Clinical Trials and Studies Now Enrolling

There are several research clinics and institutes that are seeking participants for their studies and clinical trials right now! Please see below to find a clinical trial that appropriate for you. Also, if you have specific questions about clinical trials that might be appropriate for you, please reach out to our PNW Chapter Clinical Trial Education Volunteers (CTEV) Laura Tremblay ([email protected]), Jude Restis ([email protected]), Julie Geddes ([email protected]) and/or Mark Smith ([email protected]).

*Note: Watch August 13th’s Pacific Northwest Research & Clinical Trials Quarterly Update here to learn more about some of the clinical trials mentioned below and where we’re at with recent T1D breakthroughs in research!

BENAROYA RESEARCH INSTITUTE – SEATTLE

If interested in any of these studies or have any questions, please contact:  [email protected], 1-800-888-4187.

RESET-T1D

This study is testing whether an investigational medicine, called rezpegaldesleukin (“rezpeg”), can preserve insulin secretion after diagnosis. Rezpeg is given as an injection every 2 weeks for 6 months, followed by 6 months of monitoring after treatment stops.

You may be eligible for this study if you:

  • Are 18-45 years old. Younger cohorts will be enrolled later in the study, eventually down to age 8 years
  • Newly diagnosed with T1D (enrolled in the study within 100 days of diagnosis)

βETA PRESERVE Study

This study is looking at how an investigational study drug, called teplizumab, might possibly help protect insulin producing cells by affecting the immune cells that attack them.

You may be eligible for this study if you:

  • Are 1 – 25 years old
  • Have been diagnosed with T1D within the past month

This study is also enrolling at Rocky Mountain Clinical Research – Idaho Falls (below).

SAFEGUARD Study

This study will evaluate the safety and efficacy of an investigational medicine called SAB-142 in delaying disease progression in people newly diagnosed with T1D.

You may be eligible for this study if you:

ASCEND T1D

The ASCEND T1D Study is testing anti-thymocyte globulin (ATG) and teplizumab to compare their ability to delay the onset of type 1 diabetes (T1D) in people at high risk.

You may be eligible for this study if you are:

  • Ages 4 to 34
  • Stage 2 T1D confirmed by TrialNet testing (at least 2 diabetes-related autoantibodies and abnormal glucose tolerance)
  • Not diagnosed with Stage 3 T1D (clinical diagnosis)

Benaroya Research Institute Autoimmune Registry

The Benaroya Research Institute Autoimmune Registry (BRIAR) is a voluntary registry for individuals interested in participating in autoimmune disease research. Whether you live with an autoimmune condition, have a family member who does, or would like to be a healthy control volunteer, joining BRIAR helps advance scientific understanding and supports the development of future treatments.

You are eligible to join BRIAR if you have any of the following:

  • a personal history of one or more autoimmune/immune-mediated condition(s)
  • a healthy immune system, without any autoimmune/immune-mediated conditions
  • a family history of one or more autoimmune/immune-mediated condition(s)

Parents or legal guardians may register on behalf of a child under age 18.

By enrolling, you will provide basic health information that helps us match you to current and future studies, and you will receive periodic research updates from Benaroya Research Institute (BRI). All the information you provide will be kept confidential and participation in future studies is always voluntary

ROCKY MOUNTAIN CLINICAL RESEARCH – IDAHO FALLS

βETA PRESERVE Study

This study is looking at how an investigational study drug, called teplizumab, might possibly help protect insulin producing cells by affecting the immune cells that attack them.

You may be eligible for this study if you:

If interested in βETA PRESERVE, please contact [email protected], 208-522-6005

This study is also enrolling at Benaroya Research Institute – Seattle (above).

OHSU – PORTLAND

SUGARNSALT

This trial is determining if an investigational oral medication called Sotagliflozin (SOTA) can help slow kidney function decline in patients with type 1 diabetes. SOTA is a drug in the family of medications called SGLT1 and SGLT2 (sodium/glucose transport) inhibitors and is currently approved by the FDA to reduce the risk of being admitted to the hospital due to heart failure in persons with type 2 diabetes and other conditions. Some studies have shown that drugs like SOTA may also slow the progression of kidney disease in people with and without diabetes.
You may be eligible to participate if you are:

  • Diagnosed with type 1 diabetes for at least 8 years and continuously treated with insulin
  • Between the ages of 18 and 75 years
  • Have been told by your doctor that you have diabetic kidney disease or protein in your
    urine

If you are interested in participating in this trial, please contact OHSU study staff (Aly Carlson or Krista Metas) by phone or email:
Aly Carlson: 971-610-3005
Krista Metas: 971-484-5758
Email: [email protected]

Development and Evaluation of App-Based Certified Diabetes Education (AB-CDE) Study

This 38-week clinical research study aims to evaluate how advanced technology, and personalized support can help people with type 1 diabetes improve their glucose control.

Participants will use several innovative tools, including the Dexcom G6 continuous glucose monitor (CGM), an insulin dose capture system (Tempo pens and Tempo button), and the DailyDose app, which provides tailored insulin dosing recommendations. Each participant will also receive an iPhone and Apple Watch to collect data on sleep and physical activity. After a two-week run-in period, participants will be randomized into either a control group of an intervention group.

