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

Type 2 Diabetes Clinical Trial

— GK_T2D  

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05261841
• Other study ID #: GATEKEEPER-V1.6_03 DIC 2020
• Status: Active, not recruiting
• Start date: June 26, 2021
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: Casa Sollievo della Sofferenza IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Other:
• Standard care for T2D patients, Smartwatch
No intervention, observational study

Locations

Country	Name	City	State
Italy	Casa Sollievo della Sofferenza IRCCS	San Giovanni Rotondo	FG

Sponsors (1)

Lead Sponsor	Collaborator
Casa Sollievo della Sofferenza IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline HbA1c at 6 and 12 months	Glycated Hemoglobin	Baseline, 6 months, 12 months

External Links

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