Participate in a Clinical Trial

Greater Twin Cities Metro

U of M – Clinical Trials (6)

(1 of 6) For those with a family history of T1D:

• TrialNet screening is offered at no cost to eligible individuals to evaluate their personal risk of developing T1D. This unique screening can identify the early stages of T1D years before any symptoms appear.  It also helps researchers learn more about how T1D develops and plan new studies exploring ways to prevent it. Eligible participants are between the ages of 2.5 and 45 years and have a parent, brother/sister, or child with T1D, between the ages of 2.5 and 20 years and have an aunt/uncle, cousin, grandparent, niece/nephew, or half-brother/sister with T1D, and have NOT been diagnosed with T1D.
• Ages: 2.5-45 or 2.5-20
• Contact: Beth Pappenfus 612-624-2922 peds-diabetes@umn.edu

(2 of 6) For adults with T1D:

• FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults with Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis (DKA).
• Ages:  18-65
• Contact:  Jacob Kohlenberg, endoresT1DDM@umn.edu

(3 of 6) For adults with T1D:

• CLEAR (Closed Loop and Education for hypoglycemia Awareness Restoration): The purpose of this study is to learn how to improve hypoglycemia unawareness. This study will use different types of education and devices to see if they can help people become more aware when the blood sugar is low.
• Ages:  18-75
• Contact: Elizabeth Seaquist, seaqu001@umn.edu

(4 of 6) Newly Diagnosed with T1D within 100 days:

• The TADPOL study is investigating whether an oral medication called DFMO (difluoromethylornithine) can help preserve beta-cell function in people newly diagnosed with T1D. This Phase 2 trial is open to participants ages 4 to 40 who are within 100 days of diagnosis and have normal hearing. DFMO has shown potential in other autoimmune conditions, and researchers are exploring what it can do for those newly diagnosed with T1D.
• Ages: 4-40
• Contact: PEDS-DIABETES@UMN.EDU

(5 of 6) Newly Diagnosed with T1D within 180 days:

• The COUR study is a Phase 1 trial focused on safety. CNP-103, nanoparticle IV, is a groundbreaking disease-modifying approach which encapsulates 4 recombinant proteins that cover more than 95% of the antigens that drive T1D. Participants must be between 12 and 35 years old, weigh at least 50 kg, and be within 180 days of diagnosis.
• Ages: 12-35
• Contact: PEDS-DIABETES@UMN.EDU

(6 of 6) Newly Diagnosed with T1D within 6 months:

• WAVE T1D is a Phase 1/2 trial evaluating a multi-drug strategy: ATG (an IV immunotherapy) followed by either adalimumab (a subcutaneous anti-inflammatory) or verapamil (an oral calcium channel blocker). The goal is to assess the safety and efficacy of the therapy combinations in preserving insulin secretion 2 years from randomization in persons with recent-onset stage 3 T1D. Eligible participants are ages 9 to 21, within six months of diagnosis, and weigh more than 30 kg.
• Ages: 9-21
• Contact: PEDS-DIABETES@UMN.EDU

HealthPartners International Diabetes Center (2)

(1 of 2) Newly diagnosed T1D within a month:

• BETA-PRESERVE: A randomized, double-blind, Phase 3 study to investigate efficacy and safety of teplizumab compared with placebo in participants 1 to 25 years of age with recently diagnosed Stage 3 Type 1 Diabetes (T1D).
  • Purpose of 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. The main goal of the study is to see if teplizumab can work better than a placebo (a look alike with no medicine in it) in helping people keep their blood sugar in a healthy range or use less mealtime insulin. Teplizumab is already FDA approved for use in earlier-stage of type 1 diabetes.
  • Ages: 1-25
  • Contact: Caitlin Moening, (952) 993-9605, IDCResearch@parknicollet.com, Diabetes – HealthPartners Institute or Sanofi Studies

(2 of 2) For adults with T1D for at least 1 year:

• ONWARD 11:
  • Purpose: This study is comparing the safety and efficacy of once weekly icodec long-acting insulin versus once daily glargine (Lantus) long-acting insulin, both in combination with fast-acting insulin aspart (Novolog).
  • Ages: 18 years and older
  • You may be eligible for this study if you:
    • Have been diagnosed with T1D for at least one year
    • Have an A1C 7.0%-10.0%
    • Have been using multiple daily injections (MDIs) for at least 6 months before screening
  • Contact: Caitlin Moening, (952) 993-9605, IDCResearch@parknicollet.com, Diabetes – HealthPartners Institute

Rochester

Mayo Clinic

(1 of 3) Newly diagnosed T1D within a month:

• BETA-PRESERVE: A randomized, double-blind, Phase 3 study to investigate efficacy and safety of teplizumab compared with placebo in participants 1 to 25 years of age with recently diagnosed Stage 3 Type 1 Diabetes (T1D).
  • Purpose of 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. The main goal of the study is to see if teplizumab can work better than a placebo (a look alike with no medicine in it) in helping people keep their blood sugar in a healthy range or use less mealtime insulin. Teplizumab is already FDA approved for use in earlier-stage of type 1 diabetes.
  • Ages: 1-25
  • Contact: Daine Shieluh Livingood, (507) 255-2914, DaineShieluh@mayo.edu

(2 of 3) For adults with T1D for at least 1 year:

• Automated Insulin Delivery in Elderly with Type 1 Diabetes
  • Purpose: The study is being done to find out if low blood sugar (hypoglycemia) can be reduced in people with type 1 diabetes (T1D) 65 years and older with use of automated insulin delivery (AID) system.
  • Age ≥ 65
  • Contact: Shelly McCrady-Spitzer M.S., (507) 255-5916, Shelly@mayo.edu

