Research

Dr. Rodica Pop-Busui

Dr. Rodica Pop-Busui has concentrated her scholarship and research efforts on translational and clinical research focused on understanding the mechanisms underlying the development of diabetes and prediabetes complications. The design and execution of her clinical trials are used to test novel therapies that target mechanisms for preventing chronic complications in patients with type 1 and type 2 diabetes. As a result of her efforts, Dr. Pop-Busui's research has been funded by divisions of the U.S. National Institutes of Health (NIH), such as the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), as well as the Juvenile Diabetes Research Foundation (JDRF), Centers for Disease Control and Prevention (CDC), private foundations, and industries.

Current Clinical Trials & Studies

Dr. Rodica Pop-Busui with patient

The Pop-Busui research team is actively involved in many studies and trials in patients with diabetes and diabetic complications, as well as novel technologies for improving diabetes care, in various stages of completion. Below are examples of a broad spectrum of clinical trials evaluating novel therapies and technologies for people with diabetes for which we are still recruiting patients. If you, or someone you know, would like to see if they are eligible to participate, please select the study title below to get more information.

There are many steps to doing research including writing the proposal; applying for funding; getting approval for the study methods; recruiting, screening, and treating groups of patients; collecting the lab results; analyzing the data; and writing the findings for publication. The below studies are in various stages of this process and may not be recruiting new participants at this time.

Upcoming Trials & Studies

JDRF Center of Excellence - Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes - This is a center grant focusing on patients with type 1 diabetes (T1D) to comprehensively study and understand risk factors and protective mechanisms for diabetes chronic complications; susceptibility to hypoglycemia and improvement with the use of advanced diabetes technologies; the heterogeneity in the risk of chronic complications; and minimize the psychosocial impact of type 1 diabetes. Information: Jacob Reiss at jereiss@med.umich.edu or (734) 763-0177.

Ongoing Trials & Studies – Recruiting

TEWL - Trans-Epidermal Water Loss as a Predictive Marker for Diabetic Foot Ulcer Recurrence - This is a multi-center study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Participants will be enrolled after closure of their DFU. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site. Information: Aaron Burant at aburant@med.umich.edu, (734) 615-0552 or Jacob Reiss at jereiss@med.umich.edu, (734) 615-0552.

TINSAL - Targeting Inflammation with Salsalate in Type 1 Diabetes Neuropathy - This phase III, multi-site, randomized, double-blind, placebo-controlled clinical trial examines whether a 12-month course of the drug salsalate will prevent the progression of diabetic neuropathy in subjects with type 1 diabetes and mild diabetic neuropathy. Information: Jacob Reiss at jereiss@med.umich.edu or (734) 763-0177. View study on U-M Health Research.

Evaluation of Cardiovascular Outcomes with Semaglutide in Patients with Prior MI/Stroke/Symptomatic PAD and Overweight or Obesity - The objective of this study is to investigate the long-term effects of semaglutide in patients who are overweight or obese. Information: Cynthia Plunkett at cplunket@umich.edu or 734-936-8065.

Ongoing Trials & Studies – Not Recruiting

Multi-Center Trial in Adult and Pediatric Patients with Type 1 Diabetes Using Hybrid Closed Loop System at Home (CEP 304)
The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting for 12 months. The study enrolled patients from a wide range of ages, from 2-80 years old. 

Safety and Effectiveness Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Adult and Adolescent Subjects with Type 1 Diabetes (CIP 321)
The objective of this study is to investigate the advanced hybrid closed loop system in adult and adolescent patients with type 1 diabetes.

EDIC - The Epidemiology of Diabetes Interventions and Complications
This observational study examines the risk factors associated with the long-term complications of type 1 diabetes. The study began in 1994 and follows the 1,441 participants previously enrolled in the Diabetes Control and Complications Trial (DCCT).

Published Outcomes from Recent Trials & Studies

PERL - Preventing Early Renal Loss in Type 1 Diabetics - The PERL trial tested whether a known drug for gout - allopurinol - slows or prevents kidney disease in patients with type 1 diabetes. The trial found that reducing levels of uric acid in the blood does not guard against complication in patients with type 1 diabetes. Read more: “Serum Urate Lowering with Allopurinol and Kidney Function in Type 1 Diabetes”. NEJM, 2020. PMID: 32579810.

Wireless Innovation for Seniors with Diabetes Mellitus (WISDM). The primary objective of the trial was to determine if continuous glucose monitoring (CGM) can reduce hypoglycemia and improve quality of life in older adults with type 1 diabetes. The trial showed that the use of CGM reduces serious levels of hypoglycemia (low blood sugar), compared with standard monitoring by daily use of blood glucose finger-stick test strips. In addition, CGM users saw significant reductions in the amount of time spent in hypoglycemia and in the occurrence of severe hypoglycemic events while also improving their hemoglobin A1C levels and overall glucose control. Read more: “Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults with Type 1 Diabetes: A Randomized Clinical Trial”. JAMA, 2020. PMID: 32543682.

