Nocturnal Closed-Loop Control Using An ePID (Enhanced Proportional Integral Derivative) Algorithm On An Android Platform With Remote Monitoring In A Closely Monitored Camp Setting: The OCL Camp Study

The steps are the same for the inpatient and camp studies, except that during the inpatient study subjects will have an IV inserted and blood samples will be obtained every 1/2 hour overnight. They will also have 20-30 minutes of activity in the afternoon and evening. After 16 subjects have entered the inpatient study, their data will be sent to the DSMB (Data Safety Monitoring Board) for review. If the studies show that these studies have met our predefined safety criteria, and the DSMB approves, we will then conduct our outpatient studies.

Step 1:

Subjects who are eligible for the study (camp or inpatient hospital) will be contacted by phone and email, the study will be explained to them, and after written consent is obtained, they will be enrolled in the study. They will be mailed a Bayer Next meter, control solutions, and glucose test strips.

Step 2: The will perform quality control test on the meter using the control solutions, and email these results to the study coordinator. For the week prior to the research center admission or camp they will be asked to use the Bayer meter to obtain two fasting glucose levels 20 minutes apart. They will be called by the study coordinator 3-5 days prior to admission to review these blood glucose testing requirements with the family. Subjects who have at least 3 days of data will be eligible for study participation.

Step 3: On arrival to the hospital, camp or bus stop subjects will bring an original informed consent signed by both parents and/or guardians if less than 18 years old. This generally occurs between 10 AM and noon at the camps, and we will have them arrive before lunch to the research center.