Development of a Comprehensive AP Training Curriculum for Adults
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | April 2015 |
| End Date: | August 2015 |
| Contact: | Jessica Robic, BA |
| Email: | JLR8YQ@VIRGINIA.EDU |
| Phone: | 434-982-3459 |
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).
the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).
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.
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.
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
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