search
Back to results

Personalized Follow-up Program in the Type 2 Diabetes Prevention (PROXIPART)

Primary Purpose

Type2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized care program
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2 Diabetes focused on measuring Diabetes, Metabolic Diseases, Endocrine System Diseases, Prevention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Person with a FINDRISC score ≥ 10 points
  • Person who has given his/her express written and informed consent

Exclusion Criteria:

- Person already diagnosed with a type 2 diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    With a personalized care program

    Without a personalized care program

    Arm Description

    The strategy implemented is a personalized care pathway that includes participant follow-up by a nurse for 5 years with contact every 4 months for the first year, then every 6 months

    The comparison strategy does not include any specific management. The patient will not receive individualized management with the nurse coordinator.

    Outcomes

    Primary Outcome Measures

    Risk factors for type 2 diabetes in participants
    Finnish Diabetes Risk Score (FINDRISC score) : 8 items with a total score from 0 to 26 points with 0 (no risk factor) and 26 (highest risk factor)

    Secondary Outcome Measures

    Diabetes diagnostic
    measuring fasting blood glucose
    The Quality of Life
    WHO questionary : total score out of 100, 26 questions with 5 likert scale items
    program compliance
    Compliance is based on all the scheduled visits, the number of visits not carried out and the time during the research will be described in each group.

    Full Information

    First Posted
    May 25, 2021
    Last Updated
    September 14, 2021
    Sponsor
    GCS Ramsay Santé pour l'Enseignement et la Recherche
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04907760
    Brief Title
    Personalized Follow-up Program in the Type 2 Diabetes Prevention
    Acronym
    PROXIPART
    Official Title
    Personalized Follow-up Program in the Type 2 Diabetes Prevention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 10, 2021 (Anticipated)
    Primary Completion Date
    October 10, 2026 (Anticipated)
    Study Completion Date
    October 10, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GCS Ramsay Santé pour l'Enseignement et la Recherche

    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 global prevalence of diabetes was estimated to 5% of the population in 2016, the type two diabetes (DT2) corresponding to 90% of cases. This number is widely underestimated because most people are untreated and undiagnosed. Due to the silent character of this disease, it is estimated that 20 à 30 % of diabetic adults have not yet been diagnosed. The conclusions, presented during the annual meeting of EASD in 2019, suggest that the precursor signs of this disease could be present until 20 years before the diagnosis. Diabetes is a metabolic disease and people are diagnosed, in general, around 40-50 years old. The main risk factor of type II diabetes is lifestyle (rich diet, sedentary) but there is also other factors like hyperlipidemia, high blood pressure, high fasting blood sugar, stress, smoking, heredity, family history of diabetes, or gestational diabetes. This induces an increase of obesity, itself a major risk factor for type II diabetes occurrence. From an economical aspect, chronic pathologies (including diabetes) represent 60% of health insurance expenses, even though it concerns 35% of insured persons, i.e. 20 million of patients. The average of annual reimbursement for a type 2 diabetic patient is 4890 euros. In this context, this study is the first step of thinking about a different, coordinated care approach, based on a preventive rather than curative approach.
    Detailed Description
    This study includes a personalized care program, including the patient follow-up by a nurse during 5 years with a contact every 4 months for the first year, then after every 6 months. The nurse will review the patient's progress and provide advice and contact with professionals: physical activity, psychologists, dieticians, endocrinologists, etc The main objective of this study is to compare, after 5 years of follow-up, the risk factors associated with type 2 diabetes, between participants who received personalized follow-up and those who did not. The secondary objectives are to compare the occurrence of type 2 diabetes, the quality of life and the compliance to the program between participants who received personalized follow-up and those who did not.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type2 Diabetes
    Keywords
    Diabetes, Metabolic Diseases, Endocrine System Diseases, Prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Interventional, prospective, randomized, controlled, two arms, multicentric study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    230 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    With a personalized care program
    Arm Type
    Experimental
    Arm Description
    The strategy implemented is a personalized care pathway that includes participant follow-up by a nurse for 5 years with contact every 4 months for the first year, then every 6 months
    Arm Title
    Without a personalized care program
    Arm Type
    No Intervention
    Arm Description
    The comparison strategy does not include any specific management. The patient will not receive individualized management with the nurse coordinator.
    Intervention Type
    Other
    Intervention Name(s)
    Personalized care program
    Intervention Description
    It includes the participant follow-up by a nurse during 5 years with a contact every 4 months for the first year, then after every 6 months
    Primary Outcome Measure Information:
    Title
    Risk factors for type 2 diabetes in participants
    Description
    Finnish Diabetes Risk Score (FINDRISC score) : 8 items with a total score from 0 to 26 points with 0 (no risk factor) and 26 (highest risk factor)
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Diabetes diagnostic
    Description
    measuring fasting blood glucose
    Time Frame
    at 5 years
    Title
    The Quality of Life
    Description
    WHO questionary : total score out of 100, 26 questions with 5 likert scale items
    Time Frame
    at 5 years
    Title
    program compliance
    Description
    Compliance is based on all the scheduled visits, the number of visits not carried out and the time during the research will be described in each group.
    Time Frame
    during 5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Person with a FINDRISC score ≥ 10 points Person who has given his/her express written and informed consent Exclusion Criteria: - Person already diagnosed with a type 2 diabetes
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aurelie LIETAER, MD
    Phone
    33 (0)5 59 57 75 60
    Email
    a.lietaer@yahoo.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aurelie LIETAER, MD
    Organizational Affiliation
    Clinique Aguilera-RGDS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Personalized Follow-up Program in the Type 2 Diabetes Prevention

    We'll reach out to this number within 24 hrs