Diabetes Clinical Trials in Boston, MA

A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis. Read Less

Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD. Read Less

The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \>30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life. Read Less

Though the Mississippi Delta has a rich agricultural history and some of the nation's most fertile soil, residents have experienced the legacy of slavery and economic exploitation through food insecurity and poverty for generations. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and \~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. The Delta Growing a Resilient, Enriching, Equitable, Nourishing food System (GREENS) Food is Medicine (FIM) Project, is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. The project's primary goal is to improve health outcomes by creating a FIM intervention. The Delta GREENS FIM Project aims to become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide. Read Less

Antenatal nonstress tests (NSTs) are performed to assess fetal health and are used as a cost-effective test that can be widely administered. However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting. The ability to conduct a clinically valuable test at home would address access to care issues faced by numerous women in the United States and reduce the workload on healthcare clinicians facing a shortage of human resources. This pilot study aims to assess the feasibility and acceptability of home NST monitoring in order to determine whether femomTM could be utilized as an adjunct to routine prenatal care. Patients with high risk pregnancies who are recommended to undergo at least once weekly at 32 weeks testing by the obstetrician will be recruited for participation in this study. Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks. Read Less

The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes. Read Less

The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The investigators will do this by measuring factors in the blood, such as sugars, fats, metabolites, and proteins, after eating a standardized breakfast meal at the first visit and after taking 14 doses of oral semaglutide over two weeks before the second study visit. The food (mixed meal breakfast) we will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat. The investigators hypothesize that understanding how the acute biochemical response to oral semaglutide differs by genetic variation will generate insight into drug mechanisms and type 2 diabetes pathophysiology. Read Less

T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes. Read Less

The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are: * Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? * Does a ketogenic diet improve diabetes control? * Is a ketogenic diet safe, acceptable and sustainable in children with newly diagnosed diabetes? * What are the microbiome, inflammatory and metabolic changes linking diet to β-cell function? Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months. * Diabetes care devices will be connected for cloud-based data collection. * Bi-weekly data downloads and remote check-ins will assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns. * During four study visits held at at baseline, 1, 5, and 9 months, an intravenous catheter (IV) will be placed for collection of 5 blood samples before and up to 2 hours after a liquid test meal (protein shake) to assess insulin response. A stool sample will also be collected to assess microbiome changes. * Children and their caregivers may be invited to participate in a semi-structured interview, and online questionnaires to assess their experience with the diet and diabetes care, general well-being and quality of life. * Children and their caregivers may be invited to participate in a follow-up visit to evaluate long-term effects after 24 months. Comparison will be made between a ketogenic vs standard diet. Read Less

The overall goal of the study is to create a standardized, stakeholder-informed system within EMRs, that will enable an equitable and regular prescription and documentation of advanced diabetes technologies. This will reduce racial disparities and generate an understanding of the reasons behind prescription decisions. The study will highlight the development and implementation an EMR-based Best Practice Advisory (BPA). The study will answer whether the EMR-based BPA can effectively reduce disparities. Additionally, it will explore why providers may not prescribe advanced diabetes technologies. Patients will also be surveyed to understand their perspectives on developing the EMR-based BPA. Read Less

This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D). This observational study will: * follow participants to determine how long they continue to produce insulin, and * will also assess how changes in the immune system over time relate to the ability to produce insulin. This information could help design better therapies for type 1 diabetes in the future. Read Less

The aim of this protocol is to assess the presence and severity of primary aldosteronism pathophysiology in patients with type 2 diabetes who have, or are at-risk for developing, chronic kidney disease. Read Less