Status:
COMPLETED
Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 Diabetes
Lead Sponsor:
Centre Hospitalier Sud Francilien
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
If hybrid closed-loop systems (HCLS) ("artificial pancreas") for automated insulin administration have demonstrated their great interest in patients living with moderately unbalanced type 1 diabetes (...
Eligibility Criteria
Inclusion
- 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
- 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…)
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05282264
Start Date
April 1 2022
End Date
December 11 2023
Last Update
December 21 2023
Active Locations (2)
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1
Penfornis
Corbeil-Essonnes, Centre Hospitalier Sud Francilien, France, 91106
2
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106