Development of a Comprehensive AP Training Curriculum for Adults

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Development of a Comprehensive AP Training Curriculum for Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434094
• Other study ID #: 18032
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: October 24, 2016
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validated eDAPT training tool	Subjects learn how to properly operate & configure DiAs.	2 hours	No
Primary	Human factors feedback	Administration of knowledge tests and focus groups	2 hours	No