Phase 2 Type 1 Diabetes Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 84 years old.
• You have Type 1 diabetes.
• Your daily insulin dose is at least 0.5 units per kilogram of your body weight, or your BMI is 25 or higher.
• You are already using a continuous glucose monitor (a device that tracks your blood sugar throughout the day), or you are willing to wear one for the whole trial.
• You have been diagnosed with heart failure, or you are considered at high risk for heart failure based on specific blood test results, a previous hospital stay for heart failure, or certain heart scan measurements taken in the last 2 years (confirm with trial site).
• Your heart failure symptoms are rated as moderate to severe on a standard scale called the New York Heart Association Class II–IV (confirm with trial site).
• Your heart failure is affecting your quality of life in a measurable way, based on a questionnaire called the Kansas City Cardiomyopathy questionnaire (confirm with trial site).

Who may not be able to join:

• You have had heart surgery, a heart attack, a heart device fitted (such as a pacemaker), or heart mechanical support within the last month, or this is planned during the trial.
• You currently need a mechanical device to support your heart function because your heart failure is very advanced.
• Your heart failure is mainly caused by a serious heart valve problem, a condition called amyloidosis, or a thickened heart muscle condition called hypertrophic cardiomyopathy.
• Your main reason for feeling breathless is a lung or breathing condition, rather than heart failure.
• Your kidneys are not working well enough, based on a specific blood test result at the time of screening (confirm with trial site).
• You have moderate or severe liver disease at the time of screening.
• You have taken a type of diabetes medication called an SGLT2 inhibitor (such as dapagliflozin, empagliflozin, or sotagliflozin) within the last month.
• You have previously had a bad reaction or intolerance to SGLT2 inhibitor medications.
• You have a cancer diagnosis where your life expectancy is less than one year.
• You have had a severe low blood sugar episode (one that needed hospital treatment or help from another person) within the last month.
• You have had a serious diabetes complication called diabetic ketoacidosis or a hyperosmolar state within the last month, or two or more such episodes in the last 6 months.
• You are currently pregnant or breastfeeding.
• You are a woman who could become pregnant, or a man whose partner could become pregnant, and you are not using an acceptable form of contraception (confirm with trial site for what is considered acceptable).
• You are currently following a ketogenic (very low carbohydrate) diet.
• You are unwilling or unable to share your blood sugar and ketone monitoring data with the trial team.
• You have taken part in another clinical drug trial recently and the drug has not yet fully cleared from your body, or it has been fewer than 30 days since your last dose.

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