RECRUITINGINTERVENTIONAL

Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.

PRO-DIAB-1: Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.

About This Trial

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 "enhanced care" model involving healthcare providers and pharmacists. The study compares standard and enhanced care for Type 1 adults, focusing on the pharmacist's role. The main question it aims to answer is : In patients with type 1 diabetes treated with pump or closed-loop therapy, does the improved enhanced care versus conventional layout improve diabetes-related distress at 12 months? Participants will complete a monthly online questionnaire to assess their diabetes-related distress as well as their frequency of use of standard and enhanced care as well as the associated patient satisfaction.

Who May Be Eligible (Plain English)

Who May Qualify: - 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-Who May Qualify: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

enhanced care model provided by Timkl, a home support provider

A new type of care provided by timkl, a home support provider, involving nurses and the dispensing pharmacist. This approach combines the current tasks of the service provider's nurses with closer monitoring by the pharmacist, thanks to more frequent contacts and a holistic view of the patient.

Locations (1)

CHU Nice - Hôpital l'Archet 2

Nice, Paca, France