Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of a Comprehensive AP Training Curriculum for Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434094
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Sue Brown, University of Virginia

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Behavioral: eDAPT on-line training program

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Development of a Comprehensive AP Training Curriculum for Adults
Study Start Date : April 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Validated eDAPT training tool [ Time Frame: 2 hours ]
    Subjects learn how to properly operate & configure DiAs.

  2. Human factors feedback [ Time Frame: 2 hours ]
    Administration of knowledge tests and focus groups


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434094


Locations
Layout table for location information
United States, Virginia
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Investigators
Layout table for investigator information
Principal Investigator: Sue Brown, MD UVA Center for Diabetes Technology
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sue Brown, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT02434094    
Other Study ID Numbers: 18032
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Keywords provided by Sue Brown, University of Virginia:
Diabetes Assistant (DiAs)
Continuous Glucose Monitor (CGM)
Insulin Pump
Human Factors
 Focus Group
Artificial Pancreas (AP)
eDAPT (electronic Diabetes Artificial Pancreas Training)
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases