USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
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|ClinicalTrials.gov Identifier: NCT02302963|
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: AP System (DiAs or inControl) with USS Virginia Device: Sensor-Augmented Pump Therapy (placebo)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Unified Safety System (USS) Virginia Closed-Loop Versus Sensor Augmented Pump Therapy for Hypoglycemia Reduction in Type 1 Diabetes|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: AP System (DiAs or inControl) with USS Virginia
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then proceed through 7 weeks of training and use of the AP System with USS Virginia and study pump. The inpatient testing will be repeated after wearing the AP System at home.
Device: AP System (DiAs or inControl) with USS Virginia
Subject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.
Placebo Comparator: Sensor-Augmented Pump Therapy
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then wear a continuous glucose monitor and their own insulin pump at home for 5 weeks. The inpatient testing will be repeated at the completion of the 5 weeks at home.
Device: Sensor-Augmented Pump Therapy (placebo)
Subject will participate in 5 weeks use of CGM and personal insulin pump at home.
- Reduction in hypoglycemia during closed loop control (assessed by Low Blood Glucose Index [LBGI]) [ Time Frame: 1 week ]Reduction in hypoglycemia during the study on USS Virginia versus Sensor Augmented Pump (SAP) as assessed by Low Blood Glucose Index (LBGI) from Continuous Glucose Monitoring (CGM) during 1 week of baseline blinded use versus during the last week of intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302963
|United States, California|
|Stanford, California, United States, 94305|
|United States, Virginia|
|University of Virginia Center for Diabetes Technology|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Stacey M. Anderson, MD||UVA Center for Diabetes Technology|
|Principal Investigator:||Bruce Buckingham, MD||Stanford University|