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Adaptive Biobehavioral Control (ABC) in a Closed-Loop System

NCT05610111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-05-15

No results posted yet for this study

Summary

This study is intended to test a Web-based Information Tool (WIT) software providing additional information regarding time in range, GMI, hypo- and hyperglycemia risks, variability tracker, daily glycemic profiles, and potential changes of insulin pump parameters, to users of a commercially available Closed-Loop Control (CLC) System (Control-IQ Technology).

Conditions

Interventions

DEVICE

CLC + BAM

Closed Loop Control with the Behavioral Adaption Module for 4 weeks

DEVICE

CLC + ABC

Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks

Sponsors & Collaborators

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

    collaborator NIH

  • Tandem Diabetes Care, Inc.

    collaborator INDUSTRY

  • Sue Brown

    lead OTHER

Principal Investigators

  • Sue Brown, MD · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2024-09-26
Completion
2024-09-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05610111 on ClinicalTrials.gov