Embecta AID System in Adults With Type 2 Diabetes

NCT06692153 | Withdrawn DMC FDA Device

• 1 other identifier: CLN202401
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

AID system; AID; T2D; Type 2 Diabetes; Type 2 Diabetes Mellitus; IDD; Insulin Delivery Device; Automated Insulin Delivery

Outcome Measures

Primary Outcomes (1)

• HbA1c change

  The change in HbA1c at 13 weeks from baseline

  13 weeks

Secondary Outcomes (9)

• CGM-measured time in range 70-180 mg/dL

  13 weeks

• CGM-measured time in tight range 70-140 mg/dL

  13 weeks

• CGM-measured time less than 54 mg/dL (non-inferiority, margin 0.5%)

  13 weeks

• CGM-measured time less than 70 mg/dL (non-inferiority, margin 0.5%)

  13 weeks

• CGM-measured mean glucose

  13 weeks

Other Outcomes (21)

• Safety - Severe hypoglycemia events

  13 weeks

• Safety - Diabetic ketoacidosis (DKA) events

  13 weeks

• Safety - Hyperosmolar hyperglycemic (HHS) events

  13 weeks

Study Arms (2)

Single Arm

EXPERIMENTAL

All participants will use the AID system.

Device: An AID System.

Randomized Controlled Trial (RCT)

EXPERIMENTAL

Subjects will be randomized 2:1 in the AID group to SC group.

Device: An AID System.; Other: Standard of Care (SC)

Interventions

An AID System. DEVICE

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

Randomized Controlled Trial (RCT); Single Arm

Standard of Care (SC) OTHER

Participants will continue to use their current therapy for T2D.

Randomized Controlled Trial (RCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form
• ≥18 years of age at time of consent
• 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)
• 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
• Willing to use U-100 (i.e., insulin lispro or insulin aspart) while using the embecta AID system if assigned to the AID group
• Willing to not use concentrated insulin above U-100 or inhaled insulin while using the embecta AID system
• 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.
• Total daily insulin dose (TDD) \<300 units/day
• HbA1c ≤ 11% based on point-of-care or local lab measurement at screening
• Willing to comply with study procedures, regardless of study arm
• Able to read and understand English (due to user interface and IFU only being available in English)
• Willing to have primary care provider and/or primary endocrinologist notified of participation in the trial
• 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
• 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
• Participant is not capable of becoming pregnant, or if they are capable, they must meet one of the following criteria:

You may not qualify if:

• Use of an AID system within the last 3 months prior to screening
• 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)
• Current use of sulfonylurea, meglitinide, or repaglinides medications (within 30 days prior to screening)
• 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.
• Has had more than 2 severe hypoglycemic events requiring third party help or hospitalization within the last 6 months prior to screening
• Lack of reliable telephone service (for contact) or internet (smartphone containing the closed-loop algorithm application)
• Planned surgery or hospitalization for which use of the embecta AID system would need to be discontinued for more than 7 days
• Known allergy to medical grade adhesives that precludes use of the embecta AID system or CGM
• 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
• Dialysis planned or anticipated for chronic kidney disease in the next 4 months
• Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 2 months, or sexually active without use of contraception.
• Current participation in another diabetes or obesity-related interventional clinical trial.
• 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.
• 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.

Sponsors & Collaborators

• Embecta Corp.: lead
• Jaeb Center for Health Research: collaborator

Study Sites (9)

Stanford

Palo Alto, California, 94304, United States

Location

Diablo Research

Walnut Creek, California, 94598, United States

Location

Indiana Universtiy School of Medicine

Indianapolis, Indiana, 46202, United States

Location

NYC Research

Long Island City, New York, 11106, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

UT Southwestern

Dallas, Texas, 10029, United States

Location

Tekton Research

Irving, Texas, 75039, United States

Location

Texas Diabetes &amp; Endocrinology

Round Rock, Texas, 78681, United States

Location

DETS Utah

Sandy City, Utah, 84093, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rayhan Lal, M.D.

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

US (9)