NCT06050642Recruiting
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.
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 1 Sept 2023
- Start date
- 4 Sept 2023
- Primary completion date
- Oct 2026
- Lead sponsor
- timkl
- Diseases
- Type 1 diabetes
- NCT number
- NCT06050642
What you commit to
- Study type: Interventional
- Planned participants: 340
- From 4 Sept 2023 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Nice - Hôpital l'Archet 2 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.