Bydureon in Type 1 Diabetes - This phase II trial examined the effects of the drug exenatide (Bydureon), a drug approved to treat high blood sugar in patients with type 2 diabetes, on measures of glucose control in patients with type 1 diabetes. Read more: Exenatide Extended Release in Patients With Type 1 Diabetes With and Without Residual Insulin Production”. Diabetes, Obesity and Metabolism, 2020. PMID: 32573927.
 

View more of Dr. Pop-Busui’s publications.

Ongoing Trials & Studies – Recruiting

TEWL - Trans-Epidermal Water Loss as a Predictive Marker for Diabetic Foot Ulcer Recurrence - This is a multi-center study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Participants will be enrolled after closure of their DFU. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site. Information: Aaron Burant at aburant@med.umich.edu, (734) 615-0552 or Jacob Reiss at jereiss@med.umich.edu, (734) 615-0552.

Evaluation of Cardiovascular Outcomes with Semaglutide in Patients with Prior MI/Stroke/Symptomatic PAD and Overweight or Obesity - The objective of this study is to investigate the long-term effects of semaglutide in patients who are overweight or obese. Information: Cynthia Plunkett at cplunket@umich.edu or 734-936-8065.

Long-Term Effects of Semaglutide on Diabetic Retinopathy in Subjects with Type 2 Diabetes (FOCUS), Trial Phase 3b - The objective of FOCUS is to investigate the safety of semaglutide on retinal complications in patients with type 2 diabetes. Information: Cynthia Plunkett at cplunket@umich.edu or 734-936-8065.

Ongoing Trials & Studies – Not Recruiting

Glycemia Reduction Approaches for Diabetes: A Comparative Effectiveness Study
This is a large comparative effectiveness trial evaluating the effects on four of the most widely used diabetes drugs in combination with metformin in maintaining glucose control and prevent complications in people with type 2 diabetes. Michigan Medicine recruited over 160 participants out of more than 5,000 nationwide. The trial is expected to conclude in 2021.

Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT)
The primary scientific aim of the PROMINENT study is to assess whether treatment with the selective peroxisome proliferator activated receptor modulator alpha (SPPARM-α), pemafibrate, will prevent myocardial infarction (MI), ischemic stroke, unstable angina requiring unplanned revascularization, and cardiovascular (CV) death in adults with type 2 diabetes (T2D) who have elevated triglycerides (TG) and low high-density lipoprotein cholesterol (HDL-C) levels and are at high risk for future CV events.

MOBILE - Continuous Glucose Monitoring in T2D Basal Insulin Users
This study compares the glycemic and quality of life benefits of diabetes management using the Dexcom G6 continuous glucose monitoring versus self-monitored blood glucose made by study participants and their primary care physicians. Decisions will be based on insights from real-time use and retrospective insights, determined during remote visits.

Published Outcomes from Recent Trials & Studies

Evaluation of Exenatide in Patients with Diabetic Neuropathy - This trial evaluated whether exenatide, a medication that is used to treat high blood sugar, may reverse signs and symptoms of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate diabetic peripheral neuropathy. Read more: Effects of Exenatide on Measures of Diabetic Neuropathy in Subjects with Type 2 Diabetes: Results From an 18-month Proof-Of-Concept Open-Label Randomized Study. Journal of Diabetic Complications, 2015. PMID 26264399.

GRADE - Glycemia Reduction Approaches for Diabetes: A Comparative Effectiveness Study - This is a large comparative effectiveness trial evaluating the effects on four of the most widely used diabetes drugs in combination with metformin in maintaining glucose control and prevent complications in people with type 2 diabetes. Michigan Medicine recruited over 160 participants out of more than 5,000 nationwide. The trial is expected to conclude in 2021. Dr Pop-Busui led a group of GRADE investigators in analyzing the prevalence of diabetes chronic complications in this large cohort. Read more: Prevalence of Microvascular and Macrovascular Disease in the Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) Study Cohort”. Diabetes Research and Clinical Practice, 2020. PMID: 32450102

 

View more of Dr. Pop-Busui’s publications.

Dr. Pop-Busui has participated in some of the most important diabetes studies to date, the results of which have changed the ways in which diabetes is managed around the world. Many of the studies were funded by the U.S. National Institutes of Health (NIH), as well as other top diabetes research organizations such as the Juvenile Diabetes Research Foundation (JDRF).
 

Closed Research Studies & Trials

View Dr. Pop-Busui’s CV for a complete list of her grants and research projects.