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Artificial Pancreas

NAP first, then UMPC for Type 1 Diabetes (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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 hours (two 18-hour experiments) for reporting.

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 more

Awards & 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