Personalized Follow-up Program in the Type 2 Diabetes Prevention

Type2 Diabetes Clinical Trial

— PROXIPART  

Official title:

Personalized Follow-up Program in the Type 2 Diabetes Prevention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04907760
• Other study ID #: 2021-A00375-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 10, 2021
• Est. completion date: October 10, 2026

Study information

• Verified date: September 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Aurelie LIETAER, MD
• Phone: 33 (0)5 59 57 75 60
• Email: a.lietaer[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: October 10, 2026
• Est. primary completion date: October 10, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Other:
• Personalized care program
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	5 years
Secondary	Diabetes diagnostic	measuring fasting blood glucose	at 5 years
Secondary	The Quality of Life	WHO questionary : total score out of 100, 26 questions with 5 likert scale items	at 5 years
Secondary	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.	during 5 years