Type 1 & Type 2 Diabetes Clinical Studies and Clinical Trials

Ongoing clinical trials in diabetes at UMass Memorial Health, UMass Chan Medical School and UMass Children's Medical Center are focused on testing new treatment approaches designed to improve quality of life for all people with type 1 and type 2 diabetes.  

Anyone living with diabetes interested in our clinical studies can consent to the registry and sign up for UMass Chan Medical School's monthly research newsletter. Download the enrollment form and check the Diabetes/Endocrine System box.  

Register for a trial or learn more: 

Email Lisa.Hubacz@umassmed.edu

Open & Accruing Studies

Utility and Feasibility of Continuous Glucose Monitoring for Insulin Dosing and Improving Glucose Control in Hospitalized Patients

Asem Ali, MD and Leslie Domalik, MD

The role of continuous glucose monitoring (CGM) is well validated in the out-patient setting, but there are big gaps in our knowledge regarding its use for hospitalized patients. Through this study we will have better information on the utility and feasibility of using CGM in hospitalized patients and be able to compare CGM use to standard fingerstick blood glucose testing in this population.  Funded by a UMass Memorial Health Digital Health Insights (DIGI) grant.

Use of GLP1-RAs in Patients with Diabetes and Established Atherosclerotic Cardiovascular Disease

Madona Azar, MD and Asem Ali, MD

This project addresses an important gap in care delivery for people living with diabetes and established atherosclerotic cardiovascular disease (ASCVD) that is caused by plaque buildup in arterial wall.  In addition to directly benefit patients, the study of glucagon-like peptide-1 receptor agonists (GLP-1 RA) will also educate health care professionals about best practices for diabetes management to improve adherence to standards of care.  Funded by a UMass Memorial Health Digital Health Insights (DIGI) grant.

Continuous Glucose Monitoring in the Intensive Care Unit: Validation and Implementation 

John Mordes, MD, Samir Malkani, MD and Eric W Cucchi MS, PA-C

This clinical study uses the Dexcom G7 continuous glucose monitor (CGM) in the intensive care unit (ICU) environment. The goal is to validate the accuracy and practicality of the Dexcom G7 when used to assess glycemia in critically ill patients by comparing simultaneous CGM readings with glucose measurements obtained in the course of routine care as recorded in the electronic medical record. Funded by a UMass Memorial Health Digital Health Insights (DIGI) grant.

Analyzing Skin Reactions to Continuous Glucose Monitors

Led by UMass Chan Medical School Student Emilee Herringshaw with Samir Malkani, MD, David Harlan, MD, Wei-Che Ko, MD and Cheryl Barry, RN, MS, CDCES

This pilot study was designed to evaluate skin reactions to specific models of CGMs, and characterize severity, location(s) involved, and whether variables such as sensor placement or season of wear impact reactions. The study will also investigate attempted interventions and the results of those interventions.

PBL | Immune Function in Autoimmune Disease 

Dale Greiner, PhD

Seeking volunteer blood donors with type 1 diabetes to be used in our basic research studies to recreate and better understand T1D and other autoimmune diseases. The donated blood will be studied in a replicated human immune system to investigate what causes the body to attack healthy tissues and cause various autoimmune diseases, like type 1 diabetes.

Induced Pluripotent Stem Cells (iPS) 

David Harlan, MD

Scientists are growing stem cell-derived pancreatic beta cells from blood donated by heathy volunteers with type 1 diabetes. People’s own peripheral blood stem cell lines are used to recreate and study human T1D in our novel humanized mice.

PRODMAT | Proliferation Diabetes Mellitus and Adipose Tissue  

Michael Thompson, MD and Silvia Corvera, MD

The location of body fat varies among individuals, with fat deposits in the belly area being a risk factor for diabetes.  The purpose of this research is to characterize how fat cells from the abdomen and buttock regions are different. We'll also study which types of cells in those areas of the body can make new fat cells (stem cells).  Studying fat cells collected from the bellies and backsides of healthy volunteers (18 years and older) and adults with type 2 diabetes to look for differences that might explain what causes diabetes and obesity. Participants will donate fat cells collected using a needle and syringe from their belly and their backside.

Development and Feasibility Testing of DM-BOOST Intervention 

Daniel Amante, PhD

Recruiting men and women with Type 2 Diabetes to serve on an expert panel for a project to develop and test a technology to help people manage their diabetes.  Participants will attend up to two group meetings and two usability testing sessions each year.  DM-BOOST uses clinical informatics tools to identify patients with gaps in diabetes care and deploy tailored, proactive outreach methods rooted in behavioral economics to nudge them towards increased engagement with diabetes self-management training and leverage patient-facing technologies to enhance longitudinal patient self-management support. 

