Context Aware Closed loop Study

We are seeking volunteers to test a new closed loop system for type 1 diabetic patients who are currently using an FDA-approved hybrid closed-loop system. The purpose of this study is to test how well a new investigational system, called iPancreas, manages your blood sugar with the ability to detect patterns from data collected by study devices. These patterns will be used by iPancreas to see which patterns cause high blood sugar levels then recommend correction insulin.

Your participation in the study will consist of 4 visits over approximately 16 weeks. You will be asked to use iPancreas and study devices at home for 4 weeks. You will be asked to complete meal and exercise challenges. You will receive $700 for completion of all study visits. You will be paid an additional $25 for each exercise and meal challenge you complete up to $450.

You may be eligible to participate if you are:

• Diagnosed with type 1 diabetes for at least one year
• Age 18 or older
• Current use of an FDA-approved hybrid closed loop system for ≥3 months
• A1c or GMI ≥ 7.0%  Live within 40 miles of OHSU
• Total daily insulin requirement is less than 139 units/day

What is involved?

• 1.5 hour screening visit
• A training visit on iPancreas and study devices
• Two virtual visits, one at 3 weeks and one at 4 weeks

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 26005

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

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

FINE-ONE Study

The OHSU Harold Schnitzer Diabetes Center (PI: Dr. Rodica Busui, MD PhD) is one of the few academic institutions that are part of a new study (FINE-ONE). Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes.

In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. Finerenone is approved for doctors to prescribe to people with chronic kidney disease and type 2 diabetes.

This study is seeking volunteers who are over 18 years of age, have Type 1 diabetes continuously treated with insulin, and have been told by their doctor they have CKD or increased protein levels in their urine.

Key Eligibility Criteria:

• Are 18 years or older
• Have type 1 diabetes, continuously treated with insulin
• Have a HbA1c at screening less than 10%
• Have a clinical diagnosis of chronic kidney disease (or have been told by your doctor you have increased protein levels in your urine)

Duration: The participants will be in the study for up to 7.5 months. Participants will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times.

If you are interested or would like more information, please contact the study coordinator Ariel Miyama at 503-830-9571 or email miyama@ohsu.edu.

OHSU IRB# 27117

Would you be interested in trying a new GLP-1 medication similar to Ozempic?

We are seeking volunteers to test a new investigational glucagon-like peptide-1 (GLP-1) medication similar to Mounjaro and Ozempic. However, this GLP-1 will be approved for Type 1 instead of Type 2 diabetics and unlike other GLP-1 medications on the market, the study drug has not been shown to cause skeletal muscle loss. The purpose of this study is to see how safe and tolerable the study drug is and to see if the study drug improves your diabetes management. This category of drugs helps regulate blood sugar, appetite and digestion. If you agree to be in the study, you may be given the study drug or a placebo (a placebo does not contain any active ingredients but looks like the study drug). Your participation in this research study will involve approximately 13 visits to the research center and will last about 25 weeks.

Compensation is $100 for each visit and potential to receive stipends totally $250.

You may be eligible to participate if you are:

• Diagnosed with type 1 diabetes for at least one year
• Age 18 to 65 years old
• Stable insulin dosing/formulation for at least 2 months
• HbA1c between 7-10%
• BMI 27 or higher
• Have not used nicotine products during the last 6 months
• Have not used in last 6 months any medication that could improve/interfere with glucose control or for weight loss

Oregon Health and Science University | Portland, Oregon
Please contact Deborah Branigan at 503-418-9070
Email: diabetesresearch@ohsu.edu

TINSAL-FISH Study

The OHSU Harold Schnitzer Diabetes Center (PI: Dr. Rodica Busui, MD PhD) is part of a multicenter trial funded by the National Institute of Health to identify new therapies that could reverse diabetic neuropathy, a very common and challenging complication of diabetes that leads to nerve damage and loss. The trial is evaluating whether fish oil, alone and in combination with salsalate, a drug approved to treat arthritis may be effective to treat diabetic peripheral neuropathy, and identify new targets that could be tested in a future trial. This study is being conducted at the University of Iowa, at the University of Michigan, and Oregon Health and Sciences University (OHSU).

Key Eligibility Criteria:

• Are 18 years or older
• Have type 2 diabetes
• Have an HbA1c at screening less than 9.5%

Duration: About 6 months.

If you are interested or would like more information, please contact the study coordinator Ariel Miyama at 503-830-9571 or email miyama@ohsu.edu.

OHSU IRB# 27479