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Clinical Trials in France / NCT06050642
Recruiting Not applicable

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

NCT06050642 · tracked via the Priya Life Science France tracker
Sponsor
timkl
Phase
Not applicable
Started
2023-09-04
Last updated
2025-07-18

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

enhanced care model provided by Timkl, a home support provider

enhanced 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care] — Baseline visit (Month 0) to Final visit (Month 12)
    Compare patient-reported levels of diabetes-related distress at 12 months. Higher T1-DDS-7 scores indicate higher levels of diabetes-related distress.

Trial sites (1)

FacilityCityRegionStatus
CHU Nice - Hôpital l'Archet 2 Nice Paca Recruiting

Other trials for the same condition

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE) Recruiting
Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) Active, not recruiting
Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes Starting soon
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France Recruiting
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06050642 on ClinicalTrials.gov ↗ ← All trials in France