Sansum Diabetes Research Institute | Santa Barbara, CA
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About
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)
Full description
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:
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 enrolled.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria
Subject is age 2-80 years at time of screening
Subjects who are 2-21 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day
Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study
Subject has been diagnosed with type 1 diabetes for at least three months Note: Determination of classification for diabetes will be based on American Diabetes Association Clinical Practice Guidelines accounting for several patient characteristics such as: age of onset, patient's weight or BMI, history of diabetic ketoacidosis, history of therapy management, if available in the medical records.
Subject must be on one of the following management therapies:
Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
Subject is willing to perform required study procedures
Subject is willing to wear the system continuously throughout the study for at least 80% of the time.
Subject is willing to upload data at least weekly from the study pump/meter, must have Internet access and a computer system that meets the requirements for uploading the study pump/meter for data collection
Subject must be willing to use the study glucose meter system (i.e. along with study meter strips).
If subject has celiac disease, it has been adequately treated as determined by the investigator
Subject with the diagnosis of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease, within 1 year of screening, will be included in the study with the consent of the Investigator
Subject is willing to take one of the following insulins and can financially afford to use either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
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280 participants in 2 patient groups
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Central trial contact
Thomas Troub; Briggitte Marinos
Data sourced from clinicaltrials.gov
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