Those in the intervention group will receive training to use the full DailyDose system, which provides personalized insulin dosing recommendations based on glucose, insulin, meal, and exercise data phase whereas control group will continue standard data logging which involves use of the Dexcom G6 CGM, the insulin dose capture system (Tempo pens and Tempo button), and the Data-logging Mode of DailyDose for the entire study.

The AB-CDE Study aims to demonstrate how digital tools and behavioral support can empower individuals with type 1 diabetes to achieve better long-term health outcomes.

You may be eligible for this study if you:

  • Are 18 years old or older
  • Have been diagnosed with T1D for at least one year
  • Have an HbA1c 7.5-11%
  • Use multiple insulin injection therapy

If you are interested in participating in this trial, please contact OHSU study staff (Samrita Thapa or Matthew Howard) by phone or email:

Samrita Thapa: 503-494-8421

Matthew Howard: 503-418-2209

Email: [email protected]

UNIVERSITY OF WASHINGTON – SEATTLE

CNP-103

This study is looking at the safety, tolerability, pharmacodynamics, and efficacy of CNP-103. CNP-103 is an investigational, first-in-class, antigen-specific therapy. CNP-103 is designed to preserve insulin production by targeting the autoimmune attack on beta cells, which may improve blood sugar control and long-term outcomes.

You may be eligible for this study if you:

  • Are 18-35 years old
  • Were diagnosed with T1D within 180 days (6 months)

If interested, please contact: Dori Khakpour, [email protected]

REMODEL T1D

REMODEL T1D is looking at the potential benefits of the GLP-1 agonist, Semaglutide, on kidney function in people with abnormal kidney function due to T1D.  A secondary objective is to study the glycemic effects of Semaglutide in people with T1D.  The study will last 26 weeks, including a gradual titration of study medications to maximum target dose over 12 weeks, followed by evaluation of the effect of Semaglutide on the kidney. Evaluation will include kidney MRI, urine testing and blood testing.

You may be eligible for this study if you:

  • Are 18 years of age or older
  • Have been diagnosed with T1D for at least 5 years
  • Have abnormal kidney function due to T1D
  • Are on stable doses of medications for blood pressure and cholesterol

If interested, please contact: Darinka Gil, [email protected]

T1-DISCO – Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

The purpose of this study is to learn more about the effects of an investigational drug called semaglutide (Ozempic™), as a safe and effective means of improving cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. Semaglutide is considered investigational because it is an FDA-approved drug being used off-label. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. UW will perform a randomized study to assess the effects of 8 months of once weekly subcutaneous semaglutide vs. once weekly placebo injections. If participants join the study, they will have one screening visit, one 8-month treatment phase, two long study visits, two MRI visits, four interim visits, and one follow-up visit over approximately 9 months. They will be asked to take the study medication or a placebo, for a period of 8 months.

If interested, please contact: Amanda Bard, [email protected]

SUGARNSALT

This study involves taking a tablet of sotagliflozin (SOTA) or an identical tablet without any active drug (200 mg) every day for about  3 years and 4 months. The study involves 19 study visits including one that can be done over the phone. SOTA is currently approved to reduce the risk of being admitted to the hospital due to heart failure, or dying of cardiovascular disease, in persons with type 2 diabetes and other conditions. SOTA is not currently approved to improve glycemic control in patients with type 1 diabetes. SOTA is also not currently approved to slow progression of kidney disease in diabetes. However, the FDA has reviewed this study and has granted the investigators permission to use SOTA to investigate whether it can have a beneficial effect on kidney function in type 1 diabetes. 

Participants  will receive $50 for each study visit, except visit 5, which is a short visit done at the same time as visit 4 or as a brief telephone call. If interested, please contact: Anjali Kumari, [email protected]

INHALE AID Ex Study

INHALE AID Ex is an inhale insulin study for those with T1D on Tandem t:slim X2 insulin pump with control-IQ. The study wants to see if inhale insulin given for a meal is safer and better to use than a bolus of insulin through the pump when exercise follows a meal. About 30 people will be in the study at 3 sites in the U.S.

You may be eligible for this study if you:

  • Have Type 1 Diabetes and are between 18 and 60 years of age
  • Use a Tandem insulin pump with Control IQ
  • Are physically active, currently doing exercise sessions
  • Can complete a 45-minutes brisk walk on a treadmill
  • Would like to help us determine if taking inhaled insulin at mealtime causes less low blood sugar during exercise compared to Novolog or Humalog

Can you attend 4 visits in clinic? Compensation for your time and travel provided.

If interested, please contact: Jessica Baran, [email protected]

SEATTLE CHILDREN’S HOSPITAL

MANATEE T1D

Metformin and Automated Insulin Delivery system effects on renal vascular resistance, insulin sensitivity, and cardiometabolic function in youth with type 1 diabetes.

