CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Web Simulation Tool (WST) +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04784637
NCT04784637N/ACompleted
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Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery: A Randomized, Controlled Pilot Study

University of Virginia·interventional·Posted Mar 5, 2021·Updated Nov 7, 2024

In Brief

A clinical study evaluating Web Simulation Tool (WST), Behavioral Adaptation Module (BAM), and 2 other interventions for Type 1 Diabetes Mellitus. Completed, enrolled 31 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 5, 2021
Enrollment StartJul 23, 2021
Primary CompletionDec 24, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.3 years ago

Interventions

Web Simulation Tool (WST)device

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

Behavioral Adaptation Module (BAM)device

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

Auto Titration Module (ATM)device

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

Automated Insulin Delivery (AID) Systemdevice

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