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

timkl

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: enhanced care model provided by Timkl, a home support provider

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06050642

2023-A00891-44 (Other Identifier)

PRO-DIAB-1

Details and patient eligibility

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.

Full description

Amidst accelerating innovations in care and limited medical time, many patients with Type 1 diabetes treated by pump or closed-loop therapy appear to have improved glycaemic control, but still experience significant diabetes-related distress.

The investigators therefore propose that a new form of patient care service provided by a health service provider and the patient's pharmacist, as part of the new type of care called "enhanced care", could contribute to overcoming this challenge.

This study compares two different care services provided to adult patients with Type 1 diabetes (PwT1D) treated with an insulin pump or a closed-loop system, known as standard care and enhanced care, the main difference between which lies in the pharmacist's involvement in the enhanced care model.

The originality of this project lies in several points:

• Firstly, it involves evaluating a new care model called enhanced care, which has the original feature of including the involvement of the patient's dispensing pharmacist.
• The role of home support providers in the psychological aspects of diabetes is poorly documented in the scientific literature.

Diabetes-related distress is a well-known complication, but means of prevention remain inadequate. This study integrates live collection of patient data, by the patient. Patient experience is an innovative approach that plays an increasingly important role in the evaluation of new management approaches.

• In addition to patient data, this study integrates data from pharmacists and physicians. These data will be used to compare the points of view of healthcare professionals and patients, in order to gain a precise idea of the service provided by the enhanced care. In itself, this comparison could contribute to identifying and understanding the difference in the points of view of healthcare professionals and patients.
• While there is a wealth of literature demonstrating the value of pharmacist involvement in the care of Type 2 diabetic patients, such information is lacking for Type 1 diabetes. This study, aimed at investigating the impact of the pharmacist, specifically on the distress of patients undergoing highly technical treatment, is therefore original.
• Finally, the design of this pragmatic, randomized study enables real-life practices to be analyzed, while maintaining the highest possible level of evidence.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

340 participants in 2 patient groups

Control arm (Standard Care)

No Intervention group

Description:

these patients will continue with their current home support provider's standard care

Interventional arm (Enhanced Care)

Experimental group

Description:

these patients will be prescribed the enhanced care model to replace the standard care provided by their current home support provider. Patients are informed that they can return to standard care at the end of the study period (1 year), or at any time if they wish to leave the study.

Treatment:

Other: enhanced care model provided by Timkl, a home support provider