Current Studies
Open to Enrollment
Trial Title: Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification (GEM).
IRB-HSR#220259
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: A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ Technology in Adults with Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP).
IRB-HSR#230140
PI: Sue Brown, MD
CRC: Jasmeen Dhillon, MS
The purpose of this study is to learn whether an automated insulin delivery (AID) system can safely improve blood sugar control for individuals with type 2 diabetes. The study AID system is made by Tandem Diabetes Care. It is called t:slim X2 with Control-IQ Technology. An AID system is sometimes referred to as an artificial pancreas or closed-loop system. The system uses a continuous glucose monitor (CGM), an insulin pump, and a software program to automatically give insulin and control blood sugar. The duration of this study is up to 17 weeks.
You may be eligible for this study if:
- You are 18 years of age or older
- You have a clinical diagnosis of type 2 diabetes for at least 6 months
- You are currently using insulin pump or taking several insulin injections a day
- You are willing to use NovoLog insulin provided by the study or another such insulin that can be used in the study AID system
- You are willing to do meal and exercise sessions at home
Some visits are completed in-person at UVA. Other visits may be completed by telephone, email, text, or videoconferencing. Study-related Hemoglobin A1c, pregnancy test, and physical exam (if one hasn’t been done in the last 12 months) provided free of charge.
Compensation for study completion is $500. If you also complete the exercise and meal tests, you will be paid an additional $50 per test, up to a maximum of $300. You may be provided Novolog at no charge during the study. You will be provided with a study insulin pump, pump supplies, and CGM supplies to use during the study.
For more information, please email: Jasmeen Dhillon
Trial Title: Adaptive Motif-Based Control (AMBC): Neural Net Implementation of Automated Insulin Delivery. Neural Net Artificial Pancreas (NAP).
IRB-HSR#230058
PI: Dr. Sue Brown, MD
CRC: Morgan Fuller, M.S.
The purpose of this study is to assess the safety of the Neural Net Implementation algorithm (complex mathematical formula) as compared to another algorithm called UVA Model Predictive Control Algorithm (UMPC) that the UVA Center for Diabetes Technology has developed. The NAP and UMPC are automated insulin delivery algorithms designed to result in similar insulin dosing decisions but use different mathematical approaches to dose insulin. Both NAP and UMPC are investigational devices.
You will be studied at a local hotel for approximately 20 hours per session. The two hotel sessions can be performed back-to-back during the same hotel stay or in two hotel stays separated up to 28 days. After study enrollment, one week of data will be downloaded from your insulin pump or from your t:connect account to establish your baseline values.
You may be eligible for this study if:
- you are 18 years of age or older
- have a clinical diagnosis of type 1 diabetes for at least 1 year
- currently using insulin for at least six months
- currently using the Tandem Control-IQ (CIQ) automated insulin delivery (AID) system
Study-related tests including pregnancy test, physical exam, and the HbA1c lab will be offered free of charge.
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.
Compensation: $500 for completing the study.
For more information, please email: Morgan Fuller
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
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: 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).
IRB-HSR#220327
PI: Dr. Chiara Fabris, Ph.D
CRC: Jasmeen Dhillon, M.S.
The University of Virginia Center for Diabetes Technology seeks adults between the ages of 18-80 who have diagnosed with type 2 diabetes for at least one year to participate in a research study. The purpose of this study is to gather data that will be used to develop a future web-based application that will help doctors take better care of people living with type 2 diabetes. This study will ask for the collection of data that is generated as a part of your normal health care. A study Dexcom G6 Continuous Glucose Monitor (CGM) will be provided to you to use during the study.
If you agree to participate, this study will involve a screening appointment and a CGM training visit, each will take about 1 hour to complete, and weekly check-in visits for four weeks. We will ask you to record some information about your insulin use and your meals, and we will also ask to collect about 30 days of data obtained from the Dexcom G6 Continuous Glucose Monitor (CGM). The hemoglobin A1c blood test, if needed, and the CGM supplies will be provided free of charge.
Study duration is approximately 30 days (6 visits total). Visits may be completed in person, telephone, or videoconferencing. Compensation up to $200 will be offered after completion of the study.
For more information, please email: Jasmeen Dhillon
Trial Title: Adaptive Behavioral Control (ABC) in a Closed-Loop System: A Randomized Crossover Clinical Trial.
