Current Studies

Trial Title: Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers (TREAT2D).
IRB-HSR#302621
NCT07063420
PI/MD: Daniel Chernavvsky, MD
CRC: Carlene Alix

The Center for Diabetes Technology is seeking adults, ages 18 and older with type 2 diabetes for a research study. The purpose of the study is to see if a new computer formula can safely help improve blood sugar levels in people with type 2 diabetes. We want to find out if using this tool works well and is safe to use.

You may be eligible for this study if: you have type 2 diabetes, are 18 years old or older, and take insulin as well as other diabetes medications.

If you agree to participate, this study will involve you using your personal insulin pen and wearing a study-provided continuous glucose monitor (CGM) for about 5 months. The study will cover the cost of the CGMs during participation. There are about 14 study visits over the course of the study. All visits may be completed remotely or in-person. Study-related exams may include a hemoglobin A1c test and lab work. The study-related exams and the study supplies are provided at no cost.

Compensation: $200

For more information, please email: Carlene Alix

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: Chiara Fabris, PhD
Colorado University PI: Tamara Oser, MD
CRC: Jacqueline Rodriguez

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: Jacqueline Rodriguez

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: A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET at Home).
IRB-HSR#302656
NCT07039617
PI/MD: Sue Brown, MD
CRC: Lianna Smith

The Center for Diabetes Technology seeks adults ages 18 and older with Type 1 Diabetes for a research study. The purpose of this study is to find out if a system called AIDANET (Automated Insulin Delivery Adaptive NETwork) is safe and can help control blood sugar better for people with Type 1 Diabetes. The study involves you to wear the study equipment to manage your diabetes for 4 months. There will be 17 study visits with most of the visits completed by telephone or virtually from home. You may need to attend an in-person training visit to learn how to use the Tandem Mobi insulin pump, a Dexcom continuous glucose monitor (CGM), and the investigational AIDANET system. Study-related equipment and supplies are provided at no cost to you. You will need to use your own insulin.

Compensation: $500 to complete the study and reimbursement of $100 for clinic visits at UVA (maximum of 3 trips = $300)

For more information, please contact the study coordinator, Lianna Smith at lhs7px@uvahealth.org or 434-248-0893.

Trial Title: Feasibility of a Bolus Calculator Without Carbohydrate Counting in Type 1 Diabetes Patients Under Multiple Daily Injections (MDI) Therapy: a Supervised Randomized Controlled Trial (InsuLearn).
IRB-HSR#231610
NCT06411548
PI: Anas El Fathi, PhD
MD: Dr. Ralf Nass
CRC: Emma Emory

The University of Virginia, Department of Diabetes Technology, seeks adults 18 years and older who use multiple daily injections (MDI) to manage their Type 1 Diabetes to participate in a clinical study. The purpose of this study is to improve blood glucose levels after eating meals even when you are not able to exactly measure the carbohydrates in the meal. This study will test an investigational algorithm (complex mathematical formula) called InsuLearn through a smart insulin pen. The pen will recommend the amount of insulin to bolus with your meal and estimate the carbohydrates. We are looking for participants using multiple daily injections (MDI) treatment and having difficulties with counting carbohydrates.

You may be eligible for this study if:

· You were diagnosed with type 1 diabetes at least one year ago.

· You are using MDI treatment for the last six months.

· You are willing to wear a continuous glucose monitor (CGM) during the study.

· You are willing to use insulin smart pen app to record and deliver your insulin doses.

· You are willing to participate in a 51-hour hotel admission.

The study involves:

· 8 study visits during the 6-week study; all visits except for the hotel admission may be completed remotely.

· Wearing a CGM to measure your blood glucose levels.

· Use a smart insulin pen to deliver your insulin, help calculate insulin doses and estimate your carbohydrates for meals.

· Staying at a hotel to test the study algorithm.

The following study-related tests and supplies are provided free of charge:

· Hemoglobin A1c Test (fingerstick)

· CGM supplies

· Smart Insulin Pen

· Glucometer supplies

Compensation: Up to $350 to complete the study

For more information, please email: Emma Emory at EE9M@uvahealth.org

Trial Title: Automated Insulin Delivery for Inpatients with Dysglycemia (AIDING) Randomized Controlled Trial.
NCT06418880
PI/MD: Dr. Sue Brown
CRC: Carlene Alix

Research Volunteers Needed

1. Were you involved in the AIDING Trial?
2. Are you a nurse, or caregiver of someone that participated in the AIDING Trial?

We are collecting feedback from patients and nurses that were directly involved with the AIDING Trial.

Compensation for you time: $20 Gift card for completing the survey $50 Gift card for completing the interview

If you are interested in participating in an interview please contact our team.

For more information, please email: Carlene Alix

Trial Title: A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes (CFRD).
IRB-HSR#231641
NCT06449677
PI/MD: Dr. Sue Brown
CRC: Sara Prince

Click the NCT number for more information.

For more information, please email: Sara Prince at SP4SA@uvahealth.org

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 12 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: $825.00 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

• Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm (AIDANET+BPS_RL).
• Sex Differences In Glucose Control and Diabetes Management (T1D & T2D).
• 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