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 aged 14 to 75 years (inclusive) at the time of signing consent
• People who have had a Type 1 diabetes diagnosis for at least 6 months, or a Type 2 diabetes diagnosis for at least 1 year, based on the doctor's judgment
• People who are currently using basal/bolus insulin through multiple daily injections or an insulin pump (with or without an automated system)
• People whose HbA1c blood sugar marker is 7.5% or above
• People who, on average, manually started fewer than 4 insulin doses per day over the 14 days before the screening visit (based on device records or self-report)
• People who, on average, manually started fewer than 4 insulin doses per day over 14 days during the standard therapy phase of the trial (based on device records or self-report)
• People who are currently using a continuous glucose monitor (CGM)
• People who are willing to use only specific U-100 insulin types during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev, or their generic equivalents
• People who are able and willing to supply their own insulin for the entire study period
• People whom the investigator considers appropriate to participate, and whom the investigator is confident can safely use all study devices and follow the study protocol (this also applies where a caregiver is involved)
• People taking non-insulin glucose-lowering medications (such as GLP-1 receptor agonists, SGLT2 inhibitors for Type 2 diabetes, or other types) or weight-reduction medications, where the dose has been stable for at least 6 weeks before screening, and who are willing to keep the dose unchanged unless safety requires otherwise
• People who are willing to wear the study system continuously throughout the entire trial
• People who are willing and able to sign the informed consent form, or who have a parent or guardian willing and able to sign it; adolescents under 18 years will also need to provide assent as required by local regulations
• People who can read, understand, and operate the study device in English
• People who are capable of becoming pregnant and are willing and able to undergo pregnancy testing

Who may not be able to join:

• People with any medical condition that the investigator considers would place them at an unacceptable safety risk
• People with a current or known history of unstable heart (coronary artery) disease, including unstable chest pain, chest pain that prevents moderate exercise despite treatment, or a history of heart attack, heart stent procedure, or bypass surgery within the 12 months before screening
• People who have any major surgery planned during the study period, as judged by the investigator
• People who have experienced a severe hypoglycaemic (very low blood sugar) episode in the past 6 months — defined as an episode that required another person's help due to confusion or physical impairment, and required someone else to give carbohydrates, glucagon, or other emergency treatment
• People who have had diabetic ketoacidosis (DKA) or a hyperosmolar hyperglycaemic state (a serious high blood sugar emergency) in the past 6 months, where the cause was not an intercurrent illness or pump failure
• People who cannot tolerate adhesive tape, or who have an unresolved skin condition in the area where the sensor or pump would be placed
• People who have had a blood disorder within 3 months before screening that, in the investigator's opinion, could affect the accuracy of the HbA1c test result
• People who are currently using the medication hydroxyurea
• People who plan to receive a blood transfusion at any point during the study
• People who have taken steroid medications by mouth or injection within 4 weeks before screening, had a local steroid injection (such as into a joint or the spine) within 1 week before screening, or who plan to take oral or injectable steroids during the study
• People with Type 1 diabetes who have taken non-insulin glucose-lowering medications other than metformin or GLP-1 medications in the 4 weeks before screening
• People with Type 2 diabetes who have taken sulfonylurea medications in the 4 weeks before screening
• People who are pregnant or breastfeeding, or who are capable of becoming pregnant and are not using an accepted form of contraception (accepted methods include abstinence, barrier methods such as condoms, hormonal contraceptives, an intrauterine device, surgical sterilisation such as tubal ligation or hysterectomy, or a vasectomised partner)
• People who have participated in another clinical study involving an investigational drug or device within the past 30 days, or who plan to join another study during this trial
• People who are unable to follow the study protocol for its full duration, or whom the investigator considers otherwise unsuitable for participation
• People who are an employee of Insulet, an investigator, a member of an investigator's study team, or an immediate family member of any of the above

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