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Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

NCT05204134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-04-05

Study results available
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Summary

Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.

Conditions

Interventions

DEVICE

Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.

Sponsors & Collaborators

  • Tandem Diabetes Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Jordan E Pinsker, MD · Tandem Diabetes Care, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2022-09-09
Completion
2022-09-29
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05204134 on ClinicalTrials.gov