Clinical Study Details
Development of Algorithms for a Prototype Closed Loop Insulin Pump (Closed Loop 1)
The purpose of the study is to understand the best way to stop an insulin pump from delivering insulin to prevent hypoglycemia. We think that if we take into account how quickly your blood sugar is dropping, we can stop the basal insulin from your pump for 1.5 hours and keep you from experiencing hypoglycemia. We hope that what we learn from this study can be used to set up communication between a continuous glucose monitor and an insulin pump.
You (or your child) are eligible for the study if you are between the ages of 3 and less than 46 years old. You must have a clinical diagnosis of type 1 diabetes within the past year and currently have been using an insulin pump for a minimum of 3 months. You are not eligible for the study if you have had a severe hypoglycemic (loss of consciousness or seizure) event in the past 18 months.
An enrollment visit will take approximately 2 hours. You will wear 2 Navigator Continuous Glucose Monitors for 1-3 days at home. You will then spend 8 hours at Stanford Medical Center in the research unit on two separate occasions. You will have the option of continuing to wear the Navigator at home for 13 weeks. You will use the Navigator in addition to your home glucose meter. You will be required to check your blood sugar 4 times per day. You must confirm Navigator blood sugar values with a fingerstick before making diabetes management changes. Also, you must check your blood sugar anytime the Navigator does not match how you are feeling. You will return to the Medical Center for appointments 1 week and 13 weeks following your hospital last stay. You will download the Navigator weekly and send the data to the Stanford Research Team.
If you are interested in the Closed Loop study, please contact Paula Clinton at (650) 736-2313 or by email at firstname.lastname@example.org to discuss any questions you may have and to schedule a screening appointment. The consent form is available below for your review.