T1D Insulin and Pramlintide Dual-Delivery Study at OHSU
OHSU is looking for adult participants to test how well a new closed loop system, called iPancreas, manages blood sugars in people with type 1 diabetes (T1D) using an Omnipod pump with insulin plus pramlintide.
Pramlintide is a synthetic (made in the lab) version of the hormone amylin, which helps regulate blood sugar in your body and is produced in the pancreas when you eat or drink. In people with T1D, the pancreas’ cells are destroyed by antibodies, preventing the body from producing amylin. Amylin slows down how quickly food leaves the stomach. This delays the entry of glucose into the bloodstream, which can help prevent blood sugar levels from rising too sharply after eating or drinking. Pramlintide is used with mealtime insulin to control blood sugar in people who have diabetes. Pramlintide is already FDA-approved for the management of T1D, when used with mealtime insulin.
As with any medical intervention, there are risks and benefits to participating in this study. Before you decide to participate, a member of the study team will explain all potential risks and benefits and answer any questions you may have.
INCLUSION CRITERIA
You may be eligible to participate if you are:
- Diagnosed with type 1 diabetes mellitus for at least 1 year
- Between ages of 18 to 70 years of age
- Currently using an insulin pump for at least 3 months OR current use of multiple daily injection insulin therapy with stable insulin settings for at least 2 weeks
- Using a carbohydrate ratio, at least occasionally, to dose meal-time insulin
- HbA1c ≤ 10.5% at screening
WHAT IS INVOLVED?
Your participation in the study will consist of 4 visits over approximately 6 weeks, as follows:
- 1.5 hour screening visit
- Short training on using the Dexcom G6 CGM with the study app
- 3 days of using pramlintide at home before the pramlintide treatment visit
- One 12.5 hour in-clinic visit to use both insulin and pramlintide
- One 12.5 hour in-clinic visit to use only insulin
Participants will be compensated up to $600 for their time.
HOW CAN I PARTICIPATE OR FIND OUT MORE?
To learn more about this study or find out if you’re eligible, please contact one of the following or scan the QR code:
Oregon Health and Science University | Portland, Oregon
Phone: 503-418-9070
Email: oregonapc@ohsu.edu