NCT06050642 Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
| NCT ID | NCT06050642 |
| Status | Recruiting |
| Phase | — |
| Sponsor | timkl |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 340 participants in total. It began in 2023-09-04 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Bruno GUERCI, MD PhD
PRINCIPAL INVESTIGATOR
Central Hospital, Nancy, France
Frequently Asked Questions
Who can join the NCT06050642 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06050642 currently recruiting?
Yes, NCT06050642 is actively recruiting participants. Contact the research team at antoine.pouyet@timkl.fr for enrollment information.
Where is the NCT06050642 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT06050642 clinical trial?
NCT06050642 is sponsored by timkl. The principal investigator is Bruno GUERCI, MD PhD at Central Hospital, Nancy, France. The trial plans to enroll 340 participants.
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