Greater New England Chapter
Participating in a clinical trial is a great way to contribute to curing, preventing, and treating type 1 diabetes (T1D) and its complications. Learn more below about the clinical trials currently recruiting in your area as well as Breakthrough T1D's easy tool to match you with a clinical trial in 60 seconds.
Choosing to participate in a T1D clinical trial is a very personal decision, but one that can have a significant impact on curing, preventing and treating T1D. There are many opportunities in the Greater New England area to participate in a T1D clinical trial close to home. See below for active opportunities.
Additionally, Breakthrough T1D has an easy-to-use tool called the Clinical Trials Connection where you can match with a clinical trial in 60 seconds. It asks users some simple questions about themselves before matching them with trials for which they are eligible. Clinical Trials Connection uses your city, distance you’re willing to travel and other characteristics to narrow down hundreds of trials to the ones in which you might be interested. Start your search by visiting breakthrought1d.org/impact/research/clinical-trials today!
Quick Flyer Links:
If you have any questions, please contact our Greater New England Chapter Clinical Trials Education Volunteers, Amanda Gilchrist and Kristin Neff.
Updated: October 17, 2024
VIRTUAL
The T1D Parent Check In study is recruiting parents/caregivers of T1D patients ages 8-17 received T1D care at MGH or BCH diagnosed within 3-12 months. The goal of this clinical trial is to learn how to best support families during the first year of a child or teen’s Type 1 diabetes (T1D) diagnosis. This three-session intervention is delivered by diabetes psychologists over telehealth with the goal of helping families adjust to T1D, build resilience, and improve children’s long-term health.
The USF Mindfulness App study is recruiting participants aged 12-19 living with T1D for at least 6 months. The University of South Florida is conducting the study to learn more about mindfulness for adolescents with T1D.
The CGM Data Sharing Older Adults 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.
The BEADT1D (Building the Evidence to Address Disparities in Type 1 Diabetes) study is recruiting families of color covered by public insurance to complete surveys and answer questions by interview by the team. They are interested in the perspectives of parents of youth with T1D and youth with T1D aged 12-21 years.
The T1DAL study is recruiting participants aged 13-18 living with T1D for at least 6 months. The goal of the TIDAL Study is to test out a new healthy lifestyles program designed specifically for teenagers with type 1 diabetes. The program is a virtual, group-based program.
The Diabetes Care in School 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.
The TIDES study is recruiting participants aged 13-17 living with T1D. Researchers at the 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.
The Caregiver Stress Levels survey is recruiting caregivers of T1Ds diagnosed within the last 6 months. This survey is examining caregiver stress levels and the relationships that support them among primary caregivers of children and adolescents recently diagnosed with T1D.
The PREME-T1D Project (Parents’ peRspectives on disEase-Modifying thErapy in T1D). is recruiting caregivers of T1Ds. The International Society of Pediatric and Adolescent Diabetes (ISPAD) early career researcher JENIOUS group created this survey, with the support of #dedoc° and INNODIA, to investigate the perspectives of parents/caregivers of children, adolescents, and youth with T1D regarding the use of new disease-modifying drugs, in particular teplizumab.
The Diabetes Teen Wellness study is recruiting female-identifying T1Ds aged 11-17 using a CGM. The Diabetes Wellness Teen Study is investigating risk factors that predict the future onset of body image and eating behavior concerns in adolescents with type 1 diabetes.
The UP-CBT (Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression 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.
The University of Oregon is conducting an online study that aims to better understand the experience of people living with T1D in relation to support and resources. The study is looking for individuals who have been diagnosed for at least 3 months and wear a CGM.
Freestyle Libre 2 or 3 is enrolling patients aged 2-30 with T1D not currently using a CGM in a post-market study evaluating Abbott’s continuous glucose monitor, the Freestyle Libre 2 or 3. Eligible participants will be provided with the Libre at no cost to them for 6 months and will be compensated for their time and efforts participating in the study.
Trial Net 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.
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 or in-person) or watch one hour of videos each week.
University of California, San Francisco is running a virtual study Extended Bolus for Meals in a Closed-Loop System for participants ages 13-18 who use Control IQ to look at the impact of bolus timing on fat/protein.
