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!
Read more about the Clinical Trials that are currently recruiting below:
Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet: Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate diet.
To test the feasibility of this approach, the investigators will conduct a randomized-controlled feeding study involving 32 adults and adolescents with T1D. 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. They will share continuous glucose monitoring data with the study team and be in close communication to adjust insulin doses as needed. All participants will have a screening visit, an individual or group education session, and 7 study visits with fasting blood draws to evaluate diabetes control and metabolic health. Two of the visits will also comprise additional metabolic studies to assess glucagon response and brain function during hypoglycemia by magnetic resonance imaging (MRI). Participants will have IV catheters placed and receive IV insulin to drop blood glucose levels to 50 mg/dl for up to 30 minutes. The primary outcome will be HbA1C change from baseline. Secondary outcomes include detailed measures of glycemic variability, metabolic health, and quality of life.
Prevention Bio PROTECT Study: This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis). Approximately 300 participants will be randomized at a ratio of 2:1 to either the teplizumab group or the placebo group. Teplizumab or matching placebo will be administered in two courses 6 months apart. Each course of treatment will include daily infusions for 12 days. The total study duration for each participant will be up to 86 weeks. The primary objective is to determine whether two courses of teplizumab administered 6 months apart slows the loss of β cells and preserves β cell function over 18 months (78 weeks) in children and adolescents 8-17 years old who have been diagnosed with T1D in the previous 6 weeks. The secondary objectives are to evaluate improvements in key clinical parameters of diabetes management, to determine the safety and tolerability of teplizumab, and to evaluate the pharmacokinetics (PK) and immunogenicity of teplizumab.
- Recruitment: You may be eligible if you were diagnosed with type 1 diabetes within the last 6 weeks and are between the ages of 8 and 17.
- Contact: For more information about the Provention Bio PROTECT Study, please email firstname.lastname@example.org or call 908-356-0514. Additional information can also be found at www.theprotectstudy.com and ClinicalTrials.gov.
Avotres Cell-Based Therapy Study: This study aims to determine if we can safely correct a defect in the immune system that most people with type 1 diabetes have, to reduce the immune system’s attack on the insulin-producing beta cells. Your own blood cells will be used to develop a treatment specific to you. Two-thirds of participants will be randomly assigned to receive the active study treatment, and one-third will be assigned to receive an inactive placebo. Neither you nor the research team will know which group you are in. The study will include Physical examinations, blood draws, blood cell collection (leukapheresis), a series of 3 infusions of the treatment (or placebo) with one month between each infusion, and Mixed-Meal Tolerance Tests to monitor beta cell function.
- Recruitment: You may be eligible if you were diagnosed with type 1 diabetes within the last 12 months, are age 18 or older, and are not pregnant, breastfeeding, or planning to become pregnant during the duration of the trial.
- Contact: For more information about the Avotres Cell-Based Therapy, please download the recruitment brochure and email T1DTrials@joslin.harvard.edu or call 888-813-8669. Additional information can also be found at ClinicalTrials.gov.
Tolerion SUNRISE Study: The purpose of this study is to evaluate the safety of an investigational drug called TOL-3021, and to evaluate whether TOL-3021 can stop the immune system from attacking the insulin-producing beta cells in the pancreas of individuals with type 1 diabetes. TOL-3021 is what is known as a DNA vaccine. The active ingredient of TOL-3021 is a piece of DNA that contains the information needed for a cell to make insulin. TOL-3021 is administered at home by weekly intramuscular injections. It is believed that TOL-3021 will cause the muscle cells to present insulin pieces to the immune system in a way that may cause the immune system to become more accepting of cells that make insulin. Two-thirds of participants will be randomly assigned to receive the active study treatment, and one-third will be assigned to receive an inactive placebo. Neither you nor the research team will know which group you are in. The Study will include Physical examinations, eye imaging, blood and urine testing, Mixed-Meal Tolerance Tests, weekly study drug injections, and continuous glucose monitoring (required for the first year of the study).
- Recruitment: You may be eligible if you were diagnosed with type 1 diabetes within the last 5 years, are between the ages of 18 and 40, and are not pregnant, breastfeeding, or planning to become pregnant during the duration of the trial.
- Contact: For more information about the Tolerion SUNRISE Study, please download the recruitment brochure and email T1DTrials@joslin.harvard.edu or call 888-813-8669. Additional information can also be found a tolerioncc.com and ClinicalTrials.gov.
MGH Bone Health in Type 1 Diabetes Study: The purpose of this research study is to investigate the influence of type 1 diabetes on bone health and development in young people. The risk of broken bones is significantly higher among both children and adults with type 1 diabetes compared to those without diabetes. This study aims to investigate how type 1 diabetes alters bone strength, with the long-term goal of improving bone health. Participants in this study will visit the MGH main campus three times over the course of two years and will undergo a brief physical exam, blood and urine tests, x-rays, questionnaires, and measurements of physical activity.
- Recruitment: You may be eligible to participate if you are between the ages of 6 and 20 years. We are looking for volunteers both with and without type 1 diabetes. Participation is compensated up to $300.
- Contact: For more information about the bone health study, please download the recruitment brochure, or email email@example.com or call 617-724-3255.