Clinical Trials - June 2019

Ongoing clinical trials in diabetes at The University of Massachusetts Memorial Medical Center, The University of Massachusetts Children's Medical Center and the University of Massachusetts Medical School are focused on testing new treatment approaches designed to improve the quality of life of patients with diabetes.  

Register for a trial or learn more: 

Contact Erek at (774) 443-7137  or  Erek.Arsiniega@umassmed.edu

Open, Accruing Trials

DCOE Potential Research Volunteer Registry - H12562

Dr. Thompson

Any patient type 1 (T1D) or type 2 T2D) interested in our clinical research can consent to the registry and sign up for a monthly research newsletter.  Download the enrollment form and check the Diabetes/Endocrine System box.  

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

Dr. Darukhanavala with pediatric nurse Kim Johnson

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.  

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

Dr. Nwosu

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.  Currently recruiting males and females between the ages of 10 and 21 years old with T1D for less than 3 months from their first insulin injection.  

Breath Acetone Level as a Measure of Diabetes Control - H00016426

Dr. Thompson

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.

Group 1: (One 1-hour study visit) Adults 18 years and older, non-smoker, with or without diabetes, blood test and breath test.

Group 2: (Screening visit and one 5-hour study visit) Adults with type 2 diabetes, non-smoker, oral glucose tolerance test with blood and breath tests.

PBL (Immune Function in Autoimmune Disease) - H11522

Dr. Greiner

We are always looking for volunteers with autoimmune diseases (such as type 1 diabetes, vitiligo, psoriasis, ulcerative colitis, etc.) and normal controls to give blood samples to support our bench research efforts. 

Conquering Diseases Biorepository Project - H12562

Dr. Ruiz De Luzuriaga

Interested T1D or T2D patients can click on the link above to consent to this project in order to donate a one-time blood sample to the biorepository.

Ongoing or Recently Closed Trials

iPSC - H00003107

Dr. Harlan

The purpose of this study is to grow new beta cells from the patient’s own peripheral blood stem cell lines and use them to recreate and study autoimmune diabetes in our humanized mice.

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

Dr. Thompson

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.  Eligible patients must be clinically diagnosed with T1D and planning to initiate use of the 670G system as part of usual care

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

Dr. Harlan

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

Dr. Malkani and Dr. Hamoudeh

This study aims to 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).  Inclusion Criteria: Individuals with T2D on basal-bolus insulin (with or without Metformin) with an A1c greater than 7.0% at baseline; Exclusion Criteria: Patients who are on DPP4 inhibitors, GLP1 analogs, or SGLT2 inhibitors.

New Onset T1D Blood Samples - H-11522

Dr. Greiner

Blood sample from newly diagnosed T1D pediatric/adult patients will be collected within 1 month of diagnosis and at the 4 month from diagnosis time-point.  In collaboration with Genzyme to produce a comprehensive RNA transcriptome during new onset T1D.

T1GER (SIMPONI to Arrest β-cell Loss in New Onset Type 1 Diabetes) - H00011321

Dr. Thompson

This study is designed to test whether the anti-TNF medication Golimumab can preserve beta-cell function in children and young adults with newly diagnosed type 1 diabetes.  Patients must be between the ages of 6 and 21, and have been newly diagnosed with T1D within the past 100 days.

WISDM (Wireless Innovation for Seniors with Diabetes Mellitus) - IRB00000766

Dr. Thompson

This study is designed to find out if a continuous glucose monitor (CGM) is helpful for older adults to manage their T1D and reduce hypoglycemia.  Patients must be at least 60 years old, have T1D, use a pump or multiple daily injections of insulin, and have an A1c greater than 10.0%.  Patients are not eligible if they have used a CGM at home in the last 3 months.

Gocap - H00011644

Dr. Thompson

This is a pilot trial testing the functionality and usefulness of the Common Sensing Gocap, a prefilled insulin pen dose tracking cap.  Patients must be on a Lantus and/or Apidra insulin pen, and can use a smartphone application.

Credence - H00006240

Dr. Thompson

The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with T2D, Stage 2 or 3 CKD and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an ACEi or ARB.

T1D Exchange Type 1 Diabetes Network - H14240

Dr. Harlan

This clinic registry has about 25,000 individuals diagnosed with T1D, to study and learn more about T1D.  Any pediatric/adult patient diagnosed with T1D is eligible to enroll in the T1D Exchange network.

Get In-Touch, Livongo Health - H00004434

Dr. Thompson 

A study of a blood glucose meter (InTouch™ Blood Glucose Monitoring System) that automatically sends blood sugar results to the health care team to see how this may improve overall diabetes care.  Due back in 3 month intervals for a venous HbA1c draw and/or survey.

PERL (trial of allopurinol to prevent GFR loss in type 1 diabetes) - H00004468 

Dr. Thompson 

A study designed to test whether the medication allopurinol can prevent or slow down kidney disease in people with T1D.  Eligible patients have history or presence of microalbuminuria or moderate macroalbuminuria, or evidence of declining kidney function.