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Artificial Pancreas
Neural-net Artificial Pancreas (NAP) (NAP Trial)
N/A
Waitlist Available
Led By Sue A Brown, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 hours (two 18-hour experiments)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new smart insulin system (NAP) against an existing one (UMPC) in adults using advanced insulin pumps. Both systems automatically adjust insulin based on blood sugar readings to maintain healthy levels. These systems have been developed to improve type 1 diabetes management by automating insulin delivery without needing extra doses before meals.
Eligible Conditions
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 hours (two 18-hour experiments)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 hours (two 18-hour experiments)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of Time-in-Range (TIR) on NAP Versus UMPC.
Secondary study objectives
Participant Feedback
Percent of Time in Hyperglycemia.
Percent of Time in Hypoglycemia.
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: UMPC first, then NAPExperimental Treatment2 Interventions
Participants will use the UMPC for 18 hours, then switch to NAP for 18 hours.
Group II: NAP first, then UMPCExperimental Treatment2 Interventions
Participants will use the Neural Net Artificial Pancreas (NAP) algorithm for 18 hours. Then switch to the University of Virginia Model-Predictive Control (UMPC) for 18 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neural-net Artificial Pancreas
2023
N/A
~20
University of Virginia Model Predictive Control
2023
N/A
~20
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,687 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,093 Total Patients Enrolled
Boris P Kovatchev, PhDStudy DirectorUniversity of Virginia Center for Diabetes Technology
Sue A Brown, MDPrincipal InvestigatorUniversity of Virginia Center for Diabetes Technology
3 Previous Clinical Trials
85 Total Patients Enrolled