Expired Study
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Charlottesville, Virginia 22903


Purpose:

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).


Study summary:

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.


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


NCT ID:

NCT02434094


Primary Contact:

Principal Investigator
Sue Brown, MD
UVA Center for Diabetes Technology


Backup Contact:

N/A


Location Contact:

Charlottesville, Virginia 22903
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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