NCT05282264Completed
Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 66 (actual)
- First submitted
- 4 Feb 2022
- Start date
- 1 Apr 2022
- Primary completion date
- 15 Jul 2023
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Diseases
- Type 1 diabetes
- NCT number
- NCT05282264
What you commit to
- Study type: Observational
- Participants enrolled: 66
- From 1 Apr 2022 to the primary completion date, 15 Jul 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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…)
Other
- Patients with closed loop system :
- Patients without an Internet connection, or without a smartphone or computer
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Penfornis Coordinator of this site? Confirm its status | Corbeil-Essonnes | France | Unknown status |
| Centre Hospitalier Sud Francilien Coordinator of this site? Confirm its status | Corbeil-Essonnes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.