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 clinically diagnosed with type 1 diabetes (based on World Health Organization criteria) for at least one year
• People who have been using insulin for at least six months
• People aged 18 to 40 years old
• People whose HbA1c (a measure of average blood sugar over time) is below 10.5%
• People whose body mass index (BMI) falls between 18 and 30
• People whose blood pressure is below 140/90 mmHg
• Women who are not currently pregnant or breastfeeding
• Women who are sexually active and willing to use contraception throughout the study, and who test negative for pregnancy before starting; note that participants who become pregnant during the study, or who plan to become pregnant within the study timeframe, would be withdrawn
• People who use an insulin pump or multiple daily injections and who consistently use set insulin dosing calculations (such as carbohydrate ratios and correction factors); pump users must have a history of entering this information into their pump
• People willing to stop using their own continuous glucose monitor (CGM) for the duration of the trial once the study-provided CGM is in place
• People who have internet access and are willing to upload study data as required, including data from before the study begins
• People who currently use a downloadable blood glucose meter, or who are willing to use one provided by the study
• People whom the investigator is confident can correctly operate all study devices and follow the study protocol
• People willing to use only lispro (Humalog) or aspart (Novolog) insulin and no other insulin type during the study
• People whose total daily insulin dose is at least 10 units per day
• People willing not to start any new non-insulin blood sugar–lowering medications during the trial

Who may not be able to join:

• People who had a severe hypoglycaemic episode (very low blood sugar) causing a seizure or loss of consciousness in the past 12 months
• People who were diagnosed with diabetic ketoacidosis (a serious diabetes complication) in the past 12 months
• People who have previously been diagnosed with heart disease (such as a heart attack or heart failure)
• People who had a stroke in the past 12 months
• People with uncontrolled high blood pressure at rest
• People with conditions that would make it difficult to use a CGM (for example, blindness, severe arthritis, or limited mobility)
• People currently using steroid medications taken by mouth or inhaled, or other medications that the investigator determines would make participation unsafe
• People currently using any non-insulin blood sugar–lowering medication (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, or sulfonylureas)
• People with haemophilia or any other bleeding disorder
• People currently receiving treatment for a seizure disorder
• People with a medical condition or taking a medication that the investigator believes would put the participant or the study at risk
• People who currently smoke or who stopped smoking less than two years ago
• People whose screening heart tracing (ECG) shows signs of irregular heart rhythm, sinus node disease, or reduced blood flow to the heart
• Women with a haemoglobin level below 11 g/dL, or men with a haemoglobin level below 12 g/dL, found on screening blood tests
• People who have previously had an allergic reaction (such as anaphylaxis or severe swelling) to intravenous regular insulin
• People diagnosed with peripheral neuropathy (nerve damage assessed by a foot sensation test), significant levels of protein in the urine indicating kidney damage, or more than mild diabetic eye disease
• People whose doses of certain heart or blood pressure medications have been adjusted within the four weeks before enrolling in the study
• People who have previously had an allergic reaction to Definity microbubble infusion (a contrast agent used in some medical imaging)
• People currently enrolled in another clinical trial, unless both study investigators approve the overlap, or unless the other trial is a non-interventional registry study

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