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Clinical Trials Overview, June/July 2018

 

 

 

 

 

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.

Open, Accruing Trials

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

  • This project is designed to collect 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 to evaluate how the system impacts both clinical and patient-reported outcomes.

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

  • PI – Dr. Thompson

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

  • This project is designed to study 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 lengthen PCR and increase residual beta cell function (RBCF). The overall goal is to reduce the long-term complications of type 1 diabetes.
  • T1D duration of <3 months (i.e., from first insulin injection), males and females between the ages of 10 and 21 years old are currently being recruited

  • PI – Dr. Nwosu

New Onset T1D Blood Samples - H-11522

  • 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.

  • PI – Dr. Greiner

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

  • Also known as TrialNet – A network dedicated to conducting diabetes prevention research and studying intervention therapies for children and adults with newly diagnosed Type 1 Diabetes.

  • PI – Dr. Darukhanavala (Nurse – Kim Johnson)

PBL (Immune Function in Autoimmune Disease) - H11522

  • 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.

  • PI – Dr. Greiner

DCOE Potential Research Volunteer Registry - H12562

  • Any patient (T1D or T2D) interested in research can consent to the registry and sign up for a monthly research newsletter (those who express interest in Diabetes/Endocrine System Research can complete a short survey on their background and relation to diabetes).

  • PI – Dr. Thompson

Conquering Diseases Biorepository Project - H12562

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

  • PI – Dr. Ruiz De Luzuriaga

Ongoing or Recently Closed Trials

Onset 9 - H00013294

  • The 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 Type 2 Diabetes on basal-bolus insulin (with or without Metformin) with an A1c > 7.0% at baseline; Exclusion Criteria: Patients who are on DPP4 inhibitors, GLP1 analogs, or SGLT2 inhibitors.
  • PIs – Dr. Malkani and Dr. Hamoudeh

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

  • A study 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 Type 1 Diabetes in the past 100 days.
  • PI – Dr. Thompson

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

  • A study designed to find out if a CGM or continuous glucose monitor is helpful for older adults to manage their Type 1 Diabetes and reduce hypoglycemia.
  • Patients must be between at least 60 years old, have T1D, use a pump or multiple daily injections of insulin, and have an HbA1c<10.0%.  Patients are not eligible if they have used a CGM at home in the last 3 months.
  • PI – Dr. Thompson

Gocap - H00011644

  • The Gocap trial 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.
  • PI – Dr. Thompson

Credence - H00006240

  • 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.
  • PI – Dr. Thompson

T1D Exchange Type 1 Diabetes Network - H14240

  • Clinic registry of about ~25,000 individuals diagnosed with T1D to learn more about T1D.
    Any pediatric/adult patient diagnosed with T1D is eligible to enroll in the T1D Exchange network.
  • PI – Dr. Harlan

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

  • 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.
  • PI – Dr. Harlan

Get In-Touch, Livongo Health - H00004434

  • 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.
  • PI – Dr. Thompson 

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

  • A study designed to test whether the medication allopurinol can prevent or slow down kidney disease in people with Type 1 Diabetes.
    Eligible patients have history or presence of microalbuminuria or moderate macroalbuminuria, or evidence of declining kidney function.
  • PI – Dr. Thompson 

iPSC - H00003107

  • 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 investigate to recreate and study autoimmune diabetes in the humanized mouse.
  • PI – Dr. Harlan

 

 

 

 

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