Actively Recruiting
Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes
Led by Ramsay Générale de Santé · Updated on 2022-04-13
230
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Ramsay Générale de Santé
Lead Sponsor
E
European Clinical Trial Experts Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying type 2 diabetes (T2DM), a common form of diabetes affecting many adults in France, often going undiagnosed for years due to its silent nature. This study aims to explore a different, more coordinated approach focused on prevention rather than treatment, given that lifestyle factors like diet and inactivity are major risks. The study addresses the high health and economic burden of diabetes, which affects millions and results in significant healthcare costs. The study compares standard care for type 2 diabetes with an additional personalized follow-up involving a dedicated study nurse who contacts participants every four months. Participants are randomized to either continue standard diabetes follow-up or receive this extra nurse support alongside their usual care. This behavioral intervention is designed to enhance prevention efforts through more frequent and personalized engagement. Participants will be involved in regular follow-ups for up to five years, during which their risk of developing diabetes is assessed using the FINDRISC score. The study will monitor participants' health and lifestyle factors over time to evaluate the impact of the nurse-led intervention. Researchers will collect data on diabetes risk and study compliance while ensuring participant safety and confidentiality throughout the study duration.
CONDITIONS
Brief Title
Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient, male or female, over the age of 18
- Patient with a FINDRISC score 210 points
- Beneficiary of a French health insurance system
- Patient having been informed and having given their consent free, enlightened and written
You will not qualify if you...
- Patient over 75 years old
- Patient already diagnosed with type 2 diabetes
- Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant
- Patient participating in another research
- Patient in period of exclusion from another research always in progress at the time of inclusion
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration
- Pregnant, breastfeeding or parturient women
- Patient hospitalized without consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive standard type 2 diabetes prevention follow-up. Those in the experimental group have additional contact every 4 months with a dedicated study nurse.
Visits every 4 months for participants in the study nurse follow-up group; standard follow-up visits for others
Trial Site Locations
Total: 1 location
1
Clinique Aguiléra
Biarritz, Aquitaine, France, 64200
Actively Recruiting
Research Team
J
JF OUDET
M
MH BArba
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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