Clinical trial NCT02434094: Development of a Comprehensive AP Training Curriculum for Adults
Official title: Development of a Comprehensive AP Training Curriculum for Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Assistant (DiAs)
Continuous Glucose Monitor (CGM)
Insulin Pump
Human Factors
Focus Group
Artificial Pancreas (AP)
eDAPT (electronic Diabetes Artificial Pancreas Training)
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility 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

Primary outcomes:
measure: Validated eDAPT training tool
timeFrame: 2 hours
measure: Human factors feedback
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: UVA Center for Diabetes Technology
name: Sue Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: