NCT04907760: PROXIPART

Personalized Follow-up Program in the Type 2 Diabetes Prevention

Not yet recruiting NA Last updated 16 September 2021

What this trial tests

NA trial testing Personalized care program in Type2 Diabetes in 230 participants. Not yet recruiting.

Timeline

10 October 2021

Primary endpoint
10 October 2026

10 October 2026

Quick facts

Lead sponsor	GCS Ramsay Santé pour l'Enseignement et la Recherche
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	230
Start date	10 October 2021
Primary completion	10 October 2026
Estimated completion	10 October 2026

Drugs / interventions tested

• Personalized care program

Conditions studied

• Type2 Diabetes — all drugs for Type2 Diabetes →

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche — full company profile →

Who can join

Adults 18 to 75, any sex, with Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.