An observational study in Type 2 Diabetes, sponsored by Casa Sollievo della Sofferenza IRCCS. Status unknown at 1 site in Italy. Open to participants aged 55 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Casa Sollievo della Sofferenza IRCCS · Observational
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).
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 100 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Casa Sollievo della Sofferenza IRCCS is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with type 2 diabetes followed by Casa Sollievo della Sofferenza Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients affected by type 2 diabetes
Other: Standard care for T2D patients, Smartwatch
No intervention, observational study
Change from Baseline HbA1c at 6 and 12 months
Glycated Hemoglobin
Time frame: Baseline, 6 months, 12 months
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Casa Sollievo della Sofferenza IRCCS