Full Day and Night Closed-Loop With DiAs Platform
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|ClinicalTrials.gov Identifier: NCT02147860|
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : July 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Diabetes Assistant (DiAs) with USS Virginia Other: Sensor Augmented Pump Therapy||Not Applicable|
This study is an early feasibility study that will test the efficacy of DiAs - a smart-phone-based system compared to sensor augmented therapy in an outpatient setting. Twelve study subjects with type 1 diabetes, six each at UVa and Stanford University, who have experience with insulin pump use at two clinical sites will be recruited. The first six subjects recruited will be aged 15-18 years and this will follow with recruitment of six subjects aged 10-14 years. This study is designed to mimic the protocol at camp and will include a period of light exercise after breakfast and moderate intensity physical activity after lunch, with group activities such as soccer and volleyball. The duration of the Outpatient in Residence Study will be 72 hours. The data will be reviewed by the Data Safety Monitoring Board (DSMB) before proceeding to camp studies.
The camp study will recruit 48 subjects, with type 1 diabetes who have experience with insulin pump therapy. Initial studies will be conducted at a camp with older participants aged 15-35 years, with at least 5 of the campers between 15-18 years old. These studies will be reviewed by the DSMB and, if safe, we will recruit additional children aged 10-14 years of age. The duration of the Diabetes Camp Studies will be up to 7 days/6 nights.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Full Day and Night Closed-Loop With DiAs Platform|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Placebo Comparator: Sensor Augmented Pump Therapy
Each camp participant will be randomized to full day and night CLC or sensor augmented pump therapy for up to 7 days/6 nights. The subject will wear a continuous glucose monitoring system (CGM) to measure sensor glucose and a physiological monitor to measure heart rate and 3-axis accelerometer for 24-72 hours.
Other: Sensor Augmented Pump Therapy
Subjects randomized to this placebo group will wear a continuous glucose monitoring system (CGM) to measure sensor glucose and a physiological monitor to measure heart rate and 3-axis accelerometer for 24-72 hours.
Other Name: SAP
Experimental: Diabetes Assistant (DiAs) with USS Virginia
With the use of the UVA Artificial Pancreas (DiAs), the study will assess safety and feasibility and are not powered for statistical significance. These studies are intended to train staff on system function and obtain data regarding safe and feasible system use.
Camp participants will be randomized to either closed-loop control using the DiAs or sensor-augmented pump therapy only. These studies would generate up to 120 days of closed-loop data and 120 comparable days of open-loop data.
Device: Diabetes Assistant (DiAs) with USS Virginia
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.
Other Name: Closed-Loop system
- DiAs time within target [ Time Frame: 7 days/6 nights ]Determine the efficacy of glucose control, as determined by the percentage of sensor glucose readings in the target range
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): NCT02147860
|United States, California|
|Stanford, California, United States, 93405|
|United States, Virginia|
|University of Virginia Center for Diabetes Technology|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Bruce Buckingham, MD||Stanford University|