Current Studies

Trial Title: Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification (GEM).
IRB-HSR#220259
NCT05766735
University of Virginia PI: Daniel Cox, PhD
Colorado University PI: Tamara Oser, MD
CRC: Corey Rynders, PhD

The University of Virginia, Center for Diabetes Technology, seeks adults between the ages of 30-80 who have Type 2 Diabetes to participate in a clinical study. The purpose of this study is to find out if people who are newly diagnosed with Type 2 Diabetes respond better to regular routine care or routine care paired with a lifestyle intervention that focuses on reducing how much blood glucose goes up after eating, by avoiding certain foods and increasing routine physical activity.

You may be eligible for this study if:

• You were diagnosed with Type 2 Diabetes within the past 12 months
• You are not currently using a diet program or medication to manage your Type 2 Diabetes

The study involves:

• The study duration is 13 ½ months
• There are up to 7 visits in this study
• There are 3 visits will be in person at the University of Virginia – at the start of the study, after 4 ½ months and after 13 ½ months. These visits will be about 3 ½ hours in length.
• At these visits,
  • You will have a physical examination
  • Your blood will be drawn to check liver function and your hemoglobin A1c
  • You will be asked to electronically complete questionnaires will take less than an hour to complete

Study-related exams or tests include (provided free of charge):

• Blood test
• Physical examination
• Interviews with study team
• Questionnaires to complete
• Dexcom G7 Continuous Glucose Monitoring supplies will be provided at different times in the study

Compensation: Up to $300 to complete the study

For more information, please email: Corey Rynders

Trial Title: Short Use of Automated Insulin Delivery (AID-BIT) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study.
IRB-HSR#230316
NCT06024928
PI: Anas El Fathi, PhD
MD: Dr. Ralf Nass
CRC: Lianna Smith

Setting basal insulin parameters typically takes several weeks and requires frequent calls with your treating physician. The purpose of this study is to see if using an insulin pump could assist, and potentially accelerate, identifying the correct basal rates for you to better manage your type 2 diabetes. This is a randomized study so you will not get to choose which group you are assigned to. Some people enrolled in the study will use an insulin pump to adjust their insulin basal rates, and other people will contact the study physician to adjust their insulin basal rates. Both groups will wear a continuous glucose monitor (CGM) during the study. A CGM measures your blood glucose values every 5 minutes and provides you with a real-time look at your blood glucose readings.

You may be eligible for this study if:

• you are 18 years of age or older
• have a clinical diagnosis of type 2 diabetes for at least 1 year
• currently using an approved long-acting insulin for at least six months (e.g., insulin glargine, insulin degludec)

Study related supplies will be provided to you at no cost (e.g., insulin pump and its supplies, CGM supplies, blood glucometer and strips, ketone meter and strips, etc.).

Compensation up to $200 will be offered for completing the study. If an in-person visit at UVA is necessary during the study, a one-time payment of $100 to pay for gas and mileage will be provided. The study will take about 30 days to complete the study.

We want to assure you that we will keep your information confidential. You do not have to be in this study if you do not want to participate. Your decision to be in any study is totally voluntary. Your care at UVA will not be altered by your decision to participate or not participate.

For more information, please email: Lianna Smith

Trial Title: Sex Differences In Glucose Control and Diabetes Management.
IRB-SBS: #6021
PI: Chiara Fabris, PhD

The purpose of this study is to highlight differences between female and male in diabetes management and gather evidence on extra difficulties that female may experience – for example in relation to menstrual cycle and menopause. Results from this study will inform on the need to develop technological solutions to better support diabetes management in the female population. The survey will take about 10 minutes to complete, and responses will be anonymous.

Trial Title: Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes (AP-CVD).
IRB-HSR#220180
NCT05653518
PI: Dr. W. Benjamin Horton, MD
CRC: Lee Hartline

This study will examine cardiovascular effects to your heart while using the artificial pancreas (AP) technology. The AP technology is a system of devices that closely mimics the glucose regulating function of a healthy pancreas. It includes an insulin pump and a continuous glucose monitor (CGM). In this study, we will use the Food and Drug Administration (FDA) approved Tandem t:slim insulin pump with Control-IQ Technology and the FDA approved Dexcom G6 CGM. This study will research if the changes in your blood glucose levels will be reduced and, therefore, reduce some of the cardiovascular biomarkers that represent harmful effects while using the AP. A biomarker is a biological molecule found in blood.  

