Current Studies

Algorithmic Development, Prototyping, and Pilot Clinical Testing of a Therapy Optimization Platform to Support Healthcare Providers in the Management of Type 2 Diabetes (DSS-HCP-T2)

Questions

For more information, please contact: Jasmeen Dhillon

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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 (DSS-HCP-T2)
HSR#220327
PI: Chiara Fabris, Ph.D
CRC: Jasmeen Dhillon

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. You need to also be currently using a Dexcom G6 Continuous Glucose Monitor (CGM). 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.  

If you agree to participate, this study will involve a screening appointment that 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 we will also ask to collect about 30 days of data obtained from your Dexcom G6 Continuous Glucose Monitor (CGM) data.     

Study duration is approximately 30 days (5 visits total). The screening visit and check in visits may be completed in person, telephone, or videoconferencing.  

You may need a hemoglobin A1c blood test that will be provided free of charge.

Questions

For more information, please contact: Jasmeen Dhillon

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Adaptive Behavioral Control (ABC) in a Closed-Loop System: A Randomized Crossover Clinical Trial

Questions

For more information, please contact: Carlene Alix

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Trial Title: Adaptive Behavioral Control (ABC) in a Closed-Loop System: A Randomized Crossover Clinical Trial
HSR#220300
PI: 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). 

Questions

For more information, please contact: Carlene Alix

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Artificial Pancreas - Adolescent Physiology & Psychology Longitudinal Evaluation (AP APPLE)

Questions

For more information, please contact: Lianna Smith

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Trial Title: Artificial Pancreas – Adolescent Physiology & Psychology Longitudinal Evaluation (AP APPLE)
IRB-HSR#19088
PI: 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.

Questions

For more information, please contact: Lianna Smith

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Adapting Diabetes Treatment Expert Systems to Patient's Expectations and Psychobehavioral Characteristics in Type 1 Diabetes (DSS 2)

Questions?

For more information, please contact: Emma Emory

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Trial Title: Adapting Diabetes Treatment Expert Systems to Patient’s Expectations and Psychobehavioral Characteristics in  Type 1 Diabetes (DSS2)
IRB-HSR: #200007
PI: Marc Breton
RC: Emma Emory

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.

Questions?

For more information, please contact: Emma Emory

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A Phase I/II, Open-Arm Study Evaluating the Safety of Islet Transplant on Patients with Type 1 Diabetes

Questions?

For more information, please email: Robin Kelly, RN

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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

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.

Questions?

For more information, please email: Robin Kelly, RN

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Interested in Participating in a Trial?

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