Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes
Proxipart
1 other identifier
interventional
230
1 country
1
Brief Summary
In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated,since it does not take into account people who are untreated or not diagnosed. However,it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis. The Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life. From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros. This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
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
March 20, 2022
CompletedFirst Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
April 13, 2022
March 1, 2022
6 years
April 5, 2022
April 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FINDRISC score
FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis.
5 years
Study Arms (2)
TD2 standard
ACTIVE COMPARATORStandard TD2 follow-up
TD2+ study Nurse
EXPERIMENTALSpecific study nurse follow-up every 4 months in addition of standard FU.
Interventions
Contact everay 4 months with a dedicated study nurse
Eligibility Criteria
You may qualify if:
- Patient, male or female, over the age of 18
- Patient with a FINDRISC score ≥10 points
- Beneficiary of a French health insurance system
- Patient having been informed and having given their consent free, enlightened and written
You may not qualify if:
- Patient over 75 years old
- Patient already diagnosed with type 2 diabetes
- Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant.
- Patient participating in another research
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration.
- Pregnant, breastfeeding or parturient women.
- Patient hospitalized without consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- European Clinical Trial Experts Networkcollaborator
Study Sites (1)
Clinique Aguiléra
Biarritz, Aquitaine, 64200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 13, 2022
Study Start
March 20, 2022
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
April 13, 2022
Record last verified: 2022-03