Clinical trial NCT05261841: Predictive Model on the Effect of Lifestyles in the Management of 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Keywords: T2D
CONSUMER DEVICES
SMARTWATCH
ARTIFICIAL INTELLIGENCE
Lead sponsor: Casa Sollievo della Sofferenza IRCCS
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes followed by Casa Sollievo della Sofferenza Hospital

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.

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

Primary outcomes:
measure: Change from Baseline HbA1c at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza IRCCS
state: FG
Study officials:
affiliation: Casa Sollievo della Sofferenza IRCCS
name: Salvatore De Cosmo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.