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.
NEWLY DIAGNOSED
The DIAGNODE-3 study is recruiting participants aged 12-28 within 6 months of T1D diagnosis. The DIAGNODE-3 clinical trial will investigate whether an investigational drug called Diamyd® is able to preserve the body’s own insulin-producing capacity by halting or delaying the immune system’s attack on the insulin-producing cells (beta cells) in the pancreas.
The JAKPOT-T1D Study is recruiting participants aged 12-35 within 100 days of their T1D diagnosis with an A1C <10%. TrialNet researchers are testing two different treatments – abrocitinib and ritlecitinib – to see if either or both can preserve insulin production in people newly diagnosed with type 1 diabetes. Researchers believe these JAK inhibitors may be able to calm the immune system’s attack on cells that make insulin, while also reducing stress to these cells.
The T1D Relay study is recruiting participants ages 8-45 within 100 days of diagnosis. TrialNet is testing rituximab-pvvr and abatacept, one after the other, to learn if using both treatments extend insulin production in people (ages 8-45) who were newly diagnosed with type 1 diabetes (T1D). Each therapy has a history of safety and effectiveness. Rituximab-pvvr is FDA-approved to treat several autoimmune diseases, including Rheumatoid Arthritis (RA). Abatacept is FDA-approved to treat adult Rheumatoid Arthritis, as well as Juvenile Idiopathic Arthritis (JIA) in children as young as six.
The DESIGNATE study is recruiting participants aged 18-45 diagnosed with T1D within 18 months. The goal of this study is to see how the experimental study drug, siplizumab, can block or weaken the cells that attack beta cells in the pancreas. This would allow the beta cells to continue to function and produce insulin.
The STOP-T1D Study is recruiting participants ages 12-35 with stage 2 diabetes (have a 50% risk of developing T1D within 2 years, as defined by having two or more diabetes-related autoantibodies and abnormal blood sugar levels) plus at least one high-risk marker. TrialNet researchers are testing a low dose of the immunotherapy drug anti-thymocyte globulin (ATG) to see if it can delay or prevent type 1 diabetes.
MASSACHUSETTS
Steadiset Extended Wear Infusion Set is recruiting participants aged 18-80 living with T1D for at least 12 months. The study is investigating an extended wear infusion set in adults with type 1 diabetes using a Tandem t:slim X2 insulin pump with Control-IQ technology with continuous Glucose Monitoring (CGM).
The Effects of Ketosis on Brain Function study is recruiting participants aged 18-40 living with T1D for at least 1 year. The study is examining the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with T1D.
The Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes is recruiting participants aged 18-65 living with T1D for at least 5 years on a stable diabetic treatment. This study will evaluate the safety, tolerability, and efficacy of VX-264 infusion in participants with T1D.
The Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes is recruiting participants aged 18-65 living with T1D for at least 5 years and have at least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment. This study will evaluate the safety, tolerability, and efficacy of VX-880 infusion in participants with T1D and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
The Immune Function and Progression to T1D study is recruiting participants with T1D of any age and family members of people with T1D of any age. The purpose of the study is to learn more about the genetics and immune function of T1D by comparing people with the disease to family members and normal controls with no family history.
The PROMISE Study (PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life) is recruiting pregnant women, biological fathers, and their offspring where the offspring has a first degree relative (mother, biological father, full sibling) with T1D. The purpose of this study is to find out more about how exposures during pregnancy, such as having an infection, diet and growth may impact later risk of T1D and islet autoimmunity in the child.
The Multi-Site Eating Disorder Prevention Program for Type 1 Diabetes is looking for participants aged 14-35 living with T1D for at least 1 year and experiencing at least some level of body image concerns. This study aims to test the effectiveness of an evidence-based eating-disorder prevention program specifically targeted for individuals with Type 1 Diabetes (T1D).
The Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet randomized-controlled feeding study is recruiting participants aged 18-40 living with T1D for at least 1 year with Stable glycemic control (HbA1c 6.5-9%) who use a CGM and an insulin pump. Participants will be randomized to receive a very low carbohydrate vs. standard carbohydrate diet. Participants will be in the study for 12 weeks and receive all their meals by meal delivery.
