Impact of Enhanced Care for Adults with Type 1 Diabetes Using Insulin Pumps
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.
Run by timkl · NCT06050642 · Data updated 2026-11-12
This study is testing whether getting extra support from pharmacists helps adults with Type 1 diabetes using insulin pumps feel less stressed about their condition over a year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 340 (estimated) |
| Sponsor | timkl Industry-sponsored |
| Locations | 1 site (Nice, Paca) |
| Status | Recruiting |
| Started | September 4, 2023 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | July 18, 2025 |
| Trial ID | NCT06050642 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with Type 1 diabetes who have been on insulin pump or closed-loop therapy for at least six months and are experiencing moderate to high diabetes-related distress.
✕Probably not a fit
Patients who are not experiencing diabetes-related distress or those already enrolled in the Enhanced Care program may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of an enhanced care model that includes the involvement of pharmacists for adults with Type 1 diabetes who are using insulin pumps or closed-loop therapy. Participants will be divided into two groups: one receiving standard care and the other receiving enhanced care, with a focus on reducing diabetes-related distress over 12 months. Monthly online questionnaires will be used to assess the level of distress and patient satisfaction with the care received. The study aims to provide insights into the role of pharmacists in managing diabetes-related psychological challenges.
Why it matters
Potential benefit: If successful, this approach could significantly reduce diabetes-related distress in patients, improving their overall quality of life.
How similar studies have gone: While the concept of enhanced care is innovative, similar studies focusing on integrated care models have shown promise in improving patient outcomes.
Who can join: the full rules
Show full inclusion / 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.
Where it's running
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CHU Nice - Hôpital l'Archet 2
Nice, Paca, France Recruiting
Study contacts
- Principal investigator: Bruno GUERCI, MD PhD — Central Hospital, Nancy, France
- Study coordinator: Antoine POUYET, MM
- Email: antoine.pouyet@timkl.fr
- Phone: +33 4 76 52 67 49
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.