Predictive Model on the Effect of Lifestyles in the Management of T2D
GK_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.
1 other identifier
observational
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2021
CompletedFirst Submitted
Initial submission to the registry
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJanuary 30, 2023
January 1, 2023
1.9 years
February 15, 2022
January 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline HbA1c at 6 and 12 months
Glycated Hemoglobin
Baseline, 6 months, 12 months
Study Arms (1)
TYPE 2 DIABETES
Patients affected by type 2 diabetes
Interventions
Eligibility Criteria
Patients with type 2 diabetes followed by Casa Sollievo della Sofferenza Hospital
You may qualify if:
- 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
You may not qualify if:
- Inability to understand the informed consent
- Low life expectancy
- Type 1 Diabetes
- Secondary Diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo, FG, 71013, Italy
Related Publications (1)
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.
PMID: 31087060BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salvatore De Cosmo, MD
Casa Sollievo della Sofferenza IRCCS
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2022
First Posted
March 2, 2022
Study Start
June 26, 2021
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
January 30, 2023
Record last verified: 2023-01