Development of a Comprehensive AP Training Curriculum for Adults

University of Virginia

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: eDAPT on-line training program

Study type: Observational

Funder types: Other

Identifiers

NCT02434094

18032

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

24 participants in 3 patient groups

T1DM Clinicians

Description:

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.

Treatment:

Behavioral: eDAPT on-line training program

T1DM Subjects with DiAs experience

Description:

T1DM subjects will prior DiAs experience will be asked to complete the eDAPT on-line training program.

Treatment:

Behavioral: eDAPT on-line training program

T1DM Subjects with no prior DiAs experience

Description:

T1DM subjects will no prior DiAs experience will be asked to complete the eDAPT on-line training program.

Treatment:

Behavioral: eDAPT on-line training program