RecruitingNot Applicable

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

France340 participantsStarted 2023-09-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]

Timeframe: Baseline visit (Month 0) to Final visit (Month 12)

Trial details

NCT IDNCT06050642

Sponsortimkl

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Antoine POUYET, MM

+33 4 76 52 67 49 antoine.pouyet@timkl.fr