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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
Full 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.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
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
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:
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:
Primary purpose
Allocation
Interventional model
Masking
360 participants in 2 patient groups
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Central trial contact
Tracey Wielinski, M.S.; Henry Anhalt, D.O.
Data sourced from clinicaltrials.gov
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