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Automated Insulin Delivery System

Randomized Controlled Trial (RCT) for Type 2 Diabetes (EMBRACE-T2D Trial)

N/A
Waitlist Available
Research Sponsored by Embecta Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form
2. ≥18 years of age at time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights
No Placebo-Only Group

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

Eligible Conditions
  • Type 2 Diabetes
  • Uncontrolled diabetes
  • Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HbA1c change
Secondary study objectives
CGM-measured mean glucose
CGM-measured time greater than 180 mg/dL
CGM-measured time greater than 250 mg/dL
+6 more
Other study objectives
DAWN Impact of Diabetes Profile (DIDP)
Diabetes Impact and Satisfaction (DIDS) Scale
EQ5D-5L
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
All participants will use the AID system.
Group II: Randomized Controlled Trial (RCT)Experimental Treatment2 Interventions
Subjects will be randomized 2:1 in the AID group to SC group.

Find a Location

Who is running the clinical trial?

Embecta Corp.Lead Sponsor
Jaeb Center for Health ResearchOTHER
158 Previous Clinical Trials
35,589 Total Patients Enrolled
Rayhan Lal, M.D.Study ChairStanford University
~240 spots leftby Mar 2026
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