(3 of 3) For adults with T1D

• PACTAID
  • The purpose of this trial is to test and refine the PACTAID smart phone application in adults with type 1 diabetes mellitus to help manage exercise while on automated insulin delivery systems with the goal of improving glycemic control during and after exercise as well as improving multiple other cardiovascular risk factors.
  • Ages: 18 to 65
  • Contact: Leidy Plaza Enriquez M.D., (507) 284 2476
    Leidy@mayo.edu

Western Minnesota, North Dakota and South Dakota

Sanford – Clinical Trials

(1 of 1) For those with a family history of T1D:

• Pathway to Prevention: TrialNet screening is offered at no cost to eligible individuals to evaluate their personal risk of developing T1D. This unique screening can identify the early stages of T1D years before any symptoms appear. It also helps researchers learn more about how T1D develops and plan new studies exploring ways to prevent it. Eligible participants are between the ages of 2.5 and 45 years and have a parent, brother/sister, or child with T1D, between the ages of 2.5 and 20 years and have an aunt/uncle, cousin, grandparent, niece/nephew, or half-brother/sister with T1D and have NOT been diagnosed with T1D.
• Location: In home or lab test kit
• Ages: 2.5 -45 or 2.5 to 20 depending on above criteria
• Contact: Sanford Fargo Region: (701) 234-2383 or Sanford Sioux Falls Region: (605) 328-1368

Virtual Clinical Trials

(1 of 8) For female-identifying T1Ds ages 15-30 experiencing disordered eating:

• The Diabetes Body Acceptance Project is conducting a research study comparing two programs designed to improve body acceptance, reduce body image concerns, and reduce disordered eating behaviors. Female-identifying individuals between the ages of 15-30 with T1D who have body image concerns and/or struggle with disordered eating behaviors are invited to participate. Depending on the program you are randomized to you will attend weekly one-hour groups for 6 weeks (virtual for our chapter area) or watch one hour of videos each week.
• Age: 15-30
• Contact: https://redcap.link/thsinterest or diabetesbodyacceptance@standford.edu

(2 of 8) For T1Ds, loved-ones, and supporters:

• The T1D Exchange Registry is a research study, conducted over time, for individuals with type 1 diabetes and their supporters. Participants volunteer to provide their data for research (for example, by answering questions in annual surveys).  Once enrolled, Registry participants can sign up for other studies on various topics related to type 1 diabetes.
• Age:  Any
• Contact:  Kelsie, LaFerriere@t1dexchange.org or Carolina Leon, cleon@t1dexchange.org
• Want to stay connected to clinical trials in the future? Check out the T1D Exchange:
• https://t1dexchange.org/registry/

(3 of 8) Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes (ReDUCe)

• The ReDUCe Study is recruiting participants 18-64 living with T1D for at least 6 months and an A1C >7.5%. The study will use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in adults with type 1 diabetes.  For more information please visit: https://montefioreeinstein.org/research/clinical-trials/study/NCT05000021
• Age: 18-64
• Contact: Jeffrey Gonzalez, 646-592-4506, jeffrey.gonzalez@einsteinmed.edu

(4 of 8) Telemedicine-Delivered Unified Protocol for Cognitive Behavior Therapy for Anxiety and Depression (UP-CBT)

• This study is recruiting participants aged 18-35 living with T1D for > 6 months, A1C 7.5-14%, with anxiety or depressive mood disorder. This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in young adults with type 1 diabetes. Click for additional details.
• Age: 18-64
• Contact: Jeffrey Gonzalez, 646-592-4506, jeffrey.gonzalez@einsteinmed.edu

(5 of 8) CGM Data Sharing in Older Adults with T1D

• This study is recruiting participants aged 60+ currently using a CGM with an A1C 7.5-11%. The purpose of this study is to test the Share plus intervention aimed at improving the use of data sharing between people with diabetes and their care partners in order to maximize the benefits of continuous glucose monitoring. Click here for additional information.
• Age: 60+
• Contact: Nancy A Allen, PhD at Nancy.allen@nurs.utah.edu or 801-582-3892

(6 of 8) Diabetes Care in School Survey

• This survey is recruiting caregivers of school aged T1Ds. This survey was developed to assess the experience of families with children and adolescents with type 1 diabetes and their care during the school period. It was translated into different languages and will be shared in various parts of the world, identifying the barriers to diabetes care during the school period in different countries and guiding the measures that can be taken to improve school diabetes care globally. Click here to participate.
• Age: Caregivers of adolescents

(7 of 8) The Teen Interview on Diabetes Eating Survey (TIDES)

•  This study is recruiting participants aged 13-17 living with T1D. Researchers at the Miriam Hospital are interested in learning how teens answer questions related to eating and diabetes management. The goal of this study is to create a questionnaire about eating and diabetes specifically for persons with type 1 diabetes that can be used in clinics and other research studies. Click here for more information.
• Age: 13-17

(8 of 8) Extended Bolus in a Closed-Loop System for Teens

• The University of California, San Francisco is running a virtual study for participants ages 13-18 who use Control IQ to look at the impact of bolus timing on fat/protein. Click here for more information or to sign up.
• Age: 13-18
• Contact: rebecca.wesch@ucsf.edu

• Child is diagnosed with type 1 diabetes and not receiving occupational therapy services
• Child is 2-11 years of age
• Has reliable internet access
• Lives at least 1 hour away from a pediatric endocrinology clinic in North Carolina, Nebraska, Kansas, or South Dakota

• Continuous glucose monitor training
• 14-week supply of continuous glucose monitors
• 12-weeks of occupational therapy telehealth coaching
• $25 gift card for survey and interview participation (3 times total), for $75 total.

Meet your Clinical Trials Education Volunteers:

Angie Grant – anggrant@hotmail.com

Debbie Evans – debbieaevans1@gmail.com