USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02131766|
Recruitment Status : Completed
First Posted : May 6, 2014
Results First Posted : April 16, 2020
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Device: DiAs Other: Sensor Augmented Pump Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Unified Safety System (USS) Virginia Closed-Loop Versus Sensor Augmented Pump Therapy for Overnight Control in Type 1 Diabetes|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: USS Virginia Closed Loop Control
The subject will be admitted to the research house/hotel and will be discharged after 5 nights. The subject will be trained on DiAs and on how to respond to the system's alerts. The DiAs will be initiated by 11:00 PM and will be discontinued before breakfast. The staff will be monitoring the subject remotely. The subject will need to remain within a 30 miles of the research house/hotel during the day and return by 6:00 PM.
A limited number of UVA and UPadova subjects will be asked to wear the DiAs at home for 5 days at the conclusion of research house admission.
DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and help avoid hypoglycemia during the night.
Placebo Comparator: Sensor Augmented Pump Therapy
The subject will wear the continuous glucose monitor with the study insulin pump for a full 7 day period (approximately 7 consecutive 24 hour periods). The subject will follow their usual regimen. The subject will be asked to use the bolus calculator function on your insulin pump and enter the carbohydrate information that you eat during the week.
Other: Sensor Augmented Pump Therapy
Insulin pump plus CGM.
Other Name: SAP
- USS Virginia Time Within Target [ Time Frame: 40 hours ]Assess the effect size of USS Virginia in increasing time within target (70-180 mg/dL) over a 24-hour period with closed-loop control overnight (23:00 to 07:00) as compared to sensor-augmented pump alone.
- Overnight Target Range [ Time Frame: 40 hours ]Assess time spent within target range of 80-140 mg/dl overnight with USS Virginia Closed Loop compared to sensor-augmented pump therapy alone
- Decreased Overnight Hypoglycemia [ Time Frame: 40 hours ]Assess the effect of USS Virginia Closed Loop System to decrease hypoglycemia overnight compared to sensor-augmented pump therapy alone
- Morning Glucose Levels [ Time Frame: 40 hours ]Assess the distribution of wake-up glucose levels at 07:00 achieved by USS Virginia Closed Loop vs. to sensor-augmented pump therapy alone;
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): NCT02131766
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Mount Sinai Hospital|
|New York, New York, United States, 10029-6574|
|United States, Virginia|
|University of Virginia Center for Diabetes Technology|
|Charlottesville, Virginia, United States, 22903|
|University of Padova|
|Padova, Italy, 35131|
|Principal Investigator:||Sue Brown, MD||University of Virginia|
|Principal Investigator:||Carol Levy, MD, CDE||MOUNT SINAI HOSPITAL|
|Principal Investigator:||Yogish C. Kudva, MBBS, MD||Mayo Clinic|
|Principal Investigator:||Claudio Cobelli, PhD||University of Padova|