The University of Virginia Center for Diabetes Technology is seeking adults 18-40 years old diagnosed with type 1 diabetes for a research study. The purpose of this study is to examine the cardiovascular effects while using the artificial pancreas (AP) technology.  

If you participate in this study: 

• you may be asked to wear a Tandem t:slim insulin pump with Control-IQ Technology and a CGM for up to 13 weeks or you will be asked to wear only a CGM for 13 weeks.   
• you will be asked to provide blood samples taken to measure your heart functioning at five different time points in the study. These blood draws will take about 15 minutes to complete.  
• You will be asked to complete cardiac testing at two different times in the study. This testing will take less than an hour to complete.  

 The blood samples, cardiac testing, insulin pump supplies and CGM supplies are provided at no-cost. You will need to provide your own insulin. Compensation: $725.00 for study completion 

For more information, please email: Lee Hartline

Trial Title: A Phase I/II, Open-Arm Study Evaluating the Safety of Islet Transplant on Patients with Type 1 Diabetes.
IRB-HSR: #170020
NCT03698396
PI: Dr. Kenneth Brayman
RC: Robin Kelly, RN

The UVA Transplant Surgery Division seeks adults ages 18 to 70 with Type 1 Diabetes and severe hypoglycemic unawareness for a research study.

The purpose of the study is to determine if islet transplantation will help with glucose stabilization in type 1 diabetics.

• This study involves an islet cell transplant procedure in interventional radiology with inpatient stay to stabilize glucose. It includes follow-up with 29 study visits over 1 year after the transplant.
• Study-related exams, tests and medication provided free of charge.
• No compensation is provided for this study.

For more information, please email: Robin Kelly

• An Exploratory 16-Week Pilot Study Of The Effect And Safety Of A Novel CGM-Based Titration Algorithm For Basal Insulin, With Or Without Non-Insulin Anti-diabetic Drugs In T2DM Participants Treated With Basal Insulin (CGM-DTx Degludec).
• A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ Technology in Adults with Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP).
• The Pediatric Artificial Pancreas Automated Initialization trial (PEDAP-AI): A Pilot Study of AI Advisor-Driven Pump Initiation and Parameter Adaption in Young Children with type 1 Diabetes.
• Adaptive Behavioral Control (ABC) in a Closed-Loop System: A Randomized Crossover Clinical Trial.
• Artificial Pancreas – Adolescent Physiology & Psychology Longitudinal Evaluation (AP APPLE).
• Adapting Diabetes Treatment Expert Systems to Patient’s Expectations and Psychobehavioral Characteristics in  Type 1 Diabetes (DSS2).
• Algorithmic Development, Prototyping, and Pilot Clinical Testing of a Therapy Optimization Platform to Support Healthcare Providers in the Management of Type 2 Diabetes Preliminary Data Collection (DSS-HCP-T2).
• Adaptive Motif-Based Control (AMBC): Neural Net Implementation of Automated Insulin Delivery. Neural Net Artificial Pancreas (NAP).
• CloudConnect – International Diabetes Closed-Loop (iDCL) Trial, Clinical Acceptance of the Artificial Pancreas
• Project Nightlight – Web-Based Simulation Tool for Self-Management Support in Type 1 Diabetes Mellitus
• Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth with Type 1 Diabetes: The AP Ski Camp Continued
• Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp
• Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
• At Home Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAs) System and Run-to-Run Adaptation
• SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus
• Insulin- Glucose-Glucagon Network: Defining a Type 1 Diabetes Progression Index
• The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
• A Study of t:Slim X2 With Control-IQ Technology (DCLP5)
• Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
• Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
• Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes
• CGM Use in Islet Transplant Recipients
• Exercise Activity-Based Bolus Decisions
• Enhancement of Glucagon Counterregulation in Type 1 Diabetes by Basal Amylin Replacement
• Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
• USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
• Dual Hormone