Pramlintide Study

We are seeing volunteers to test a new closed loop system for managing your diabetes. A closed-loop insulin delivery system, also known as an artificial pancreas, is a medical device that treats type 1 diabetes by automatically delivering insulin based on sensor glucose levels. The system consists of an insulin pump and a continuous glucose monitor (CGM) sensor that communicate wirelessly to adjust insulin delivery. When blood sugar levels rise, the system increases insulin delivery, and when they fall, it reduces or stops delivery. The goal is to mimic how a pancreas would react to blood sugar changes, improving glucose control and improving the time your blood sugar is in the target range of 70-180 mg/dL.

The purpose of this study is to test how well a new investigational system, called iPancreas, manages your blood sugar with the ability to deliver insulin and a second drug, called pramlintide. iPancreas receives glucose values from the Dexcom G6 continuous glucose monitor (CGM). A CGM device is a small oval-shaped sensor that inserts a wire under the skin to measure glucose levels. A transmitter is placed over the sensor to transmit glucose values via Bluetooth every 5 minutes. iPancreas delivers insulin and pramlintide through Omnipod insulin pumps. An Omnipod is a small tube-less insulin pump that you wear on your body. The Omnipod inserts a small tube called a cannula under the skin to deliver insulin. The Omnipod transmits the insulin delivery data via Bluetooth.

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 type 1 diabetes, the pancreas' cells are destroyed by antibodies, preventing the body from producing amylin. This can lead to uncontrolled blood sugar levels. 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 a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. Pramlintide is already FDA-approved for the management of Type 1 Diabetes, when used with mealtime insulin.

You may be eligible to participate if you:

• Are diagnosed with type 1 diabetes for at least one year
• Are 18 to 70 years of age
• Have been using an insulin pump for at least 3 months OR current use of multiple daily injection insulin therapy with stable doses for greater than 2 weeks.
• Uses a carbohydrate ratio, at least occasionally, to dose meal-time insulin
• Have a HbA1c less than or equal to 10.5%

What is involved?

• 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 hours in-clinic visit to use both insulin and pramlintide
• One 12.5 hours in-clinic visit to use only insulin

Compensation is $600 for completion of all study visits. To learn more about this study or find out if you are eligible, please contact one of the following: Debbie Branigan at 503-418-9070 or oregonapc@ohsu.edu.

OHSU IRB 25279

DailyDose Smart Snack Study

We are seeking volunteers to test a new smart phone application. The purpose of this study is to learn more about a decision support tool that may be helpful in managing your diabetes. The study device, called DailyDose, will track your sensor glucose and make personalized snack recommendations at bedtime to prevent low blood sugar while you sleep. Participation in the study will consist of 6 clinic and 6 phone visits over approximately 12 weeks. Some visits can be virtual.

You may be eligible to participate if you:

• Are diagnosed with type 1 diabetes for at least one year
• Are age 18 years and older
• Are using multiple daily injection therapy
• Have an HbA1c <10% at time of screening
• Are currently using a glucose sensor with at least 2 episodes of overnight low glucose of less than 70 mg/dl for at least 10 minutes between 10pm and 6am in last 30 days

What is involved?

• 1.5 hour screening visit
• Complete 4 weeks using the Dexcom G6 CGM with app
• Complete 4 weeks using DailyDose app with Smart Snack recommendations
• Wear an Apple watch at night and complete a survey about sleep quality each week
• Weigh yourself weekly

Compensation is $400 for completion of all study visits. To learn more about this study or find out if you’re eligible, please contact one of the following: Debbie Branigan at 503-418-9070 or oregonapc@ohsu.edu.

Multi-site T1D Closed-Loop Study

Multi-site T1D Closed-Loop Study: Currently Seeking Adult Volunteers using t:slim X2 pump with Control IQ

This multi-site study is sponsored by OHSU with additional sites at University of Washington in Seattle. We are seeking volunteers to test a new closed loop system for patients who are currently using the t:slim X2 pump with Control IQ.  The purpose of this study is to test how well a new investigational closed loop system called iPancreas manages your blood sugar. The system uses a Dexcom G6 glucose sensor, the Omnipod insulin pump and a Polar M600 watch to determine rates of insulin to deliver. The system has the ability to detect when you forgot to enter your meal bolus insulin. You will complete two visits. For one visit, you will use our study device with Fiasp insulin starting with a 6 hour visit on campus followed by you using the system at home for 7 days. The other visit will require you to use your t:slim X2 pump with Control IQ with your own insulin for 7 days at home. Each site will enroll ~10 participants. Compensation is up to $600 for participating.

You may be eligible to participate if you are:

• Diagnosed with type 1 diabetes for at least one year
• Age 18 years and older
• Using the t:slim X2 pump with Control IQ active for at least 12 weeks
• HbA1c ≥ 7.5% at time of screening
• Live with another person age 18 or older who will sleep in the house at night

*You can find your GMI value within your Dexcom Clarity account under AGP

What is involved?

• 1.5 hour screening visit
• Two 7 day visits with one 6 hour in clinic visit
• Use the study device (Omnipod, Dexcom G6 and polar watch) with Fiasp insulin and your t:slim X2 pump with Control IQ enabled with your own insulin
• To learn more about this study or find out if you’re eligible, please contact one of the following:

Oregon Health and Science University | Portland, Oregon

Phone: 503-418-9070                                                                      

Email: oregonapc@ohsu.edu

University of Washington | Seattle, Washington

Email: rambre@medicine.washington.edu

Advarra IRB# Pro00067326

OHSU IRB# 24218

HSDHC Homepage:

www.ohsu.edu/diabetes