Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery
The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is: Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)? Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care. Participants will: Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks
• Age at time of consent \>18 and \<89 years
• Either 2.a. or 2.b.:
∙ Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year
‣ Clinical diagnosis of type 2 diabetes, on current injected or infused insulin regimen for at least 3 months prior to screening (e.g., basal-bolus, basal only, or pre-mix)
• Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA) and GLP-1/GIP RA agents
• Stable doses of weight loss medications (including GLP-1 RA and GLP-1/GIP RA agents) over the preceding 4 weeks as determined by the investigator.
• For those using the iLet Bionic Pancreas (during the RCT arm or observational extension phase), willingness to stay on current doses of medications throughout the study that may affect glycemia directly and/or indirectly, except for a dose reduction or discontinuation.
• Have a primary care clinician willing to refer them to the study, confirm their diabetes diagnosis (for example: type 1 diabetes or type 2 diabetes), and recommend and manage the iLet for the duration of the study
• Willing to comply with all study procedures for the duration of the study
• Willing to wear a Dexcom CGM device and iLet system for duration of time randomized to iLet use or OEP
• Willing to use the following insulin: lispro (including non-branded lispro and Humalog) or aspart (including non-branded aspart, Fiasp, and Novolog)
⁃ Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
⁃ Willing and able to sign and date the Informed Consent Form (ICF)
⁃ If capable of becoming pregnant, willing and able to have pregnancy testing and use an acceptable method of contraception during the study period
⁃ a. Capable of becoming pregnant means that menstruation has started and the participant is not surgically sterile or post-menopausal (12 months without menses) b. Acceptable methods of contraception include: 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.
⁃ Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration
⁃ Have hardware and internet access capable of 2-way video and audio communication