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
About this trial
This is an interventional prevention trial for Type2 Diabetes focused on measuring Diabetes, Metabolic Diseases, Endocrine System Diseases, Prevention
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
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
NCT ID
NCT04907760
First Posted
May 25, 2021
Last Updated
September 14, 2021
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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
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Personalized Follow-up Program in the Type 2 Diabetes Prevention
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