Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06050642

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

Led by timkl · Updated on 2025-07-18

340

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

T

timkl

Lead Sponsor

S

Sanoia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be an adult (age 218 years or older
  • Have Type 1 diabetes
  • Have been on closed-loop or insulin pump therapy for 6 months or longer
  • Have moderate or high diabetes-related distress defined as a DDS2 score of 6 or higher
  • Be able to understand and complete questionnaires in French
  • Be affiliated with the general French Social Security system
  • Have an e-mail address
  • Have a cell phone number
Not Eligible

You will not qualify if you...

  • Be deprived of liberty, under guardianship or curatorship
  • Not have Internet access or a cell phone
  • Already benefit or have benefited from the Enhanced Care program
  • Participating in an interventional study on a medical device for diabetes (pump, sensors, etc.)
  • Not regularly monitored at the investigating center or likely to change centers or move to a different living area within one year of inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Nice - Hôpital l'Archet 2

Nice, Paca, France

Actively Recruiting

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Research Team

A

Antoine POUYET, MM

CONTACT

N

Naima HAMAMOUCHE, M Sc A

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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