Informations générales (source: ClinicalTrials.gov)
PRO-DIAB-1: Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
Interventional
N/A
timkl (Voir sur ClinicalTrials)
septembre 2023
octobre 2026
16 septembre 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Nice - Hôpital l'Archet 2 - Nice - Paca - France | Nicolas CHEVALIER | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.