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 have been diagnosed with Type 1 or Type 2 diabetes for at least 6 months at the time of joining the trial.
• People with Type 1 diabetes who have been taking multiple daily insulin injections for at least 3 months before the screening visit, are willing to dose mealtime insulin based on time of day or meal size, and have been taking one long-acting (basal) insulin injection per day for at least one week before screening.
• People with Type 2 diabetes who either: have not used insulin in the past 3 months but the doctor determines they need to start a long-acting insulin routine; have been using only long-acting insulin for at least 3 months and taking one injection per day for at least one week before screening; or have been using multiple daily injections for at least 3 months, are willing to dose mealtime insulin by time of day or meal size, and have been taking one long-acting injection per day for at least one week before screening.
• People aged 18 to 80 years at the time of giving consent to participate.
• People whose HbA1c (a blood sugar average measurement) is above 7.5% and below 12% at screening.
• People who are only using injected insulin types that are listed in the study device's official instructions.
• People whose non-insulin diabetes medications have been at a stable dose for at least 4 weeks before screening, with no dose changes expected during the study (unless a reduction or stop is needed for safety).
• People whose weight-related medications have been at a stable dose for at least 4 weeks before screening, with no dose changes expected during the study (unless a reduction or stop is needed for safety).
• People who weigh between 80 and 440 pounds at the time of screening.
• People who are willing to use the FreeStyle Libre 3 (FSL 3) continuous glucose monitor (CGM) as directed by the manufacturer and avoid using any other personal CGM during the study.
• People who are willing to record their insulin doses, meals, and daily activities in the study's Diary mobile app.
• People who own a compatible smartphone — either an iPhone running iOS 17.0 or higher, or an Android phone running version 10.0 or higher — and are willing to install and use the required apps as instructed, with internet access available for at least one data upload per day.
• People whom the study doctor considers a suitable candidate for automated insulin guidance therapy.
• People whom the study doctor is confident have the mental ability to participate, operate all study devices, and follow the study rules.
• People with a sufficient understanding of written and spoken English to give informed consent and use the study apps effectively.
• Women who could become pregnant must be willing and able to undergo pregnancy testing.

Who may not be able to join:

• People who have used an insulin pump within 3 months before joining the trial.
• People who have used mixed insulin or intermediate-acting insulin (NPH) within 3 months before screening.
• People who have been taking more than 128 units of long-acting (basal) insulin per day, or more than 79 units in a single short-acting (bolus) insulin injection, in the 7 days before screening.
• People with a medical condition that the study doctor believes would put them at an unacceptable safety risk, such as untreated cancer, unstable heart disease, unstable or end-stage kidney disease, or an eating disorder such as anorexia or bulimia.
• People with coronary artery disease that is not stable with medication, unstable or exercise-limiting chest pain, or a history of heart attack, coronary stenting, or bypass surgery within the past 12 months.
• People who have any major surgery planned during the study period, in the study doctor's judgement.
• People who have had more than one severe low blood sugar (hypoglycaemic) episode in the 6 months before screening.
• People who have had diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic syndrome (HHS) in the 6 months before screening.
• People with a blood disorder within 3 months before screening that the study doctor believes could affect the accuracy of HbA1c results.
• People who have had a blood transfusion or donated blood in the 3 months before the study, or plan to do so during the study, as this can affect red blood cell measurements.
• People who have taken oral or injectable corticosteroids (steroid medicines) within 2 weeks before screening, or who plan to take them during the study.
• People whom the study doctor determines are unable to follow the study plan for any reason.
• Employees of DreaMed Diabetes, study investigators, members of the study team, or immediate family members (spouse, parent, child, sibling, or legal guardian) of any of those people.
• People who have taken part in another clinical study involving an experimental drug or device within 90 days before screening, or who plan to do so during the study.
• People who are pregnant, breastfeeding, planning to become pregnant during the study, or — for women who could become pregnant — are not using an acceptable form of contraception (acceptable forms include abstinence, condoms, oral or injectable contraceptives, an IUD, or a hormonal implant). Women of childbearing potential are defined as those who have begun menstruating and have not had a surgical sterilisation or been post-menopausal for more than 12 months (confirm with trial site).
• People who cannot tolerate adhesive tape, or who have an unresolved skin condition that could interfere with wearing the CGM sensor.

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