Greater New England Chapter

Participate in a Clinical Trial

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 JDRF's easy tool to match you with a clinical trial in 60 seconds.

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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, JDRF 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 jdrf.org/impact/research/clinical-trials today!

If you have any questions, please contact our Greater New England Chapter Clinical Trials Education Volunteer, Amanda Gilchrist.

Updated: January 9, 2023

FEATURED T1D STUDIES IN GREATER NEW ENGLAND

NEW HAMPSHIRE
The Sweetgoals for Type 1 Diabetes study is looking for participants aged 19-29 living with T1D to test an app and web-delivered intervention designed to improve glycemic control. All participants will receive the “core” digital intervention and the SweetGoals app, focused on self-monitoring and goal setting. Efficacy of two independent intervention components (incentives for adherence and web health coaching) will be tested.

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.

Researchers at the University of Vermont are looking for participants for Activate (The Technology-delivered Physical Activity Program for Adolescents With Type 1 Diabetes). Activate is a 12-week, technology-delivered diabetes behavior-change skills training and physical activity promotion program for adolescents aged 13-17 living with T1D. Participants will either be in the 12 week program or will follow their usual diabetes care plan for 12 weeks. Both groups will receive a Garmin fitness activity tracker wristwatch to track their physical activity.

MASSACHUSETTS

The Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and follow-up (PC-IP) or with training and follow-up via telehealth (PC-TH). As a comparison, the iLet will be initiated by an academic endocrinology practice with either in-person training and follow-up (EN-IP) or with training and follow-up via telehealth (EN-TH). The study is recruiting participants aged 18-85 living with T1D for at least one year. For more information, contact

TOPPLE T1D (A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041) is recruiting participants aged 18-45 living with T1D for less than 4 years. The treatment is a plasmid vector designed to transfer DNA into cells, where it can communicate with the immune system. Earlier studies in the lab show this treatment might retrain the immune system to stop attacking insulin-producing beta cells. While plasmids are small circular pieces of DNA, they do not change your DNA. They are currently being studied in many clinical trials for other conditions.

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.

  • Location: MassGeneral Hospital
  • Age: 6-20
  • Contact: Deborah M Mitchell, MD at dmmitchell@partners.org or 617-724-2034

The Impact of Metabolic Health on Sperm Epigenetic Marks in Humans study is designed to evaluate whether epigenetic markers in overweight men with T1D or T2D can be improved with a three month lifestyle intervention or program focused in glycemic intervention. The investigators are studying the impact of elevated glucose on human reproductive health and the sperm epigenome. The study is looking for males aged 18- 65 with BMI > 25 kg/m2.

The IMPACT Study (IMCY-0098 Proof of ACtion in Type 1 Diabetes) is recruiting participants aged 18-44 with a recent T1D diagnosis (within 9 weeks). The study drug is being developed to stop the body’s own immune system from attacking and destroying the insulin-producing cells. IMCY-0098 was previously tested on recently diagnosed T1Ds to collect information on the safety of the drug. The next step is to test the best dose and the best number of injections that show the drug can give a benefit.

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.

  • Location: Massachusetts General Hospital
  • Age: 18-65
  • Contact: Medical Information at medicalinfo@vrtx.com or 617-341-6777

The INHALE-1 (Afrezza® INHALE-1 Study in Pediatrics) study is recruiting participants aged 4-17 living with T1D. Afrezza (insulin human) Inhalation Powder is the only inhaled ultra rapid-acting mealtime insulin and is currently FDA-approved for adults. The study will assess the efficacy and safety of Afrezza vs. multiple daily injections of insulin, both in combination with basal insulin.

  • Location: Joslin Diabetes Center
  • Age: 4-17
  • Contact: Kerry Milaszewski at 617-732-2603 or visit go.afrezza.com/INHALE1

The Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to Adult Care study is looking for participants aged 18-30 living with T1D. Researchers will compare an innovative care model for young adults with diabetes and those in the usual care model for adult diabetes management at Massachusetts General Hospital (MGH) Diabetes Center. Participants in the research study will be asked to complete a series of three survey questionnaires over the timeframe of the study.

The Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes study is recruiting current users of the t:slim X2 insulin pump with Control-IQ technology who are between the aged 6-80 living with T1D. The study will evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.

The Omnipod 5 System Compared to Pump Therapy study is recruiting participants aged 18-70 living with T1D for at least 1 year who are not currently using automated insulin delivery (AID) devices. Participants will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system.

The Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D) clinical trial is recruiting participants aged 14-25 with type 1 diabetes for at least 1 year and suboptimal diabetes control (A1c 7-13%). This 2-year randomized clinical trial will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes to optimize short-term and long-term health.

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.

  • Location: Massachusetts General Hospital – Immunobiology Labs CNY 149 Charlestown, Massachusetts
  • Age: 12-17
  • Contact: Denise L Faustman, MD, PhD at diabetestrial@partners.org or 617-726-7084

The Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus is recruiting pregnant women 18 years and older with pre-gestational diagnosis of type 1 diabetes who are managed on an insulin pump during pregnancy. Participants must be receiving pregnancy and delivery care at University of Massachusetts (UMass) Memorial Medical Center. The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion.

  • Location: University of Massachusetts Memorial Medical Center Worcester, Massachusetts
  • Age: 18+
  • Contact: Gianna L Wilkie, MD at Gianna.Wilkie@umassmemorial.org or 508-334-4067

The Gladiator Study (A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function) is recruiting participants aged 14-45 with new-onset T1D (within 180 days of diagnosis). This clinical trial will assess whether Ladarixin treatment is effective in preserving beta-cell function and delaying the progression of T1D in adolescent and adult patients.

VIRTUAL

The Jaeb Center for Health Research is recruiting participants aged 18-70 with T1D for at least 2 years for the T1DEXI study. The Type 1 Diabetes Exercise Initiative is a 4-week at-home data collection study. Data contributed by study participants will help researchers to learn more about the effect of exercise on blood sugar.

The Creighton and UNC Diabetes Research and Wellness Lab is looking for parents of children living with type 1 diabetes AND parents of children without diabetes to participate in a research study (Psychometric Testing of the Diabetes Health Management and Distress Scale-Parents of Children (DHMDS-PC) to help develop a healthcare assessment. If you meet the eligibility criteria, you will complete an anonymous online survey, which will take approximately 15 minutes to complete. The survey will include questions about managing your child’s health.

The REDCHiP clinical trial (Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children) is recruiting caregivers of children aged 2-6 living with T1D for at least six months. The purpose of this trial is to examine the efficacy of a real-time video-based telemedicine intervention addressing parental fear of hypoglycemia in families of young children with type 1 diabetes.

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.

 


Meet Your CTEV: 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 JDRF in 2020 when her then 4-year-old daughter was diagnosed.  The community, education, and resources for JDRF families was such an incredibly important support following her daughter’s diagnosis. The JDRF 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.

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