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Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes (Proxipart)

Primary Purpose

Diabete Type 2

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Study nurse intervention
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabete Type 2 focused on measuring diabete type 2, preventive approach

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patient in period of exclusion from another research always in progress at the time of inclusion.
  • 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

Sites / Locations

  • Clinique AguiléraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TD2 standard

TD2+ study Nurse

Arm Description

Standard TD2 follow-up

Specific study nurse follow-up every 4 months in addition of standard FU.

Outcomes

Primary Outcome Measures

FINDRISC score
FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2022
Last Updated
April 5, 2022
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
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1. Study Identification

Unique Protocol Identification Number
NCT05325710
Brief Title
Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes
Acronym
Proxipart
Official Title
Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
April 1, 2028 (Anticipated)
Study Completion Date
April 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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, given the silent nature of the disease, it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. This share decreases with age, falling to 13% among 55-74 year olds. 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. Type 2 diabetes, or non-insulin dependent diabetes, is a metabolic disease characterized by a chronic excess of sugar in the blood, affecting both men and women. 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. The direct consequences are an increase in obesity hich is itself a major risk factor for the development of T2D. Among the risk factors, we also find hyperlipidemia, high blood pressure, high blood sugar fasting, stress, smoking, heredity, family history of diabetes, or gestational diabetes. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2
Keywords
diabete type 2, preventive approach

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Compare a group of patient with study-nurse specific regular follow-up versus standard follow-up in France
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TD2 standard
Arm Type
Active Comparator
Arm Description
Standard TD2 follow-up
Arm Title
TD2+ study Nurse
Arm Type
Experimental
Arm Description
Specific study nurse follow-up every 4 months in addition of standard FU.
Intervention Type
Behavioral
Intervention Name(s)
Study nurse intervention
Intervention Description
Contact everay 4 months with a dedicated study nurse
Primary Outcome Measure Information:
Title
FINDRISC score
Description
FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Patient in period of exclusion from another research always in progress at the time of inclusion. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JF OUDET
Phone
068346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
MH BArba
Phone
0664888704
Email
MH.Barba@ecten.eu
Facility Information:
Facility Name
Clinique Aguiléra
City
Biarritz
State/Province
Aquitaine
ZIP/Postal Code
64200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie LIETAER, DR

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes

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