RecruitingNot ApplicableNCT06050642

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.

Sponsor

timkl

Enrollment

340 participants

Start Date

Sep 4, 2023

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

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

Min Age: 18 Years

Inclusion Criteria13

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
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.

Interventions

OTHERenhanced 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.