A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes (PERL-FENO) is recruiting participants aged 18-70 living with T1D for at least 8 years with early-to-moderate diabetic kidney disease (DKD) at high risk of ESKD (end-stage kidney disease). The clinical trial is designed to evaluate the effects on the kidney of a generic drug used to lower fats in blood (fenofibrate) that may protect the kidney from damage due to diabetes.
The PRECISION II Study is recruiting participants aged 18-75 living with T1D for at least three months. The purpose of this study is to evaluate the accuracy of the Cambridge Medical Technologies, LLC second generation (2nd Gen) LabPatch glucose sensing system compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite.
The Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes is recruiting participants aged 18-65 living with T1D for at least 5 years and have at least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment. This study will evaluate the safety, tolerability, and efficacy of VX-880 infusion in participants with T1D and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
The Joslin Heart and Kidney Study is recruiting participants ages 25-65 diagnosed with T1D before 41 with normal or moderately decreased kidney function. The goal of this study is to further understand the connection between changes in the cardiovascular system and early kidney disease in people with type 1 diabetes. This information may lead to future prevention and treatment options.
The TANGO Study is recruiting participants with T1D ages 65 and older on MDI or use an insulin pump (Medtronic or Insulet). This study assesses a new technology that aids the communication of health information amongst patients, family members/caregivers, and providers. The study is also looking to determine if this technology is a helpful tool in diabetes management.
The Bone Health in Youth With Type 1 Diabetes study is looking for participants aged 6-20 living with T1D (as well as non-diabetic peers) to participate in an observational study to determine Bone Mineral Accrual and Microarchitecture in children and young adults with T1D. The investigators will examine blood and urine hormone levels as well as measures of bone density. They will also be collecting data regarding physical activity via use of wearable accelerometers.
The Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes is recruiting participants aged 12-17 living with T1D for at least two years. The study is investigating if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on pediatric Type 1 diabetes. Eligible volunteers will either be vaccinated with BCG twice, one month apart or receive a placebo treatment.
The CIAO Study is recruiting participants ages 16-35 or 65+ on MDI. The study uses an electronic dose-recording device with new insulin pen cap technology.
VERMONT
The Eversense® Non-adjunctive Use Post Approval Study (NA-PAS) is recruiting adults with T1D 18 and over not currently using a CGM (continuous glucose monitor). The study is evaluating the effectiveness of Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants. The investigation will include both clinic visits and home use of Eversense CGM System.
Resources
What Are Clinical Trials Video
Match To Clinical Trials in 60 Seconds
Breakthrough T1D and Clinical Trials
Meet Your CTEVs: Amanda Gilchrist
After learning that many clinical trials are slowed down due to low participation, Amanda’s family became involved in this important step to move research forward. In her new role, Amanda is excited to share the importance of clinical trials in T1D research and to encourage T1D families to learn about the many different clinical trial options available to them, both locally and virtually.
Amanda became involved in Breakthrough T1D in 2020 when her then 4-year-old daughter was diagnosed. The community, education, and resources for Breakthrough T1D families was such an incredibly important support following her daughter’s diagnosis. The Breakthrough T1D T1D community and connections became even more important to her family when Amanda was diagnosed with T1D in 2021. With two T1Ds in the family, they have a lot of clinical trial experience to share!
Amanda has a husband (Bob), a daughter (Emmie), and a son (Callen). They live in North Reading, MA and they enjoy spending time as a family reading, visiting Canobie Lake Park, and playing board games. She is excited to take on this volunteer position and looks forward to connecting with you.
Kristin Neff
Kristin was diagnosed with gestational diabetes during her second pregnancy and subsequently diagnosed with type 1 diabetes one year after the birth of her second daughter when she was 30 years old. The diagnosis was unexpected as there was no family history and the connection between gestational diabetes and type 2 diabetes is much more common.
Kristin has been involved in clinical trials for many years but mostly on the operational side conducting clinical studies at various biotech and pharma companies. Kristin knows first hand the challenges associated with recruiting and retaining patients in these critical studies, as well as the importance of clinical studies in the development of new treatments.
Becoming a CTEV allows Kristin to use her passions for clinical studies and T1D in a way that will hopefully motivate others to learn more and get involved.
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