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October/November 2021

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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 Trials

PBL | Immune Function in Autoimmune Disease - H11522

Principal Investigator: 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) - H00003107

Principal Investigator: 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 - H00018380

Principal Investigator: Silvia Corvera, PhD

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).  It's our goal to determine if these cells are different in people with type 2 diabetes as this may help explain what causes diabetes and related conditions including obesity.

Seeking volunteers 45 years and older, with or without type 2 diabetes, to give blood samples and have a fat aspiration biopsy.

Recently Closed Trials

Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes - H00010550

Principal Investigator: Benjamin Nwosu, MD

Studying the role of vitamin D supplementation on the honeymoon phase of type 1 diabetes in children who are on standardized insulin treatment.  Recent studies suggest the exciting possibility that vitamin D supplementation, a safe and easy-to-implement therapy in children, may extend partial clinical remission and increase residual beta cell function.  The overall goal is to reduce the long-term complications of type 1 diabetes.  This study is currently recruiting males and females between the ages of 10 and 21 years old with T1D who are less than 3 months from their first insulin injection.  

The Natural History Study of the Development of Type 1 Diabetes - H-12155

Led by Amy Darukhanavala, MD with pediatric nurse Emilie Cloutier

Also known as TrialNet, this network is dedicated to conducting type 1 diabetes prevention research and studying intervention therapies for children and adults with newly diagnosed T1D.  

Breath Acetone Level as a Measure of Diabetes Control - H00016426

Principal Investigator: Michael Thompson, MD

This research is testing a device that measures the amount of acetone in your breath.  Acetone is naturally produced when your body digests fats and carbohydrates.  It is thought that there are higher levels in people with diabetes than healthy non-diabetics.  This study will look at the levels of breath acetone and compare them to blood sugar levels in people with and without diabetes. You will be compensated for your time.

HYCLO (Hybrid Closed Loop Insulin Delivery System Data Collection) -IRB00000766

Principal Investigator: Michael Thompson, MD

This project collects 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 evaluates how the system impacts both clinical and patient-reported outcomes.  

T1D Exchange Ancillary Study: Residual C-Peptide in Patients with Type 1 Diabetes - H14601

Principal Investigator: David Harlan, MD

Investigates how often patients with T1D still produce at least some of their own insulin and if it is related to how long patients have had T1D or their age at diagnosis.

Onset 9 - H00013294

Led by Samir Malkani, MD and Eyad Hamoudeh, MD

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

New Onset T1D Blood Samples - H-11522

Principal Investigator: Dale Greiner, PhD

Blood samples from newly diagnosed type 1 diabetes patients were collected within one month of diagnosis and again at 4 months from diagnosis.  Working 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

Principal Investigator: Michael Thompson, MD

Testing 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

Principal Investigator: Michael Thompson, MD

This study is intended to determine if a continuous glucose monitor (CGM) is helpful for older adults to manage their type 1 diabetes and reduce hypoglycemia. Requirements: at least 60 years old, have T1D, use a pump or multiple daily injections of insulin, and have an A1c greater than 10.0%.  

T1D Exchange Type 1 Diabetes Network - H14240

Principal Investigator: David Harlan, MD

This clinic registry has 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 

Principal Investigator: Michael Thompson, MD

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