Clinical trial NCT04907760: Personalized Follow-up Program in the Type 2 Diabetes Prevention
Official title: Personalized Follow-up Program in the Type 2 Diabetes Prevention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type2 Diabetes
Keywords: Diabetes
Metabolic Diseases
Endocrine System Diseases
Prevention
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, prospective, randomized, controlled, two arms, multicentric study
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Risk factors for type 2 diabetes in participants
timeFrame: 5 years
Secondary outcomes:
measure: Diabetes diagnostic
timeFrame: at 5 years
measure: The Quality of Life
timeFrame: at 5 years
measure: program compliance
timeFrame: during 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Clinique Aguilera-RGDS
name: Aurelie LIETAER, MD
role: PRINCIPAL_INVESTIGATOR
References: