Type 2 DiabetesEMBRACE-T2DNCT06692153
Embecta AID System in Adults With Type 2 Diabetes
A study testing An AID System. in people with Type 2 Diabetes and Type 2 Diabetes Mellitus (T2DM), run by Embecta Corp. at 9 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Type 2 DM
- What is being tested?
- An AID System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2025to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
- 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
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- 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:
- 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).
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
- Placement of an intrauterine device or intrauterine hormone- releasing system.
- Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).
- Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
UT Southwestern
Dallas, Texas, 10029
Indiana Universtiy School of Medicine
Indianapolis, Indiana, 46202
Tekton Research
Irving, Texas, 75039
NYC Research
Long Island City, New York, 11106
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Stanford
Palo Alto, California, 94304
Texas Diabetes & Endocrinology
Round Rock, Texas, 78681
DETS Utah
Sandy City, Utah, 84093
Diablo Research
Walnut Creek, California, 94598
About this study
Official title: 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
Read the 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.
- Conditions
- Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Type 2 DM, T2DM With Inadequate Glycemic Control, T2DM (Type 2 Diabetes Mellitus), T2D
- Being tested
- An AID System., Standard of Care (SC)
- Keywords
- AID system, AID, T2D, Type 2 Diabetes, Type 2 Diabetes Mellitus, IDD, Insulin Delivery Device, Automated Insulin Delivery
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Standard of Care (SC)Other
Participants will continue to use their current therapy for T2D.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All participants will use the AID system. Receives: Device: An AID System. |
| Randomized Controlled Trial (RCT) | Experimental | Subjects will be randomized 2:1 in the AID group to SC group. Receives: Device: An AID System.; Other: Standard of Care (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change
The change in HbA1c at 13 weeks from baseline
Measured: 13 weeks
Secondary outcomes (9)
CGM-measured time in range 70-180 mg/dL
Glucose metric from CGM
Measured: 13 weeks
CGM-measured time in tight range 70-140 mg/dL
Glucose metric from CGM
Measured: 13 weeks
CGM-measured time less than 54 mg/dL (non-inferiority, margin 0.5%)
Glucose metric from CGM
Measured: 13 weeks
CGM-measured time less than 70 mg/dL (non-inferiority, margin 0.5%)
Glucose metric from CGM
Measured: 13 weeks
CGM-measured mean glucose
Glucose metric from CGM
Measured: 13 weeks
CGM-measured time greater than 180 mg/dL
CGM-measured time greater than 180 mg/dL
Measured: 13 weeks
CGM-measured time greater than 250 mg/dL
Glucose metric from CGM
Measured: 13 weeks
CGM-measured time less than 70 mg/dL
CGM-measured time less than 70 mg/dL
Measured: 13 weeks
CGM-measured time less than 54 mg/dL
Glucose metric from CGM
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study startJan 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: Program was discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (RCT)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Embecta Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
- Investigators
- Rayhan Lal, M.D., Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692153
- Sponsor's protocol ID
- CLN202401
- Acronym
- EMBRACE-T2D
- Status last verified
- Dec 2024
- First submitted
- 14 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06692153
- Acronym / sponsor ID
- EMBRACE-T2D / CLN202401
- Conditions
- Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Type 2 DM, T2DM With Inadequate Glycemic Control, T2DM (Type 2 Diabetes Mellitus), T2D
- Keywords
- AID system, AID, T2D, Type 2 Diabetes, Type 2 Diabetes Mellitus, IDD, Insulin Delivery Device, Automated Insulin Delivery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Program was discontinued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Embecta Corp.Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- Jan 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: An AID System.All participants will use the AID system. |
| Randomized Controlled Trial (RCT) | Experimental | Device: An AID System., Other: Standard of Care (SC)Subjects will be randomized 2:1 in the AID group to SC group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
- 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.
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Randomized Controlled Trial (RCT), Single Arm |
| Standard of Care (SC)Participants will continue to use their current therapy for T2D. | Other | Randomized Controlled Trial (RCT) |
Primary outcome
HbA1c change
Time frame: 13 weeks
The change in HbA1c at 13 weeks from baseline
9 secondary outcomes
CGM-measured time in range 70-180 mg/dL
Time frame: 13 weeks
CGM-measured time in tight range 70-140 mg/dL
Time frame: 13 weeks
CGM-measured time less than 54 mg/dL (non-inferiority, margin 0.5%)
Time frame: 13 weeks
CGM-measured time less than 70 mg/dL (non-inferiority, margin 0.5%)
Time frame: 13 weeks
CGM-measured mean glucose
Time frame: 13 weeks
CGM-measured time greater than 180 mg/dL
Time frame: 13 weeks
CGM-measured time greater than 250 mg/dL
Time frame: 13 weeks
CGM-measured time less than 70 mg/dL
Time frame: 13 weeks
CGM-measured time less than 54 mg/dL
Time frame: 13 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rayhan Lal, M.D. study chair
Stanford University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An AID System. in people with Type 2 Diabetes and Type 2 Diabetes Mellitus (T2DM), run by Embecta Corp. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c change (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.