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Embecta AID System in Adults With Type 2 Diabetes

NCT06692153 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-12-16

No results posted yet for this study

Summary

This is a multi-center, randomized control study that will evaluate the safety and effectiveness of the embecta Automated Insulin Delivery System in adults with Type 2 diabetes requiring insulin therapy

Conditions

  • Type 2 Diabetes
  • Type 2 Diabetes Mellitus (T2DM)
  • Type 2 DM
  • T2DM With Inadequate Glycemic Control
  • T2DM (Type 2 Diabetes Mellitus)
  • T2D
  • T2DM

Interventions

DEVICE

An AID System.

The embecta Automated Insulin Delivery (AID) System is a closed loop system comprised of 3 components: the embecta insulin pump, a Smartphone with the Tidepool Loop app, and the Dexcom G6 CGM

OTHER

Standard of Care (SC)

Participants will continue to use their current therapy for T2D.

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • Embecta Corp.

    lead INDUSTRY

Principal Investigators

  • Rayhan Lal, M.D. · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-03-31
Completion
2026-05-31
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 NCT06692153 on ClinicalTrials.gov