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Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery

NCT04784637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-11-07

Study results available
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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).

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Web Simulation Tool (WST)

WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.

DEVICE

Behavioral Adaptation Module (BAM)

BAM provides on-demand information to the participant primarily on glycemic risks.

DEVICE

Auto Titration Module (ATM)

ATM provides recommendations to the participant to periodically update insulin parameters.

DEVICE

Automated Insulin Delivery (AID) System

The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Sue Brown, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-23
Primary Completion
2021-12-24
Completion
2021-12-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04784637 on ClinicalTrials.gov