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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Standard care for T2D patients, Smartwatch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TYPE 2 DIABETES<br>Patients affected by type 2 diabetes | Other: Standard care for T2D patients, Smartwatch<br>* No intervention, observational study<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CONSUMER DEVICES, SMARTWATCH, ARTIFICIAL INTELLIGENCE, T2D