Type 2 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 between 18 and 75 years old at the time they agree to join the trial.
• People who have been diagnosed with type 2 diabetes for at least 6 months before the screening visit.
• People who have been on insulin therapy for at least 3 months before screening, with no changes to their insulin routine in the 6 weeks before the study's baseline monitoring begins, and who have not used an automated insulin delivery system in the past 3 months.
• People whose insulin routine fits one of these patterns: multiple daily injections using a basal-bolus approach, a non-automated insulin pump, basal-plus-premix injections, or basal insulin only (without mealtime doses).
• People using basal insulin only whose HbA1c (a measure of average blood sugar over time) is at least 7.5% and below 14.0% at screening.
• People using basal-bolus insulin (all other regimens) whose HbA1c is at least 6.0% and below 14.0% at screening.
• People who are willing to use only specific types of U-100 rapid-acting insulin approved for use with the study pump (such as Humalog, Novolog, Admelog, Kirsty, Fiasp, Lyumjev, or their equivalents).
• People who are willing to use only the study-provided glucose sensor (Libre 2 Plus or 3 Plus) and no other sensor during the study.
• People who the investigator considers appropriate for insulin pump therapy, taking into account their history of blood sugar emergencies and other health conditions.
• People who are not expected to need to start any new non-insulin diabetes or weight-loss medications that lower blood sugar during the 26-week main study phase.
• People who are already taking non-insulin diabetes or weight-loss medications that lower blood sugar, where the dose has been stable for at least 6 weeks before baseline monitoring and is not expected to increase during the 26-week main study phase.
• People who the investigator is confident can safely use all study devices and follow the study requirements.
• People who are willing to wear the insulin pump system continuously throughout the 26-week study phase.
• People who are willing and able to sign the study consent form.
• People who can read and understand English.
• People who are able to become pregnant and are willing to undergo pregnancy testing as required.

Who may not be able to join:

• People who have used an automated insulin delivery pump in the 3 months before screening.
• People with a medical condition that the investigator considers an unacceptable safety risk, which may include untreated cancer, unstable heart disease, unstable or advanced kidney disease, unstable eye disease related to diabetes, or unstable mental health conditions such as eating disorders or substance misuse.
• People with coronary artery disease that is not well-managed with medication, including unstable chest pain despite treatment, or who have had a heart attack, coronary stent procedure, or heart bypass surgery within the 12 months before screening.
• People who have planned major surgery during the study period.
• People who have had more than one episode of severe low blood sugar (requiring another person's help due to loss of consciousness or altered awareness) in the past 6 months.
• People who have had more than one episode of diabetic ketoacidosis (a serious diabetes complication) or hyperosmolar hyperglycemic state in the past 6 months, where those episodes were not caused by illness, a blocked insulin line, or an initial diabetes diagnosis.
• People who cannot tolerate adhesive tape or who have a skin condition that would affect where the sensor or pump can be placed.
• People who have had a blood disorder in the 3 months before screening that the investigator believes could affect the accuracy of HbA1c results.
• People who plan to receive a blood transfusion during the 26-week study phase.
• People who are pregnant, breastfeeding, or capable of becoming pregnant and not using an accepted form of contraception (accepted methods include abstinence, condoms, hormonal contraceptives, an intrauterine device, surgical sterilisation, or having a vasectomised partner).
• People who have taken steroid tablets or injections in the 4 weeks before baseline monitoring, had a local steroid injection (such as into a joint or spine) within 1 week before baseline monitoring, or who plan to take oral or injectable steroids during the 26-week study phase.
• People who have participated in another clinical trial involving an experimental drug or device in the past 30 days, or who plan to join another interventional study during the 26-week study phase.
• People who the investigator does not believe will be able to follow the study requirements for the full duration.
• People who are employees of the study sponsor (Insulet), an investigator, a member of the study team, or an immediate family member of any of these individuals.

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