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 2 to 70 years old at the time of signing the consent form
• People who have had a Type 1 diabetes diagnosis for at least 6 months (or at least 3 months for children aged 2 to 7 years), based on the study doctor's assessment
• People who currently use a basal/bolus insulin approach, either through multiple daily injections or an insulin pump (with or without an automated system)
• People who are willing to use one of the specified fast-acting insulins during the study: Humalog U-100, Novorapid, or their approved equivalents
• People who the study doctor considers appropriate for insulin pump therapy, taking into account their history of serious low or high blood sugar episodes and any other health conditions
• People who are taking non-insulin diabetes medications or weight management medications, where the dose has been unchanged for at least 6 weeks before the screening visit, and who are willing to keep the dose stable unless a safety concern requires a change
• People who the study doctor is confident can safely use all the study devices and follow the study requirements
• People who are willing to wear the study device continuously throughout the trial
• People (or their parent or guardian, for younger participants) who are willing and able to sign the consent form, with additional agreement obtained from child participants as required by local rules
• People who can read and understand English
• People who are capable of becoming pregnant and who are willing and able to undergo pregnancy testing as required

Who may not be able to join:

• People with a medical condition that the study doctor believes would pose an unacceptable safety risk, which may include untreated cancer, unstable heart disease, unstable or severe kidney disease, unstable eye disease related to diabetes, or unstable mental health conditions such as eating disorders or substance misuse
• People with a current or known history of unstable coronary artery disease, including unstable chest pain, or who have had a heart attack, certain heart procedures, or heart rhythm problems requiring treatment within the 12 months before screening
• People who have major surgery planned during the study period, in the study doctor's opinion
• People who have had more than one severe low blood sugar episode in the past 6 months, where a severe episode means losing enough awareness to need another person to give them sugar, glucagon, or other emergency help
• People who have had more than one episode of diabetic ketoacidosis (a serious diabetes complication) in the past 6 months, not explained by illness, a blocked or dislodged cannula, or a new diabetes diagnosis; or people who are unable to tolerate adhesive tape or have an unresolved skin condition that could affect where the sensor or pump is placed (confirm with trial site)
• People who have had a blood disorder within the 3 months before screening that the study doctor believes could affect the accuracy of a key blood sugar test (HbA1c)
• People currently using a medication called hydroxyurea
• People who plan to receive a blood transfusion during the study
• People who have taken steroid tablets or injections in the 4 weeks before screening, had a local steroid injection (such as into a joint or spine) in the week before screening, or who plan to take steroids during the study
• People who have been using non-insulin diabetes medications or weight loss medications other than metformin and/or a GLP-1 medication 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 (such as abstinence, condoms, hormonal contraception, an intrauterine device, surgical sterilisation, or a vasectomised partner)
• People who have taken part in another clinical study involving an investigational drug or device in the past 30 days that may have affected their diabetes management, or who plan to join another interventional clinical study during this trial
• People who the study doctor believes are unable to follow the study requirements for its full duration, or are otherwise not suitable to participate
• People who are employed by the device manufacturer (Insulet), or who are a study investigator, a member of the study team, or an immediate family member of any of those individuals

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