Development of a Comprehensive AP Training Curriculum for Adults
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Behavioral: eDAPT on-line training program
- Registration Number
- NCT02434094
- Lead Sponsor
- University of Virginia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description T1DM Subjects with no prior DiAs experience eDAPT on-line training program T1DM subjects will no prior DiAs experience will be asked to complete the eDAPT on-line training program. T1DM Clinicians eDAPT on-line training program Clinicals currently teaching T1DM patients how to use insulin pumps and continuous glucose monitors will be asked to complete the eDAPT on-line training program. T1DM Subjects with DiAs experience eDAPT on-line training program T1DM subjects will prior DiAs experience will be asked to complete the eDAPT on-line training program.
- Primary Outcome Measures
Name Time Method Human factors feedback 2 hours Administration of knowledge tests and focus groups
Validated eDAPT training tool 2 hours Subjects learn how to properly operate \& configure DiAs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Virginia Center for Diabetes Technology
🇺🇸Charlottesville, Virginia, United States