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Home support for adults with type 1 diabetes using insulin pumps

Tests enhanced home care with pharmacist help in adults with type 1 diabetes.

Plain-language title generated from the registry record
Registry title: Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.

Key facts

Where
Nice, FranceSee the site

Where in France

  • CHU Nice - Hôpital l'Archet 2Nice, FranceTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
timkl
Trial code
NCT06050642
Record updated
18 July 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

ClinicalTrials.gov NCT06050642