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Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®

NCT05325294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2025-01-15

Study results available
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Summary

This US study will evaluate the safety and effectiveness of utilizing insulin Lyumjev® lispro-aabc in the MiniMed™ 780G System in Type 1 adult and pediatric subjects in a home setting to support product and system labeling.

Conditions

Interventions

DEVICE

MiniMed 780G System

MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2024-01-03
Completion
2024-01-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05325294 on ClinicalTrials.gov