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

NCT06050642 | Recruiting

• 2 other identifiers: PRO-DIAB-12023-A00891-44
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]

  Compare patient-reported levels of diabetes-related distress at 12 months. Higher T1-DDS-7 scores indicate higher levels of diabetes-related distress.

  Baseline visit (Month 0) to Final visit (Month 12)

Secondary Outcomes (28)

• A.1 Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]

  Baseline (Month 0) to Month 6

• 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]

  Baseline (Month 0) to Month 12

• A.3a Evolution of the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]

  quarterly between Baseline (Month 0) and Month 12

• A.3b Evolution of the 2-question Diabetes Distress Score (DDS2) [Comparison: Enhanced Care vs Standard Care]

  8 times between Baseline (Month 0) and Month 12

• B.1a Patient overall satisfaction with services provided by the home support provider

  monthly between Baseline (Month 0) and Month 12

Study Arms (2)

Control arm (Standard Care)

NO INTERVENTION

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

Interventional arm (Enhanced Care)

EXPERIMENTAL

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.

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

Interventions

enhanced care model provided by Timkl, a home support provider OTHER

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.

Interventional arm (Enhanced Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.)

Sponsors & Collaborators

• timkl: lead
• Sanoia: collaborator

Study Sites (1)

CHU Nice - Hôpital l'Archet 2

Nice, Paca, France

RECRUITING

Related Links

• study portal

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bruno GUERCI, MD PhD

  CHU NANCY

  PRINCIPAL INVESTIGATOR

• Gérard REACH, MD PhD

  Université Sorbonne Paris Nord

  STUDY CHAIR

Central Study Contacts

Antoine POUYET, MM

CONTACT

+33 4 76 52 67 49; antoine.pouyet@timkl.fr

Naima HAMAMOUCHE, M Sc A

CONTACT

+33 4 84 83 00 60; prodiab1@sanoia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: pragmatic, randomized, prospective, multisite (national), real-life study comparing home support service models

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 22, 2023
• Study Start: September 4, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)