Diabetes Clinical Trials

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 for individuals with diabetes.

For information concerning any of these clinical trials, please contact the Clinical Trials Unit at: 508-856-2800

Type 1 diabetes trials

The natural history study of the development of type 1 diabetes 
Purpose: The Natural History Study of the Development of Type 1 Diabetes will study people at increased risk for type 1 diabetes to learn more about how type 1 diabetes occurs.
Principal Investigator (UMass): Mary M. Lee, MD

Oral Insulin for Prevention of Diabetes in Relatives At Risk for Type 1 Diabetes Mellitus
Purpose: The purpose of this study is to examine if oral insulin will help delay or prevent Type 1 diabetes in those at risk for the disease.
Principal Investigator (UMass): Mary M. Lee, MD

Parents' Education Through Simulation for Diabetes (PETS-D)
Purpose: This study will examine if parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have significantly higher diabetes knowledge (cognitive visual schemata), better technical and problem-solving competence and confidence, and lower fear and stress/anxiety levels; and provide better diabetes management at 14 weeks compared to those parents receiving standard diabetes education.
Principal Investigator: Susan Sullivan-Bolyai, DNSC, CNS, RN

The T1D Exchange Type 1 Diabetes Network
Purpose: The T1D Exchange is a registry of ≈25,000 individuals diagnosed with T1D.  The intent is that for properly consented individuals, standard clinical data is captured to allow study investigators address questions like,

  • What clinical characteristics predict which individuals avoid diabetes complications?
  • How often do individuals with T1D experience severe hypoglycemia.

In addition, individuals enrolled in the T1D Exchange can be made aware of clinical trials for which they may be eligible.   
Principal Investigator (UMass): David M. Harlan, MD

T1D Exchange Ancillary Study: Residual C-Peptide in Patients with Type 1 Diabetes
Purpose: It has long been known that many individuals with even long standing T1D still make small amounts of insulin (and C-peptide is a simple measure that allows scientists to determine how much of the measured circulating insulin came from that individual's pancreas, as opposed to injected insulin).  The purpose of this study is to identify patient characteristics (if possible) that associate with prolonged pancreas insulin production, in the hope that might offer clues to preserve or promote an individual's pancreatic insulin producing capacity. 
Principal Investigator (UMass): David M. Harlan, MD

T1D Exchange: Severe Hypoglycemia in Older Adults with Type 1 Diabetes
Purpose: One of the most difficult challenges faced by individuals with T1D striving to achieve near-normal blood glucose control is that such intensive efforts have been shown to increase the risk for severe low blood glucose episodes. This study is designed to assess the frequency of such low blood glucose episodes, and determine (if possible) patient characteristics that may predispose an individual to severe hypoglycemia.  The ultimate goal is to develop strategies to minimize hypoglycemia.  
Principal Investigator (UMass): John P. Lock, MD

Development of an innovative diabetes education program: A focus group analysis of adolescents with type 1 diabetes mellitus and their parents
Principal Investigator: Susan Sullivan-Bolyai, DNSC, CNS, RN

Impact of pet ownership on glycemic control in youth with Type 1 Diabetes
Purpose: The investigators' long-term goal is to discover novel, inexpensive and feasible strategies to improve the management and well-being of youth with T1DM. The specific objective of this proposal is to quantify the impact of responsible pet ownership on the glycemic control and health related quality of life in youth with T1DM.
Principal Investigator (UMass): Louise Maranda, PhD

A Phase III, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical Efficacy and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects, Andromeda Protocol Number 1001
Purpose: The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression. There is an open-label and long term safety study.
Principal Investigator (UMass): John P. Lock, MD

BEGIN™: A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents with Type 1 Diabetes Mellitus:  A 26 week, Multinational, Multi-center, Open-labeled, randomized, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to less than 18 years with Type 1 Diabetes Mellitus on a Basal-Bolus Regimen with Insulin Aspart as Bolus Insulin.
Principal Investigator (UMass): Leslie Soyka, MD

A Comparative Assessment of the Efficacy of Hemoglobin A1c Reduction by Insulin Pump Therapy vs. Adjunctive Metformin Therapy in Type 1 Diabetes
Principal Investigator (UMass): Benjamin U. Nwosu, MD

Molecular-Genetic Mechanisms of neuropsychiatric, developmental, and metabolic diseases
Principal Investigator: Evgeny Rogaev, PhD

A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
The purpose of this research is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitus.
Principal Investigator (UMass): Leslie A. Soyka, MD

LIFT: Long-Term investigative Follow up
Purpose: This is a descriptive study to evaluate the long term effects of participation in TrialNet studies; for subjects that participated in TrialNet and have developed Type 1 Diabetes.
Principal Investigator: Leslie A. Soyka, MD