This study is a randomized, double-blind, placebo-controlled trial being conducted at Seattle Children’s Hospital. The purpose of this study is to learn about the health effects on the kidney, blood vessels, and insulin sensitivity of combining two treatments – an automated insulin delivery system and metformin – for people ages 12-25 years old who have had type 1 diabetes for at least 6 months. Participants can be using either an insulin pump or multiple daily injections (MDIs). The use of metformin in this study is experimental. Study participants will be randomized to receive metformin or a placebo for the study period of 4 months.

If interested, please contact: Kevin Bocek, [email protected], 206-643-5599 or Amelia Johnson, [email protected].

WAVE T1D

This study is being done in people with newly diagnosed Type 1 Diabetes (T1D) to see if using a treatment called Anti-thymocyte Globulin (ATG), followed by either Adalimumab or Verapamil, can help people keep making insulin for a longer time which may also help control blood glucose. Participants will be in the study for up to 3 years, including approximately 12 office visits and at least 6 scheduled phone contacts.

You may be eligible for this study if you:

  • Have been recently diagnosed with T1D and can start the treatment phase within 6 months of your diagnosis.
  • Are between 9 and 20 years old
  • Weigh more than 66lbs
  • Can read and understand English or Spanish
  • Are up-to-date on recommended vaccines for your age and willing to avoid certain live vaccines during the study
  • Use only insulin to control blood sugar (no other glucose-lowering medicine)

If interested, please contact: Kevin Bocek, [email protected], 206-643-5599 or Amelia Johnson, [email protected].

RAINIER CLINICAL RESEARCH CENTER – RENTON 

If you are interested in one or more of the trials below or have any questions, please contact the Site Coordinator at RCRC at [email protected] or call 888-478-8343.

OP-T Study

This study is looking to explore the effects of subcutaneous study medication on sustaining or increasing C-peptide production in those diagnosed with T1D. The study medication blocks a major mechanism of the immune attack on beta cells. C-peptide levels are a by-product of insulin production. When insulin production rises, C-peptide levels increase. Parts B and C of the study are currently enrolling. Participants may receive study drug or placebo with a total participation of 48 weeks.

You may be eligible for the Part B enrollment group if you:

  • Are 18-50 years old
  • Have been diagnosed in the last 1-10 years

You may be eligible for the Part C enrollment group if you:

  • Are 18-50 years old
  • Have been diagnosed in the last 12 months

MOON

This study is looking at an overnight insulin pump system, called Luna, worn only while sleeping. The pump is intended to address hyperglycemia during sleep. The system is worn during sleep, following the participant’s last bolus insulin dose, and removed upon waking prior to their first bolus insulin dose. The study participation period is up to 5 weeks, with a total of 3 overnight visits in the clinic under the supervision of a healthcare provider. After the overnight visits, participants will use the Luna device for 15 days in an outpatient setting. Compensation is up to $1600.

You may be eligible if you:

  • Are an adult living with type 1 or type 2 diabetes
  • Experience hyperglycemia during sleep
  • Use insulin to treat your diabetes, but are not currently on an insulin pump
  • Have used a CGM for at least the last 3 months

Two New CGM Studies for MiniMed (Medtronic’s) Novel ‘Unity’ Sensor

There are two upcoming opportunities to test the accuracy of Medtronic’s newly developed ‘Unity’ CGM. The first study is 32-day wear period (two 16-day periods) and involves 4 longer in-clinic frequent sample testing (FST) visits. Participants may roll from this study into the second study (described below) with a 2-week waiting period in between.

The second study is designed to test the algorithm of the sensor, involving a 16-day wear period and 4 FSTs in-clinic including hypoglycemia and hyperglycemia challenges. Participants may repeat this study multiple times as long as there is an 8-week gap between start and finish.

Two Additional Upcoming Studies for Senseonics’ Novel Year-Long CGM

Senseonics is moving to develop its Gemini CGM System to offer Bluetooth capabilities, eliminating the need for an externally-worn transmitter with the commercially available Eversense 365 sensor. The company is planning to test the evolution of Gemini over 2 upcoming studies, expected to start this summer:

Senseonics 0050: Subjects will have two sensors inserted, one in each upper arm with the Eversense 365 CGM inserted in the primary arm and the Gemini System inserted in the secondary (blinded) arm. The Gemini System will be blinded for the duration of the study. Expected study duration is 14 months and participants will be required to take part in five 8-hour frequent sample testing (FST) visits in the clinic throughout the study. Daily self-monitoring of blood glucose using a glucometer is also required.

Senseonics 0052: Subjects will have two sensors inserted, one in each upper arm with the Gemini System.  Both Gemini Systems will be blinded for the duration of the study. Similar to Senseonics 0050, the study’s expected duration is 14 months and participants will be required to take part in five 8-hour frequent sample testing (FST) visits in the clinic throughout the study. Daily self-monitoring of blood glucose using a glucometer is also required.

Find a Clinical Trial Near You!

If the above clinical trials and studies don’t work for you, you can utilize Breakthrough T1D and Antidote’s Clinical Trial Connection Tool to find one that resonates with you! To utilize this tool visit this link, or if you want to learn more about Clinical Trials in general, visit here.