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This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase.
Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6.
Then, a 3-month study phase will be performed during 12 weeks:
An extension period of 6 months with the Closed-loop System (closed-loop condition) will be performed at the end of the study phase for all patients enrolled.
Enrollment
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Volunteers
Inclusion criteria
age 14 - 75 years at time of screening
Type 1 diabetes
Subject has a clinical diagnosis of type 1 diabetes for at least 2 years as determined via medical records or source documentation by an individual qualified to make a medical diagnosis.
An insulin pump user for at least 6 months (with or without CGM experience),
Living in an area covered by a GSM (Global System for Mobile Communications) network
Patient not isolated, does not live alone, or has a person living nearby who has a telephone and a key to his or her home
Patient willing to wear the system continuously throughout the study
Has TSH in the normal range
if subject has celiac disease, it has been adequately treated as determined by the investigator
With history of cardiovascular event 1 year or more from the time of screening must have an EKG within 6 months prior to screening and a stress test within 6 months prior to screening or during screening. If subject has an abnormal stress test, he will not be allowed to participate in the study, unless there is clearance from a cardiologist. If subject fails stress test, participation is allowed only if there is clearance from a cardiologist
With 3 or more cardiovascular risk factors listed below must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist. Cardiovascular risk factors include:
Must be able to speak and be literate in French
For adults (18 - 75 years old): having provided written informed consent
For adolescents (14 - 17 years old): having provided written assent & parents/guardian having provided written informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
184 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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