This trial is examining the effectiveness of a dual-hormone (insulin and glucagon) pump compared to insulin only pump and a predictive low glucose management (PLGM) system in patients with type 1 diabetes (T1D). The main outcome to be measured will be the percentage of time spent with a blood glucose less than 70mg/dl. This study is being conducted in Oregon, the United States.
The details
The only current treatment for T1D is insulin (the hormone that controls blood glucose). However, the main side effect of insulin is hypoglycemia (blood glucose going dangerously low). Therefore, new methods of delivery insulin are constantly being developed to reduce this risk.
Insulin can be delivered in a closed loop system. This is where the pump has a blood glucose sensor so it can adjust the amount of insulin delivered depending on blood glucose levels. Another pump system is the PLGM system which monitors blood glucose and stops insulin delivery when they reach a certain level. This prevents blood glucose from going too low.
Glucagon is a hormone that increases blood glucose levels. A dual hormone pump can deliver insulin to lower blood glucose but also delivers glucagon when blood glucose is getting too low.
The purpose of this study is to compare the effectiveness of a dual-hormone pump with an insulin only pump and a PLGM system. The main outcome to be measured will be the percentage of time spent with a blood sugar less than 70mg/dl.
Who are they looking for?
This study is recruiting 19 subjects with T1D using an insulin pump. Participants must be physically willing and able to do 45 minutes of exercise. They must live with someone who will be present when subject exercises at home and can attend the training for the hormone systems. Subjects must live within 40 miles of Oregon Health and Science University and need less than 139 units of insulin per day.
Female subjects must be willing to use adequate contraception during the study. Subjects must not uncontrolled heart disease, liver disease or seizure disorders. Subjects must not have an active infection or be taking any immunosuppressive drugs. Subjects must not have a bleeding disorder or a history of cancer in the past 5 years.
How will it work
Subjects will take part in three 76-hour studies. Each study will test a different one of the three insulin delivery systems: dual hormone pump, insulin only pump or PLGM system. The first 9 hours of each study will be spent in the treatment center and the rest of the time will be spent as an outpatient. Subjects will be given their meals at 8.30am and 12 noon and exercise of the treadmill for 45 minutes before being discharged home on day 1. The subject will return on day 4 to have the devices removed. Blood glucose levels will be monitored by the devices every 5 minutes and transmitted via bluetooth to a smartphone. This will happen automatically, subjects do not have to control the monitoring or the hormone delivery.
