Full Day and Night Closed-Loop With DiAs Platform
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The overall aim of this proposed research is to determine the safety, feasibility and
      efficacy of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in
      children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting.
      This will be addressed in two parts: 1) An in residence, outpatient study to determine safety
      and feasibility of the DiAs during 72 continuous hours of day and night glucose control; and
      2) Camp studies planned for the summer of 2014 with randomization to either full closed-loop
      or sensor-augmented pump therapy over the duration of 6-7 day diabetes camps.
    

Detailed description: 
      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.
    

Intervention name(s): Diabetes Assistant (DiAs) with USS Virginia; Sensor Augmented Pump Therapy
Intervention type(s): Device; Other
Intervention description(s): 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.; 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 intervention name(s): Closed-Loop system; SAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Artificial Pancreas Project (APP); Diabetes Assistant (DiAs); Closed-Loop Control (CLC); Continuous Glucose Monitor (CGM); Insulin Pump