IRB-HSR#220300
PI: Dr. Sue Brown, MD
CRC: Carlene Alix
The University of Virginia, Department of Diabetes Technology, seeks adults between the ages of 18-70 who have Type 1 Diabetes to participate in a clinical study.
The purpose of this study is to test a Web-Based Information Tool (WIT). This software will provide additional information regarding your hypoglycemic risk, your hyperglycemia risks, your daily glycemic profile, and may suggest potential changes to your insulin parameters. You will continue to use your Tandem insulin pump with Control-IQ Technology, and you will be trained how to use and interact with WIT.
You may be eligible for this study if:
- You were diagnosed with type 1 diabetes at least one year ago
- Currently using or anticipated to be using the t:slim X2 insulin pump with Control-IQ technology
- Currently using or willing to use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump
Participation in the study involves:
- Daily interactions with the software
- Answering questions about the software
- 14 study visits during the 26 week study; visits may be completed in person, telephone, or videoconferencing
- Questionnaires will take approximately 15-30 minutes each visit.
Study-related tests provided free of charge include hemoglobin A1c test (fingerstick), blood is drawn to check liver and kidney function (if none obtained within 6 months of screening), physical examination, and pregnancy test (if applicable). Compensation includes up to $600 for completing the study.
For more information, please email: Carlene Alix
Trial Title: Artificial Pancreas – Adolescent Physiology & Psychology Longitudinal Evaluation (AP APPLE).
IRB-HSR#19088
PI: Dr. Mark DeBoer, MD
RC: Lianna Smith
The Center for Diabetes Technology seeks adolescents who are between 11 and less than 13 years old, going through puberty, and is living with Type 1 Diabetes for a research study.
The purpose of the study is to find out if teenagers going through puberty with Type 1 Diabetes can control their diabetes better by using an Artificial Pancreas (AP) system as compared to performing their usual diabetes care.
Your child may be eligible for this study if diagnosed with type 1 diabetes for at least 1 year, using insulin for at least six months, and their A1c is 10.0% or below (tested within the last 6 weeks).
- Participation in this study will last about 2 years
- You and your child will be required to attend a screening visit. There will be about 15 clinic or phone visits. About 10 of these visits can be done from your home, but there are about 4-5 visits that will require you to come to the Clinical Research Unit (CRU) at UVA.
- You and your child will be trained on how to use the study devices, including a CGM and an insulin pump (if assigned).
- If your child currently uses multiple daily injections (MDI) to treat his/her insulin, your child may need to use a study pump during this study.
- Your child will be required to give blood and urine samples.
- Your child will be required to have his/her body composition measured three times. This test will measure the percentages of fat, bone, water and muscle in your child’s body.
- You and your child will be required to complete questionnaires about living with diabetes.
Study-related lab tests, study equipment and their associated supplies (e.g. CGM supplies, insulin pump (if assigned), and study phone) will be provided free of charge.
For more information, please email: Lianna Smith
Trial Title: Adapting Diabetes Treatment Expert Systems to Patient’s Expectations and Psychobehavioral Characteristics in Type 1 Diabetes (DSS 2).
IRB-HSR: #200007
PI: Dr. Marc Breton, Ph.D.
RC: Emma Emory, RN
The Center for Diabetes Technology seeks adults ages 18 and up with type 1 diabetes for a research study. The purpose of this study is to test different ways CGM data can be used to help manage your diabetes.
You may be eligible for this study if you have had type 1 diabetes for at least one year and using insulin for at least one year, and your A1c is between 6.0% – 11%.
This study involves using a Dexcom G6 sensors, and an investigational diabetes application on an Android smart phone. Participants currently using multiple daily injections (MDI) may use a study insulin pump, if desired. There will be weekly surveys to complete, as well as 3 separate blood draws for A1c and lab values. This study will last approximately 7 months and there will be approximately 7 visits. These visits can be completed virtually using a web-based video conferencing tool.
Study-related Dexcom G6 sensors, transmitters, and infusion sets if applicable will be provided free of charge. Compensation of $1,000.00 will be provided for completing the study.
For more information, please email: Emma Emory
Trial Title: A Phase I/II, Open-Arm Study Evaluating the Safety of Islet Transplant on Patients with Type 1 Diabetes.
IRB-HSR: #170020
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
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- 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