Safety and Effectiveness of an Investigational Booster Vaccine for Covid-19

Jennifer Wang, MD

Seeking men and women who have previously received two doses of the Moderna COVID-19 vaccine for a study of a booster vaccine that is slightly different than the original Moderna COVID-19 vaccine.

How the Flu Affects Blood Cells

Jennifer Wang, MD

Seeking healthy adults and adults who have been suffering influenza-like illness for no more than 14 days for a study of how the flu or flu-like infections affect their blood cells.

Investigating Repurposed Medications for Treatment of Covid-19

Jennifer Wang, MD

Seeking men and women 18 years of age or older who have been diagnosed with and currently have mild or moderate symptoms of COVID-19 to better determine what types of medications may best treat COVID-19.

Clinical Study Archives

 

Benefits of Continuous Glucose Monitors to Reduce Hospitalizations and Diabetic Complications (The GOOD-ER Program)

Mark O’Connor, MD and Laurel O'Connor, MD

This study was the first of its kind to evaluate the benefits of continuous glucose monitoring (CGM) for Emergency Room patients. They analyzed whether CGM will successfully keep people from returning to the hospital with diabetes-related issues once they’ve been discharged from the ER.  Participants included people with pre-existing diabetes as well as those who arrived at the ER undiagnosed. Funded by the UMass Memorial Diabetes Center of Excellence Herman G. Berkman Diabetes Clinical Innovation Fund.

Using Smart Watch Technology to Prevent Dangerous Hypoglycemia

Mark O’Connor, MD and Stephanie Carreiro, MD

This was a pilot study of people with type 1 diabetes who were at risk for hypoglycemia. The goal is to create an optimized algorithm for detecting hypoglycemia based on smart watch data.  Funded by UMass Memorial Medical Group’s Prize for Academic Collaboration and Excellence (PACE) Award.

Breath Acetone Level as a Measure of Diabetes Control 

(H00016426) Michael Thompson, MD

This research tested a device that measures the amount of acetone in the breath.  Acetone is naturally produced when the body digests fats and carbohydrates.  It is thought that there are higher levels in people with diabetes than healthy non-diabetics.  This study investigated levels of breath acetone and compared them to blood sugar levels in people with and without diabetes. 

HYCLO (Hybrid Closed Loop Insulin Delivery System Data Collection)

(IRB00000766) Michael Thompson, MD

This project collected data over the first year of clinical use of the Medtronic MiniMed 670G closed loop insulin delivery system among patients with type 1 diabetes and evaluated how the system impacted both clinical and patient-reported outcomes.  

T1D Exchange Ancillary Study: Residual C-Peptide in Patients with Type 1 Diabetes

(H14601) David Harlan, MD

Studied how often patients with T1D still produce at least some of their own insulin and if it's related to how long they've had diabetes or their age at diagnosis.

Onset 9 

(H00013294) Samir Malkani, MD and Eyad Hamoudeh, MD

Assessed the advantage, if any, of the newly approved faster-acting Aspart (FiASP) in combination with Degludec (Tresiba) in insulin-dependent type 2 diabetes, compared to Aspart (Novolog) and Degludec (Tresiba).  

New Onset T1D Blood Samples 

(H-11522) Dale Greiner, PhD

Blood samples from newly diagnosed type 1 diabetes patients were collected within one month of diagnosis and again at four months from diagnosis. This study was in collaboration with Genzyme to produce a comprehensive RNA transcriptome during new onset T1D.

T1GER (SIMPONI to Arrest Beta Cell Loss in New Onset Type 1 Diabetes) 

(H00011321) Michael Thompson, MD

Tested whether the anti-TNF medication Golimumab can preserve beta-cell function in children and young adults with newly diagnosed type 1 diabetes.  

WISDM (Wireless Innovation for Seniors with Diabetes Mellitus) 

(IRB00000766) Michael Thompson, MD

This study was intended to determine if a continuous glucose monitor (CGM) is helpful for older adults to manage type 1 diabetes and reduce hypoglycemia.  

T1D Exchange Type 1 Diabetes Network 

(H14240) David Harlan, MD

This clinic registry contains about 25,000 individuals diagnosed with type 1 diabetes, to study and learn more about T1D.   

PERL (Trial of Allopurinol to Prevent GFR Loss in Type 1 Diabetes) 

(H00004468) Michael Thompson, MD

Designed to test whether the medication allopurinol can prevent or slow down kidney disease in people with type 1 diabetes. Participants had a history or presence of microalbuminuria or moderate macroalbuminuria, or evidence of declining kidney function.