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NCT Number: NCT04907760

Personalized Follow-up Program in the Type 2 Diabetes Prevention

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized care program

Other

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 outcomes

  1. Risk factors for type 2 diabetes in participants

    Time frame: 5 years

    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 outcomes

  1. Diabetes diagnostic

    Time frame: at 5 years

    measuring fasting blood glucose

  2. The Quality of Life

    Time frame: at 5 years

    WHO questionary : total score out of 100, 26 questions with 5 likert scale items

  3. program compliance

    Time frame: during 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurelie LIETAER, MD

CONTACT

[email protected]

33 (0)5 59 57 75 60

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: PROXIPART

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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