Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are older than 18 and younger than 89 years of age at the time of signing consent
• People who have been clinically diagnosed with type 1 diabetes for at least one year and have been using insulin for at least one year
• People who have been clinically diagnosed with type 2 diabetes and have been on an injected or infused insulin regimen for at least 3 months before screening
• People whose doses of blood sugar–lowering medications have been stable for the past 4 weeks, including certain newer injectable diabetes medications (confirm with trial site)
• People whose doses of weight loss medications have been stable for the past 4 weeks
• People willing to stay on their current medication doses throughout the study, with exceptions only for dose reductions or stopping a medication (for those using the iLet device)
• People who have a primary care doctor willing to refer them to the study, confirm their diabetes diagnosis, and manage the iLet device throughout the study
• People willing to follow all study procedures for the full duration of the study
• People willing to wear a Dexcom continuous glucose monitor (CGM) and the iLet device for the required periods
• People willing to use one of the specified fast-acting insulin types: lispro (including Humalog) or aspart (including Fiasp or Novolog)
• People who the investigator believes have the thinking ability and skills needed to safely operate all study devices and follow the study plan
• People willing and able to read, sign, and date the informed consent form
• People who are capable of becoming pregnant and are willing to undergo pregnancy testing and use an accepted method of contraception during the study (accepted methods include hormonal contraception, intrauterine devices, barrier methods such as condoms with spermicide, a vasectomised sole partner, or complete sexual abstinence)
• People willing to follow the lifestyle guidelines set out in the study protocol
• People who have access to a device and internet connection capable of two-way video and audio calls

Who may not be able to join:

• People who cannot safely follow study procedures due to difficulties with vision, hand coordination, or memory
• People who are unable to speak and read English, as the device and support materials are only available in English
• People who have been diagnosed with a specific rare genetic form of diabetes called maturity-onset diabetes of the young (MODY)
• People who plan to make significant changes to their diabetes treatment between screening and the start of the study (such as switching insulin delivery method or starting a new class of diabetes medication)
• People who weigh more than 255 kg (561 pounds), as this is the maximum weight the iLet device can accept
• People who have had weight-loss (bariatric) surgery in the 12 months before joining, or who plan to have it during the study
• People currently using a non–FDA-approved closed-loop insulin delivery system (such as DIY Loop, AAPS, iAPS, or Open APS)
• People with a diagnosed blood disorder involving the breakdown of red blood cells (such as sickle cell disease or thalassaemia) that could affect the accuracy of a key diabetes blood test (HbA1c)
• People who plan to use hydroxyurea at any dose, or acetaminophen (paracetamol) at doses greater than 1 gram every 6 hours
• People who plan to receive a blood transfusion during the study, or who have received one within 3 months before joining
• People currently participating in another diabetes-related clinical trial
• People whose diabetes was caused by cystic fibrosis, pancreatitis, or another pancreatic condition, or who have had their entire pancreas removed
• People who have used oral or injected steroid medications (glucocorticoids) on and off in the 8 weeks before screening, or who plan to use them during the study (note: stable, ongoing steroid use may be acceptable — confirm with trial site)
• People who have had more than one episode of a serious diabetes complication called diabetic ketoacidosis (DKA) or hyperglycaemic hyperosmolar syndrome (HHS) in the 6 months before screening, where those episodes were not caused by illness or a device problem
• People with a known allergy or severe skin reaction to the adhesives or tapes required for study devices
• People currently taking, or who have taken in the past 30 days, or who plan to start taking, certain diabetes medications including sulfonylureas, pramlintide, or SGLT-2 inhibitors
• People who have major surgery planned during the study period
• People who are pregnant, breastfeeding, or planning to become pregnant in the next 6 months
• People with severe kidney disease or kidney failure requiring dialysis, or with a kidney filtration rate (GFR or eGFR) below 30 mL/min
• People with certain other health conditions or circumstances that the investigator believes could make it unsafe or difficult to complete the study, which may include active substance use disorder, heavy ongoing use of opioids or benzodiazepines, unstable heart disease, a history of heart attack or certain heart procedures in the past 12 months, known dangerous heart rhythm problems or severe congenital heart disease, severe heart failure, a stroke or mini-stroke (TIA) in the past 12 months, untreated or poorly managed mental illness, untreated or poorly managed eating disorders in the past 2 years, or a history of deliberately misusing insulin
• People who plan to travel outside the United States and its territories for more than four consecutive weeks during the study
• People who plan to be without internet, video, or phone access for more than one consecutive week during the study
• People employed by Beta Bionics, people whose immediate family members work for Beta Bionics, people directly involved in running this trial, or people whose direct work supervisor or a first-degree relative is directly involved in running this trial
• People who have previously used the iLet device for more than four weeks in total (including the commercially available version or in a previous research study)

Important: Always verify eligibility with the trial site directly before applying.