Development of a Comprehensive AP Training Curriculum for Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development of a Comprehensive AP Training Curriculum for Adults

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: eDAPT on-line training program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T1DM Clinicians<br>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<br>* A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.<br>|
| T1DM Subjects with DiAs experience<br>T1DM subjects will prior DiAs experience will be asked to complete the eDAPT on-line training program. | Behavioral: eDAPT on-line training program<br>* A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.<br>|
| T1DM Subjects with no prior DiAs experience<br>T1DM subjects will no prior DiAs experience will be asked to complete the eDAPT on-line training program. | Behavioral: eDAPT on-line training program<br>* A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Glucose Monitor (CGM), Insulin Pump, Human Factors, Focus Group, Artificial Pancreas (AP), eDAPT (electronic Diabetes Artificial Pancreas Training), Diabetes Assistant (DiAs)