Embecta AID System in Adults With Type 2 Diabetes (EMBRACE-T2D)

A Multicenter, Pivotal, Randomized Controlled Trial Comparing the Safety and Efficacy of an Automated Insulin Delivery System With the Standard of Care in Adults With Type 2 Diabetes (EMBRACE-T2D)

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

Study Overview

• Status: Withdrawn
• Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus (T2DM); T2DM (Type 2 Diabetes Mellitus); T2D; T2DM; Type 2 DM; T2DM With Inadequate Glycemic Control
• Intervention / Treatment: Device: An AID System.; Other: Standard of Care (SC)

Detailed Description

This outpatient study consists of 2 phases.

Phase 1 (Single Arm) will establish the initial safety of the embecta AID system prior to initiating the phase 2 (RCT). Participants will follow the same protocol as the RCT AID group. During the treatment period all participants will undergo supervised exercise and meal challenges.

Phase 2 (Randomized Control Trial (RCT)) will be a 13-week parallel group RCT to evaluate the safety and efficacy with a 2:1 randomization to intervention with AID versus standard of care (SC) insulin therapy. The RCT AID group will use the embeca AID with Tidepool Loop app as well as the Dexcom G6 continuous glucose monitor (CGM).

Participants in both phases will do in-clinic or virtual visits at least monthly for a total of 9 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford
    • Walnut Creek, California, United States, 94598
      • Diablo Research
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Universtiy School of Medicine
  • New York
    • Long Island City, New York, United States, 11106
      • NYC Research
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
  • Texas
    • Dallas, Texas, United States, 10029
      • UT Southwestern
    • Irving, Texas, United States, 75039
      • Tekton Research
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes & Endocrinology
  • Utah
    • Sandy, Utah, United States, 84093
      • DETS Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

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
3. Diagnosis of T2D, per investigator judgment, of at least 6 months duration prior to time of screening. Any permissible diabetes medications, including insulin, to the exclusion sulfonylurea, meglitinide, or repaglinides have been relatively stable for the past 30 days.
4. Currently treated with (1) multiple daily injections of insulin (MDI; defined as using basal insulin and at least one daily prandial injection), (2) an insulin pump without automation or (3) basal insulin without prandial insulin provided that screening HbA1c ≥7.5% (basal-only) for ≥3 months at the time of screening (per participant report and medical records available at the site)
5. Either not using any noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that can have a meaningful effect on glucose levels, or if using, then the dose has been stable for at least 4 weeks prior to screening based on investigator discretion
6. Willing to use U-100 (i.e., insulin lispro or insulin aspart) while using the embecta AID system if assigned to the AID group
7. Willing to not use concentrated insulin above U-100 or inhaled insulin while using the embecta AID system
8. Willing to participate in the study meal and exercise challenges if assigned to AID use in either the Single Arm Phase or the RCT AID group, and have a care partner, trained in hypoglycemia treatment guidelines including glucagon use, present during and immediately after the exercise challenges unless exercise challenges will be done in clinic.
9. Total daily insulin dose (TDD) <300 units/day
10. HbA1c ≤ 11% based on point-of-care or local lab measurement at screening
11. Willing to comply with study procedures, regardless of study arm
12. Able to read and understand English (due to user interface and IFU only being available in English)
13. Willing to have primary care provider and/or primary endocrinologist notified of participation in the trial
14. Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study
15. No medical, psychiatric, or other conditions, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study. This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, or other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse

16. Participant is not capable of becoming pregnant, or if they are capable, they must meet one of the following criteria:

    a. has a negative urine pregnancy test and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. The following contraceptive measures are considered adequate: i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).

ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).

iii. Placement of an intrauterine device or intrauterine hormone- releasing system.

iv. Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).

v. Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.

vi. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.

or b. Participant is of non-childbearing potential due to menopause with at least one year since last menses or a medical condition confirmed by the investigator

Key Exclusion Criteria:

