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

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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05261841
Acronym
GK_T2D
Enrollment
100
Registered
2022-03-02
Start date
2021-06-26
Completion date
2023-06-30
Last updated
2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

T2D, CONSUMER DEVICES, SMARTWATCH, ARTIFICIAL INTELLIGENCE

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.

Interventions

OTHERStandard care for T2D patients, Smartwatch

No intervention, observational study

Sponsors

Casa Sollievo della Sofferenza IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline HbA1c at 6 and 12 monthsBaseline, 6 months, 12 monthsGlycated Hemoglobin

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026