NCT02434094

Development of a Comprehensive AP Training Curriculum for Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BEHAVIORAL	eDAPT on-line training program	A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2015-05-05
• Last updated: 2016-10-25

Locations

1 site across 1 country: United States