Simkid: Teaching Parents of Newly Diagnosed Young Children with Type 1 Diabetes Management with a High Fidelity (Robotic) Patient Simulator (FNINR)
A study to explore through a focus group with experienced parents of young children with type 1 diabetes the use of a high fidelity (robotic) patient simulator (Simkid) as a supplement to the didactic and role modeling parent education that occurs during the early days after diagnosis.
Principal Investigators: Susan Sullivan-Bolyai, DNSC, CNS, RN and Mary M. Lee, MD

Type 1 diabetes and Type 2 diabetes trials

UMass Memorial Cares-Conquering Diseases Research Volunteer Database Project
UMass Memorial Cares-Conquering Diseases Biorepository Project
Purpose: The Conquering Diseases Biorepository is a partnership between the patients being cared for by the health professionals of UMass Memorial, and the research community at the University of Massachusetts Medical School. The project will make available to researchers high quality patient specimens. The ultimate goal of the Biorepository is to gain a better understand the diseases our patients suffer from, how to prevent, and better treat these afflictions.
Principal Investigator: Craig M. Lilly, MD

Testing the PhotoGlucometer, a thermo-optic device for measuring of blood glucose concentration without a blood sample
Principal Investigator: John Mordes, MD

Testing the Grove Blood Glucose Meter, a device for measuring blood glucose concentration in vivo without a blood sample
Principal Investigator: John Mordes, MD

Testing the PhotoGlucometer2, an optical device for measuring of blood glucose concentration without a blood sample
Principal Investigator: John Mordes, MD

Sulfonylureas and Risk of Falls and Fractures in Nursing Homes
Principal Investigator: Kate L. Lapane, PhD

Improving Knowledge About the Risk to Benefit Ratio for Medications Used by Medicaid/Medicare Recipients
Principal Investigator: Kate L. Lapane, PhD

Glycemic Control in Children and Adolescents with Double Diabetes: Trial of Optimized Insulin-Metformin Regimen
Purpose: The significance of this project is to investigate the effects of adjunctive metformin therapy in children and adolescents with double diabetes. Double diabetes describes a clinical state where an individual possesses features of both type 1 and type 2 diabetes. There is a paucity of data on the role of adjunctive metformin therapy in children and adolescents with double diabetes. To help fill this knowledge gap, the investigators propose a randomized, double-blind, placebo-controlled trial of metformin in double diabetes. Specifically, the investigators will evaluate changes in hemoglobin A1c and anthropometry in patients with a diagnosis of type 1 diabetes who also have features of type 2 diabetes or metabolic syndrome as well as patients with type 2 diabetes who possess diabetes-associated autoantibodies. This will help determine the safety profile, and efficacy of adjunctive metformin therapy in these subjects.
Principal Investigator: Benjamin U. Nwosu, MD

Outcomes of nonmydriatic retinal photography for diabetic retinopathy screening in individuals who have not had recommended eye examinations- a chart review
Principal Investigator: Samir Malkani, MD

Type 2 diabetes trials

Impact of Bariatric Surgery on Glucose Levels in Patients with Diabetes, Type II
Principal Investigator: Thomas M. English, PhD

Outcomes of bariatric surgery (UMMMC Bariatric Surgery Registry)
Purpose: The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular disease.
Principal Investigator: Richard A. Perugini, MD

Use of Medicare Data to Augment Data Collection efforts of the Long Life Family Study (LLFS) and to Determine the Exceptionality of LLFS Subjects Compared to a Random Medicare Enrollee Sample
Principal Investigator: Arlene S. Ash, PhD

An Exploratory Qualitative Study of Persons with Diabetes Who Have Low Literacy and Good Glucose Control
Principal Investigator: Anthony Valdini, MD

Treatment Options for Type 2 Diabetes in Adolescents and Youth 2
Principal Investigator: Amanda Angelescu, MD

Self Care Management: Patient Centered Diabetic Wound Care Using Smart Phones
Principal Investigator: Ronald Ignotz, PhD

A Trial Comparing the Efficacy, Patient-Reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects with Type 2 Diabetes Mellitus Requiring High-Dose Insulin
Principal Investigator: John P. Lock, MD

Human Adipose Tissue Stem Cells and Metabolic Disease (HATSC)
Principal Investigator: Silvia Corvera, MD

Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycemic control in children and adolescents with type 2 diabetes; a 26-week double-blind, randomized, parallel group, placebo controlled multi-center trial followed by a 26-week open-label extension
Purpose: This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.
Principal Investigator (UMass): Leslie A, Soyka, MD

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Metformin and/or Sulfonylurea Anti-Diabetes Agents
Purpose: To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes.
Principal Investigator (UMass): John J. Kelly, MD

StoryGuides: Making Comparative Effectiveness Useful for Vulnerable Populations
Principal Investigator: Jeroan Allison, MD

Patient Navigator Evaluation
Principal Investigator: Milagros Rosal, PhD, MD

Hepatic Dysfunction, Vitamin D Status, and Glycemic Control in Diabetes
Purpose: This study for children and adolescents with Type 2 diabetes is to investigate the relationships between NAFLD, vitamin D status, and glycemic control in patients with T2D.
Principal Investigator: Benjamin U. Nwosu, MD