Development of a Comprehensive AP Training Curriculum for Adults
1 other identifier
observational
24
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 25, 2016
October 1, 2016
3 months
April 29, 2015
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Validated eDAPT training tool
Subjects learn how to properly operate \& configure DiAs.
2 hours
Human factors feedback
Administration of knowledge tests and focus groups
2 hours
Study Arms (3)
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.
T1DM Subjects with DiAs experience
T1DM subjects will prior DiAs experience will be asked to complete the eDAPT on-line training program.
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.
Interventions
A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.
Eligibility Criteria
* 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.
You may qualify if:
- 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
- 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
- Previous experience with the artificial pancreas system in a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sue Brown, MD
UVA Center for Diabetes Technology
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 5, 2015
Study Start
April 1, 2015
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
October 25, 2016
Record last verified: 2016-10