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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Nice - Hôpital l'Archet 2
RECRUITING
Nice
Contact Information
Primary
Antoine POUYET, MM
antoine.pouyet@timkl.fr
+33 4 76 52 67 49
Backup
Naima HAMAMOUCHE, M Sc A
prodiab1@sanoia.com
+33 4 84 83 00 60
Time Frame
Start Date: 2023-09-04
Estimated Completion Date: 2026-10
Participants
Target number of participants: 340
Treatments
No_intervention: Control arm (Standard Care)
these patients will continue with their current home support provider's standard care
Experimental: Interventional arm (Enhanced Care)
these patients will be prescribed the enhanced care model to replace the standard care provided by their current home support provider. Patients are informed that they can return to standard care at the end of the study period (1 year), or at any time if they wish to leave the study.
Related Therapeutic Areas
Sponsors
Collaborators: Sanoia
Leads: timkl

This content was sourced from clinicaltrials.gov