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:

• People with a clinical diagnosis of Type 1 diabetes that started before age 35, who needed insulin treatment within 1 year of being diagnosed — or, if diagnosed after age 35, who have had a positive autoantibody blood test linked to Type 1 diabetes (past or present)
• People whose HbA1c (a measure of average blood sugar over roughly 3 months) is between 6.0% and 10.0%
• People willing to wear a continuous glucose monitor (CGM) provided by the study and share the data through a cloud system
• People who have had a Type 1 diabetes diagnosis for at least 1 year at the time of screening
• People with a C-peptide level (a measure of the body's remaining insulin production) of at least 100 pmol/L (or 0.3 ng/mL) from a fasting or non-fasting blood test taken during or before screening
• People with a BMI of 35 or below
• People whose kidneys are functioning above a certain level, measured by an eGFR greater than 45 ml/min/1.73m²
• People who are able and willing to follow the study requirements for the full duration of the trial
• People who have provided written informed consent before any study-related assessments take place

Who may not be able to join:

• People diagnosed with monogenic diabetes, Type 2 diabetes, or diabetes caused by removal of the pancreas
• People who have had more than one episode of severe (Level 3) hypoglycaemia (very low blood sugar requiring assistance from another person) in the past 6 months
• People with a significant heart history, including heart attack, coronary procedures, valve disease or repair, unstable angina, mini-stroke, or stroke within the 6 months before the study
• People with advanced heart failure (classified as New York Heart Association Stage III or IV)
• People with uncontrolled high blood pressure (systolic above 160 mmHg and/or diastolic above 100 mmHg)
• People with symptoms of low blood pressure when standing up
• People currently taking steroid medications (except low replacement doses for adrenal conditions) or other medicines that affect how the body responds to insulin
• People who have used non-insulin diabetes medications within the past 30 days
• People with a significant history of serious or unstable conditions affecting the nervous system, liver, kidneys, blood, lungs, heart, digestive system, or urinary system — including anyone who has had a previous organ or cell transplant
• People with a history of cancer (other than certain treated skin cancers, or treated cervical pre-cancer) that has not been in full remission for at least 5 years before screening
• People with known recreational substance use or a psychiatric condition that, in the investigator's opinion, could affect safety or ability to attend scheduled visits
• People with a history of alcohol or drug misuse or addiction in the past 12 months
• Women of childbearing age who have a positive pregnancy blood test, or women who are breastfeeding
• People who are unwilling to use an effective method of contraception during the study — including male participants who are required to use a condom or abstain from intercourse and avoid sperm donation, and female participants who are required to be surgically sterile, post-menopausal, or using an accepted barrier contraception method such as an IUD, barrier methods with spermicide, or abstinence

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