Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRamsay Générale de Santé

About this trial

In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated,since it does not take into account people who are untreated or not diagnosed. However,it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis.

The Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life.

From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros.

This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient, male or female, over the age of 18

Patient with a FINDRISC score ≥10 points

Beneficiary of a French health insurance system

Patient having been informed and having given their consent free, enlightened and written

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Study nurse intervention

    Behavioral

    Contact everay 4 months with a dedicated study nurse

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: TD2 standardActive comparator 1 intervention
Group B: TD2+ study NurseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

FINDRISC score

FINDRISC is a prediction tool to identify patients at risk of developing diabetes without biological analysis.

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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Ramsay Générale de Santé

Lead sponsor

European Clinical Trial Experts Network

Collaborator