Clinical trial NCT06050642: Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
Official title: PRO-DIAB-1: Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 diabetes
diabetes distress
insulin pump
insuline closed-loop
home support provider
quality of life
disease burden
treatment satisfaction
Time in Range
Patient-Physician interactions
Pharmacist
Lead sponsor: timkl
Sponsor class: INDUSTRY
Collaborators: name: Sanoia
First posted: 2023-09-22
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic, randomized, prospective, multisite (national), real-life study comparing home support service models
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

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.

Primary outcomes:
measure: Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
timeFrame: Baseline visit (Month 0) to Final visit (Month 12)
Secondary outcomes:
measure: A.1 Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
timeFrame: Baseline (Month 0) to Month 6
measure: A.2 Change in the sub-scores of the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
timeFrame: Baseline (Month 0) to Month 12
measure: A.3a Evolution of the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
timeFrame: quarterly between Baseline (Month 0) and Month 12
measure: A.3b Evolution of the 2-question Diabetes Distress Score (DDS2) [Comparison: Enhanced Care vs Standard Care]
timeFrame: 8 times between Baseline (Month 0) and Month 12
measure: B.1a Patient overall satisfaction with services provided by the home support provider
timeFrame: monthly between Baseline (Month 0) and Month 12
measure: B.1b Frequency of patients' interactions with the home support provider
timeFrame: monthly between Baseline (Month 0) and Month 12
measure: B.1c Satisfaction with specific aspects of the services provided by the home support provider
timeFrame: monthly between Baseline (Month 0) and Month 12
measure: B.2a (Intervention group only) Number of pharmacy visits
timeFrame: monthly between Baseline (Month 0) and Month 12
measure: B.2b (Intervention group only) Duration of pharmacy visits
timeFrame: monthly between Baseline (Month 0) and Month 12
measure: B.2c (Intervention group only) Description of clinical or non-clinical events impacting diabetes
timeFrame: monthly between Baseline (Month 0) and Month 12
measure: B.3a Patients' Perceived Effectiveness of Patient-Physician Interactions (PEPPI questionnaire)
timeFrame: at Month 6 and at Month 12
measure: B.3b Patient Assessment of Chronic Illness Care (PACIC questionnaire)
timeFrame: at Baseline (Month 0) and at Month 12
measure: B.3c Patient assessment of information flow and transparency
timeFrame: at Month 6 and at Month 12
measure: B.3d Patient assessment of how representatives of the home support provider treat confidential information
timeFrame: at Month 6 and at Month 12
measure: B.4a Specialist Physician satisfaction with the services provided by the home support provider to their patients
timeFrame: Month 12
measure: B.4b Specialist Physician satisfaction with quantity and pertinence information provided by the home support provider on their patients
timeFrame: Month 12
measure: B.5a (intervention group) Pharmacist satisfaction with the services provided by the home support provider to their patients
timeFrame: Month 12
measure: B.5b (intervention group) Pharmacist satisfaction with the length of interactions with patients
timeFrame: Month 12
measure: B.5c (intervention group) Pharmacist satisfaction with the number of interactions with patients
timeFrame: Month 12
measure: B.5d (intervention group) Pharmacist perception of the usefulness of their increased role in diabetes management
timeFrame: Month 12
measure: C.1 Self-reported ability to use their insulin delivery system(pump or closed loop) [Comparison: Enhanced Care vs Standard Care]
timeFrame: monthly from Baseline (Month 0) to Month 12
measure: Physician assessment of patient's ability to use their insulin delivery system (pump or closed loop [Comparison: Enhanced Care vs Standard Care]
timeFrame: Month 12
measure: C.3a Patient satisfaction with treatment as measured by the Diabetes Treatment Satisfaction Questionnaire - status (DTSQs) [Comparison: Enhanced Care vs Standard Care]
timeFrame: Baseline (Month 0) and at Month 12
measure: C.3b Patient perception of treatment burden [Comparison: Enhanced Care vs Standard Care]
timeFrame: Baseline (Month 0) and at Month 12
measure: D.1 Time in the glycemic target range [Comparison: Enhanced Care vs Standard Care]
timeFrame: Month 12
measure: Percentage of glycated hemoglobin (HbA1c) [Comparison: Enhanced Care vs Standard Care]
timeFrame: at Baseline (Month 0) and at Month 12
measure: E.1 Patient quality of life [Comparison: Enhanced Care vs Standard Care]
timeFrame: at Baseline (Month 0) and at Month 12
measure: E.2 Number and relevance of impact that can have an impact on diabetes [Comparison: Enhanced Care vs Standard Care]
timeFrame: monthly between Baseline (Month 0) and Month 12
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Nice - Hôpital l'Archet 2
state: Paca
Study officials:
affiliation: CHU NANCY
name: Bruno GUERCI, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Sorbonne Paris Nord
name: Gérard REACH, MD PhD
role: STUDY_CHAIR
References: