Development of a Comprehensive AP Training Curriculum for Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- University of Virginia
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Human factors feedback
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
An e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).
Detailed Description
This project will develop and test a comprehensive, web based training system for the artificial pancreas (AP) prototype identified as eDAPT (electronic Diabetes Artificial Pancreas Training). This e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs), a software platform for the development and outpatient testing of smart phone based systems for Closed Loop Control of diabetes. The e-learning training program will be used in adjunct to in-person training with study staff at the onset of a clinical trial. It will be especially important as the number of clinical sites that use DiAs continue to grow both in the United States and internationally. It is also a critical step in moving the DiAs closer to a commercial product. A validated training program is required to proceed with the Food and Drug Administration (FDA) for both pivotal clinical trials and commercial approval of the AP.
Investigators
Sue Brown
Principal Investigator
University of Virginia
Eligibility Criteria
Inclusion Criteria
- •Endocrinologist, Certified Diabetes Educator, Nurse Practitioner actively managing patients with type 1 diabetes on insulin pumps and continuous glucose monitoring therapy
- •Actively managing patients using insulin pumps for at least one year
- •Former \& Novice Study Subjects Inclusion Criteria:
- •Have Type 1 Diabetes Mellitus as defined by American Diabetes Association criteria or judgment of physician for at least 1 year
- •No previous experience with the artificial pancreas system in a clinical trial
- •Currently using insulin pump to manage their type 1 diabetes for at least one year
- •Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin
- •Knowledge of continuous glucose monitors
- •Former Study Subjects Inclusion Criteria:
- •Previous experience with the artificial pancreas system in a clinical trial
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Human factors feedback
Time Frame: 2 hours
Administration of knowledge tests and focus groups
Validated eDAPT training tool
Time Frame: 2 hours
Subjects learn how to properly operate \& configure DiAs.