Current Studies

Current Studies

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Actively Recruiting

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

Trial Title: Artificial Pancreas – Adolescent Physiology & Psychology Longitudinal Evaluation (AP APPLE)
IRB-HSR#19088
PI: Mark DeBoer, MD
RC: Laura Kollar, RN

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 (if provided) are free of change.

For more information, please contact: Laura Kollar, LLK7M@hscmail.mcc.virginia.edu

Glycemic Profiles and Insulin Delivery Across the Menstrual Cycle in Women with Type 1 Diabetes

Trial Title: Glycemic Profiles and Insulin Delivery Across the Menstrual Cycle in Women with Type 1 Diabetes
IRB-HSR#190046
PI: Chiara Fabris, PhD
RC: Lianna Smith

The Center for Diabetes Technology seeks women ages 18 to 40 with Type 1 Diabetes for a research study.

The purpose of the study is find out how much the menstrual cycle effects the blood glucose variability and the effectiveness of insulin delivery. You may be eligible for this study if you are a woman who has had type 1 diabetes for at least 1 year, have used an insulin pump for at least 6 months, your A1c is under 8.5% (tested within 6 months), and have used a Continuous Glucose Monitor (CGM) in the last 6 months.

  • Your participation in this study will last about 3 months and involve about 5 visits.
  • The first visit is a screening visit to determine the safety of your participation and includes a review of your medical history, a urine pregnancy test, and a physical exam. After the screening visit, you will be trained on the study equipment which includes a CGM and Activity Tracker.
  • You will also be asked to track information about your cycle into an App, the amount of carbohydrate you consume each day, download your data on a regular basis and, if not using an oral contraceptive, perform ovulation tests.
  • You will have check-in visits with study staff at least once a month. The final visit includes return of study equipment, a urine pregnancy test and a fingerstick A1c test.  Study visits may be completed in person or completed virtually.

Study-related supplies, exams, and A1c testing (if needed) provided free of charge. Compensation is provided.

For more information, please contact: Lianna Smith, lhs7px@hscmail.mcc.virginia.edu

Adapting Diabetes Treatment Expert Systems to Patient’s Expectations and Psychobehavioral Characteristics in Type 1 Diabetes

Trial Title: Adapting Diabetes Treatment Expert Systems to Patient’s Expectations and Psychobehavioral Characteristics in  Type 1 Diabetes
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 are currently using an insulin pump, your A1c is between 6.5% – 11%, and you have had type 1 diabetes for at least 1 year.
  • This study involves using a Tandem t:slim X2 pump, Dexcom G6 sensors, and an investigational diabetes application on an Android smart phone.
  • 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. Most of these visits will be completed virtually using a web-based video conferencing tool.

Study-related Dexcom G6 sensors, transmitters, and infusion sets will be provided free of charge.

For more information, please contact: Emma Emory, ee9m@hscmail.mcc.virginia.edu

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

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 change.
  • No compensation is provided for this study.

For more information, please email Robin Kelly, RN,  transplantresearch@virginia.edu

Closed to Enrollment

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

Results Pending

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

 

Completed Studies

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