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 with Type 1 diabetes (T1D) who are aged 7 to 85 years, or people with insulin-requiring Type 2 diabetes (T2D) who are aged 18 to 85 years.
• People who have had a confirmed diagnosis of T1D for at least 6 months, or insulin-requiring T2D for at least 1 year, as shown in their medical records.
• People who are willing to give their consent to take part (or, for children, a parent or caregiver who is able to give consent on their behalf).
• People (or their parent/caregiver) who can read English or Spanish, as the study materials and pump are available in those languages only.
• People who are willing to wear the study device continuously throughout the trial.
• People who have had a retinal (eye) examination on record that meets the timing requirements for their age and diabetes type, as set out by the American Diabetes Association (confirm with trial site for the specific timing that applies).
• People who are willing to regularly upload their pump data using an app or computer.
• People who are willing and financially able to use one of the specific insulin types listed in the study, including brands such as Humalog, NovoLog, NovoRapid, Admelog, Fiasp, Lyumjev, and others (confirm with trial site for the full list and any biosimilar options).

Who may not be able to join:

• People who are unable to give informed consent due to a mental or intellectual disability.
• People who have had 2 or more severe low blood sugar episodes in the past 6 months that required emergency medical help, caused a coma, or resulted in a seizure.
• People who have had 1 or more episodes of diabetic ketoacidosis (a serious diabetes complication) in the past 6 months.
• People with T2D who have had a condition called hyperglycemic hyperosmolar syndrome (HHS) in the past 6 months.
• People with an active, unresolved skin condition in the area where the sensor or infusion set would be placed, such as psoriasis, a rash, or a skin infection.
• People who are currently pregnant or planning to become pregnant during the study period; a negative pregnancy test will be required for women of childbearing age at screening.
• People with an inadequately treated thyroid condition (either underactive or overactive), at the trial doctor's discretion.
• People who have been diagnosed with adrenal insufficiency (a condition where the adrenal glands do not produce enough hormones).
• People who have taken steroid medications (oral, injected, or intravenous) within the past 8 weeks.
• People with T1D who are currently using blood sugar–lowering medications other than metformin or GLP-1/GIP medications (such as Mounjaro), within the past 8 weeks.
• People with T2D who are currently using blood sugar–lowering medications other than metformin, GLP-1/GIP medications, or SGLT2 inhibitors, within the past 8 weeks.
• People who have used sulfonylurea or meglitinide medications (a type of diabetes tablet, e.g., repaglinide) in the past 8 weeks.
• People who have used inhaled insulin in the past 8 weeks.
• People who are currently using or planning to use hydroxyurea (a medication used for certain blood conditions and cancers) during the study.
• People who are currently taking part in another medical drug or device trial, or have done so within the past 2 weeks.
• People whom the trial doctor considers to be misusing drugs or alcohol.
• People whom the trial doctor considers unable to safely complete all study procedures.
• People with a level of visual impairment that would prevent them from safely taking part in the study, even with the help of a caregiver, as determined by the trial doctor.
• People who have planned elective surgery requiring general anaesthesia during the study period.
• People with sickle cell disease or other inherited blood (haemoglobin) conditions, or who have received a red blood cell transfusion or erythropoietin treatment within the past 3 months.
• People who plan to receive a red blood cell transfusion or erythropoietin treatment during the study.
• People currently diagnosed with an eating disorder such as anorexia or bulimia.
• People with a blood disorder within the past 3 months that the trial doctor believes could affect HbA1c (a measure of long-term blood sugar levels) test results.
• People who are on kidney dialysis.
• People with significantly reduced kidney function, specifically an eGFR (a kidney function measurement) below 30 (confirm with trial site).
• People with coeliac disease that is not adequately managed, as determined by the trial doctor.
• People who have had a major heart or stroke-related event within the past year, including heart attack, unstable chest pain, heart bypass surgery, coronary stenting, mini-stroke, stroke, heart failure, or serious heart rhythm problems.
• People who had any of the above heart or stroke-related events more than 1 year ago may also be excluded, at the trial doctor's discretion.
• Members of the research team working on this study.
• Medtronic Diabetes employees or their immediate family members (note: adult children and adult siblings are excluded from this restriction — confirm with trial site).

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