Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04907760 |
| Other study ID # |
2021-A00375-36 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
