Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes Assistant (DiAs), Continuous Glucose Monitor (CGM), Insulin Pump, Human Factors, Focus Group, Artificial Pancreas (AP), eDAPT (electronic Diabetes Artificial Pancreas Training)
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.
Interventions
BEHAVIORALeDAPT on-line training program
A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.
Sponsors
University of Virginia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Diabetes Clinicians 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validated eDAPT training tool | 2 hours | Subjects learn how to properly operate & configure DiAs. |
| Human factors feedback | 2 hours | Administration of knowledge tests and focus groups |
Countries
United States
Outcome results
None listed