1. Use of an AID system within the last 3 months prior to screening
2. Use of systemic glucocorticoids within the last 8 weeks prior to screening or anticipated use of systemic glucocorticoids during the study (topical or inhaled or local injection into spine/joint -i.e., non-systemic is acceptable)
3. Current use of sulfonylurea, meglitinide, or repaglinides medications (within 30 days prior to screening)
4. Current use of hydroxyurea (within 1 day prior to screening) as hydroxyurea is known to cause falsely high CGM values which could lead to incorrect dosing from the AID system.
5. Has had more than 2 severe hypoglycemic events requiring third party help or hospitalization within the last 6 months prior to screening
6. Lack of reliable telephone service (for contact) or internet (smartphone containing the closed-loop algorithm application)
7. Planned surgery or hospitalization for which use of the embecta AID system would need to be discontinued for more than 7 days
8. Known allergy to medical grade adhesives that precludes use of the embecta AID system or CGM
9. Skin condition at the site(s) that may be used for application of the study CGM or embecta AID system that precludes use of the AID system or CGM
10. Dialysis planned or anticipated for chronic kidney disease in the next 4 months
11. Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 2 months, or sexually active without use of contraception.
12. Current participation in another diabetes or obesity-related interventional clinical trial.
13. Anticipated change of residency or travel for more than 7 days at a time during the study that may, per investigator judgment, interfere with the completion of study visits, contacts, or procedures.
14. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) of, or someone who is, an investigative site personnel directly affiliated with this study or who is an employee of embecta, Tidepool or the JAEB Center for Health Research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; All participants will use the AID system.	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
Experimental: Randomized Controlled Trial (RCT); Subjects will be randomized 2:1 in the AID group to SC group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c change	The change in HbA1c at 13 weeks from baseline	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM-measured time in range 70-180 mg/dL	Glucose metric from CGM	13 weeks
CGM-measured time in tight range 70-140 mg/dL	Glucose metric from CGM	13 weeks
CGM-measured time less than 54 mg/dL (non-inferiority, margin 0.5%)	Glucose metric from CGM	13 weeks
CGM-measured time less than 70 mg/dL (non-inferiority, margin 0.5%)	Glucose metric from CGM	13 weeks
CGM-measured mean glucose	Glucose metric from CGM	13 weeks
CGM-measured time greater than 180 mg/dL	CGM-measured time greater than 180 mg/dL	13 weeks
CGM-measured time greater than 250 mg/dL	Glucose metric from CGM	13 weeks
CGM-measured time less than 70 mg/dL	CGM-measured time less than 70 mg/dL	13 weeks
CGM-measured time less than 54 mg/dL	Glucose metric from CGM	13 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Severe hypoglycemia events	Severe hypoglycemia events as reported by PI	13 weeks
Safety - Diabetic ketoacidosis (DKA) events	Diabetic ketoacidosis (DKA) events as reported by PI	13 weeks
Safety - Hyperosmolar hyperglycemic (HHS) events	Hyperosmolar hyperglycemic (HHS) events as reported by PI	13 weeks
Safety - Other serious adverse events	Other serious adverse events as reported by PI	13 weeks
Safety - Unanticipated adverse device effects	Unanticipated adverse device effects as reported by PI	13 weeks
Safety - CGM-measured time less than 54 mg/dL	Glucose metric from CGM	13 weeks
Safety- CGM-measured hyperglycemia events	Glucose metric from CGM	13 weeks
Safety - CGM-measured hypoglycemia events	Glucose metric from CGM	13 weeks
Total daily insulin delivery	Insulin delivery metric from app	13 weeks
Percentage of insulin delivered as basal	Percentage of insulin delivered as basal	13 weeks
Weight change	Weight change from baseline to end of study as measured by PI	13 weeks
Type 2 Diabetes Distress Assessment System Core (T2-DDAS Core)	Type 2 Diabetes Distress Assessment System Core (T2-DDAS Core) as reported by participant	13 weeks
DAWN Impact of Diabetes Profile (DIDP)	DAWN Impact of Diabetes Profile (DIDP)	13 weeks
Diabetes Impact and Satisfaction (DIDS) Scale	Diabetes Impact and Satisfaction (DIDS) Scale as reported by participant	13 weeks
WHO-5	WHO-5	13 weeks
Insulin Device Satisfaction Survey (IDSS)	Insulin Device Satisfaction Survey (IDSS) as reported by participant	13 weeks
Sleep Scale	Sleep Scale	13 weeks
System Usability Scale (SUS)	System Usability Scale (SUS) as reported by participant	13 weeks
Hypoglycemia Fear Survey II-Worry subscale only	Hypoglycemia Fear Survey II-Worry subscale only as reported by participant	13 weeks
EQ5D-5L	EQ5D-5L as reported by participant	13 weeks
Study-specific survey	Study-specific survey as reported by participant	13 weeks

Collaborators and Investigators

• Sponsor: Embecta Corp.
• Collaborators: Jaeb Center for Health Research
• Investigators: Study Chair: Rayhan Lal, M.D., Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Type 2 Diabetes Mellitus; T2D; Automated Insulin Delivery; IDD; AID system; AID; Insulin Delivery Device
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: CLN202401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes