Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 Diab… (NCT05282264) | Clinical Trial Compass
CompletedNot Applicable
Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 Diabetes
France66 participantsStarted 2022-04-01
Plain-language summary
While closed-loop insulin delivery (CLID) systems demonstrated safety and effectiveness in patients with unbalanced type 1 diabetes (T1D), no studies have included patients with highly and chronically unbalanced diabetes.
The investigators conduct a retrospective, observational, and single-center study to evaluate the acceptability, safety, and efficacy of a CLID system in patients living with T1D (≥2 years) with a HbA1c\>11% in the past 12 months and a mean HbA1c \>10% over the past three years. Efficacy was assessed using continuous glucose monitoring parameters.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients with closed loop system :
* Adult patients
* With T1D for at least 2 years
* Follow-up in the diabetes department of the CHSF
* Having a laboratory HbA1c \> 11% at least once during the past year and at least one other HbA1c \> 10% in the previous 3 years
* Accepting the closed loop system as part of their support
* Subject informed of the study and not objecting to it
Patients without closed loop system :
Adult patients
* With T1D for at least 2 years
* Follow-up in the diabetes department of the CHSF
* Having a laboratory HbA1c \> 11% at least once during the past year and at least one other HbA1c \> 10% in the previous 3 years
* Refusing the closed loop system as part of their support or
* Patients for whom a multi-professional medical and paramedical collegial discussion (including diabetologist and nurse referents of the patient) within the service leads to the evaluation of an unfavorable benefit/risk ratio
* Subject informed of the study and not objecting to it
Exclusion Criteria:
Patients with closed loop system :
* Patients without an Internet connection, or without a smartphone or computer
* Patients for whom a multi-professional medical and paramedical collegial discussion (including diabetologist and patient referent nurse) within the department results in the assessment of an unfavorable benefit/risk ratio (patients with a history of interrupted pump treatment on medical decision, serious psychiatric disorders…)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.