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:

• You are between 18 and 70 years old (male or female).
• You are able to give written consent and willing to follow the study procedures.
• You have Type 1 diabetes that started before age 40, have been on insulin for at least 5 years, have very little to no natural insulin production (confirmed by a specific test), and have had at least one serious low blood sugar episode in the past year; OR you have a history of frequent or dangerous low blood sugar episodes, including ones linked to not feeling the warning signs, extreme blood sugar swings, or significant fear around low blood sugar.
• You are actively managing your diabetes with close monitoring — checking your blood sugar at least 3 times a day on average, taking 3 or more insulin injections daily or using an insulin pump, and being overseen by a diabetes specialist who has seen you at least 3 times in the past year.
• You have reduced ability to feel low blood sugar (measured by specific scoring tools called the Clarke score and HYPO score), OR you have very unstable blood sugar levels despite doing your best to manage them (measured by a tool called the Lability Index score), OR a combination of moderate results across all three of these measures (confirm with trial site for exact score thresholds).

Who may not be able to join:

• Your Body Mass Index (BMI) is above 30, or you weigh less than 50 kg (about 110 lbs).
• Your daily insulin needs are too high (more than 1 unit per kg of body weight per day) or too low (less than 15 units per day).
• You have untreated advanced eye disease related to diabetes affecting the blood vessels in your eyes.
• Your blood pressure is too high (top number above 160 or bottom number above 100).
• Your kidneys are not filtering blood well enough (based on a kidney function test below a certain level).
• You have or have had significant protein leakage in your urine, which is a sign of kidney damage.
• You have certain antibodies in your blood that could cause problems with transplanted tissue (confirm with trial site).
• You are pregnant, currently breastfeeding, wish to become pregnant at any point in the future — including after the study ends — or are unwilling to use effective birth control during the study and for 4 months after; this applies to both female and male participants (note: condoms alone are not considered acceptable contraception for this study).
• You currently have or have had an active infection, including Hepatitis B, Hepatitis C, HIV, or tuberculosis — even if you have no obvious symptoms but test results suggest infection.
• You have a known current problem with alcohol or drug misuse.
• You have serious existing heart disease.
• You have a condition that causes your blood to clot too easily.
• You have gallstones that are causing symptoms.
• You have or have had inflammation of the pancreas (either short-term or long-term).

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