Predictive Model on the Effect of Lifestyles in the Manag... | NCT05261841

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

NCT05261841

Sponsor

Casa Sollievo della Sofferenza IRCCS

Status

Unknown status

Last Update Posted

Jan 30, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Type 2 Diabetes

Interventions

Standard care for T2D patients, Smartwatch

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2021Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Feb 15, 2022

First Submission Date that Met QC Criteria

Feb 28, 2022

First Posted Date

Mar 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2023

Last Update Posted Date

Jan 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TYPE 2 DIABETES		Patients affected by type 2 diabetes	Other: Standard care for T2D patients, Smartwatch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard care for T2D patients, Smartwatch	Other	No intervention, observational study	TYPE 2 DIABETES

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with type 2 diabetes followed by Casa Sollievo della Sofferenza Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Salvatore De Cosmo, MD	Casa Sollievo della Sofferenza IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Casa Sollievo della Sofferenza IRCCS		San Giovanni Rotondo	FG	71013	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31087060	Background	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation