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Clinical Trials - October/November 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

Type 1 Diabetes Peer Mentor Study

The purpose of this study is to develop a questionnaire about peer mentor support for parents raising children with T1D, and youth (ages 18 – 25) who are living with T1D. Participants will simply complete a questionnaire will receive a $25 gift card as a thank you. Email diane.quinn@umassmed.edu for details.

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.

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.

Conquering Diseases Biorepository Project - H12562

Led by Katherine Ruiz De Luzuriaga, MD

Interested people living with type 1 diabetes or type 2 diabetes can click on the link above to consent to this project in order to donate a one-time blood sample to the biorepository.

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 better understand T1D and other autoimmune diseases

Diabetes Center of Excellence Potential Research Volunteer Registry - H12562

Principal Investigator: Michael Thompson, MD

Any patient type 1 (T1D) or type 2 (T2D) diabetes interested in our clinical research can consent to the registry and sign up for the UMass Medical 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

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.  

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.  

Ongoing or Recently Closed Trials

iPSC - H00003107

Principal Investigator: David Harlan, MD

Growing new beta cells from people’s own peripheral blood stem cell lines and using them to recreate and study autoimmune diabetes in our humanized mice.

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 β-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%.  

Gocap - H00011644

Principal Investigator: Michael Thompson, MD

A pilot trial testing the functionality and usefulness of the Common Sensing Gocap, a prefilled insulin pen dose tracking cap for people on a Lantus and/or Apidra insulin pen, and can use a smartphone application.

Credence - H00006240

Principal Investigator: Michael Thompson, MD

Assessing whether Canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes, 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

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.   

Get In-Touch, Livongo Health - H00004434

Principal Investigator: Michael Thompson, MD

Studying the InTouch™ Blood Glucose Monitoring System which automatically sends blood sugar results to the health care team to see how this may improve overall diabetes care.  

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.

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