Home support for adults with type 1 diabetes using insulin pumps
Tests enhanced home care with pharmacist help in adults with type 1 diabetes.
Key facts
- Who runs it
- timkl
- Where
- Nice, FranceSee the site
- Trial code
- Registry title
- Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
- Status
- Recruiting
- People taking part
- 340 people, planned
- Started
- 4 Sept 2023
- Planned end
- Oct 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- enhanced care model provided by Timkl, a home support provider
- Record updated
- 18 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes who use an insulin pump or closed-loop system and have moderate or high diabetes-related distress. It compares standard care with enhanced care that involves pharmacists.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Type 1 diabetes with moderate or high diabetes-related distress (DDS2 score of 6 or more)
- Earlier treatment
- Must have used closed-loop or insulin pump therapy for 6 months or more. Must not have had or be getting the Enhanced Care program.
Main reasons for not taking part
- Deprived of liberty, under guardianship or curatorship
- No internet access or no cell phone
- Already had or already getting the Enhanced Care program
- Taking part in a study of a medical device for diabetes (pump, sensors, etc.)
- Not regularly followed at the investigating center, or likely to change centers or move to a different living area within a year
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Where in France
- CHU Nice - Hôpital l'Archet 2Nice, FranceContact: Nicolas CHEVALIERTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Control arm (Standard Care)No study treatment, for comparison
these patients will continue with their current home support provider's standard care
- Interventional arm (Enhanced Care)Treatment being tested
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: enhanced care model provided by Timkl, a home support provider
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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.
- Plain-language title
- Home support for adults with type 1 diabetes using insulin pumpsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 July 2025