The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed
Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A
diverse population of patients with type 1 diabetes will be studied. The study population
will have a large range for duration of diabetes and glycemic control, as measured by
glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior
diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous
Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)
This is a 6 month, multi-center, randomized, parallel, adaptive study in type 1 diabetes with
a 6 month continuation period. The study will have three periods, per Cohort:
Run-in Period: The run-in period can be up to 60 days during which time a blinded CGM
sensor will be worn for two weeks.
Study Period: There will be a 6 month randomized study period with two arms: The HCL
system and Control.
Continuation Period: There will be a 6 month continuation period during which time all
subjects will use the HCL system with Auto Mode.
Up to 1500 subjects will be enrolled in order to have 1000 subjects complete the study. Up to
70 investigational Centers in the US, Europe, Canada, Australia and New Zealand will be
Insulin dependent diabetes mellitus,
Diabetes Mellitus, Type 1,
Diabetes Mellitus Types I and II,
type 1 diabetes mellitus,
type 1 diabetes,
diabetes type 1,
diabetes mellitus type 1,
type i diabetes mellitus
670G Insulin Pump,
Subject's Current Diabetes Therapy,
670G and 770G Insulin Pump
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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