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Automated Insulin Delivery

Behavioral Adaptation Module (BAM) for Type 1 Diabetes

N/A
Waitlist Available
Led By Sue 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 6 weeks
Awards & highlights

Summary

The purpose of this pilot study is to test the safety and feasibility of using two or three research modules in conjunction with an automated insulin delivery device (AID).

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules.
Secondary study objectives
INSPIRE Questionnaire
Time in Hypoglycemia
Time in Range

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment4 Interventions
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Group II: Group 1Experimental Treatment3 Interventions
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auto Titration Module (ATM)
2021
N/A
~40
Automated Insulin Delivery (AID) System
2021
N/A
~40
Web Simulation Tool (WST)
2021
N/A
~40
Behavioral Adaptation Module (BAM)
2021
N/A
~40

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,266 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,860 Total Patients Enrolled
Sue Brown, MDPrincipal Investigator - University of Virginia
UVA-HealthSouth Rehabilitation Hospital
University Of Virginia School Of Medicine (Medical School)
University Of Nc Hosps (Residency)
15 Previous Clinical Trials
1,009 Total Patients Enrolled
~8 spots leftby Sep 2025
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