Development of a Comprehensive AP Training Curriculum for Adults

October 24, 2016 updated by: Sue Brown, University of Virginia
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Center for Diabetes Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • clinicians who manage patients on insulin pumps and continuous glucose monitors
  • participants former study participants who have experience operating DiAs.
  • participants who wear an insulin pump and continuous glucose monitor but have no experience DiAs.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T1DM Clinicians
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.
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.
T1DM Subjects with DiAs experience
T1DM subjects will prior DiAs experience will be asked to complete the eDAPT on-line training program.
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.
T1DM Subjects with no prior DiAs experience
T1DM subjects will no prior DiAs experience will be asked to complete the eDAPT on-line training program.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validated eDAPT training tool
Time Frame: 2 hours
Subjects learn how to properly operate & configure DiAs.
2 hours
Human factors feedback
Time Frame: 2 hours
Administration of knowledge tests and focus groups
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Sue Brown, MD, UVA Center for Diabetes Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (ESTIMATE)

May 5, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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