Status:
RECRUITING
Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
Lead Sponsor:
timkl
Collaborating Sponsors:
Sanoia
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Amidst medical innovations, many Type 1 diabetes patients using advanced therapy show improved control but still suffer from diabetes-related distress. To tackle this, the investigators propose an "en...
Detailed Description
Amidst accelerating innovations in care and limited medical time, many patients with Type 1 diabetes treated by pump or closed-loop therapy appear to have improved glycaemic control, but still experie...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Be an adult (age ≥ 18 years)
- Have Type 1 diabetes
- Have been on closed-loop or insulin pump therapy for ≥ 6 months
- Be in moderate or high diabetes-related distress defined as a DDS2 score ≥ 6
- Be able to understand and complete questionnaires in French
- Be affiliated to the general French Social Security system
- Have an e-mail address
- Have a cell phone number
- Non-inclusion criteria:
- Be deprived of liberty, under guardianship or curatorship
- Not have Internet access or a cell phone
- Have benefited or are already benefiting from the Enhanced Care program
- Participating in an interventional study on a medical device for diabetes (pump, sensors, etc.)
- Patients who are not regularly monitored in the investigating center proposing to include them, or who are likely to change centers or move to a different living area (pharmacy) within a year of inclusion.
Exclusion
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06050642
Start Date
September 4 2023
End Date
October 1 2026
Last Update
July 18 2025
Active Locations (1)
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1
CHU Nice - Hôpital l'Archet 2
Nice, Paca, France