M, Shah H, Fontana A, Scarale MG, Menzaghi C, De Cosmo S, Garofolo M, Sorrentino MR, Lamacchia O, Penno G, Doria A, Trischitta V. Estimation of Mortality Risk in Type 2 Diabetic Patients (ENFORCE): An Inexpensive and Parsimonious Prediction Model. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4900-4908. doi: 10.1210/jc.2019-00215.

Reference Type: BACKGROUND

PMID: 31087060 (View on PubMed)

Related Links

http://www.gatekeeper-project.eu/

This study is currently in the frame of Horizon2020 GATEKEEPER project, that is a European Multi Centric Large-Scale Pilot on Smart Living Environments.

Other Identifiers

GATEKEEPER-V1.6_03 DIC 2020

Identifier Type: -

Identifier Source: org_study_id