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New treatment option for Brittle Type 1 Diabetes Mellitus
Official title Allogeneic Regenerative Islet Transplantation for the Treatment of Brittle Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT06196996
What this study is testing
- What it's testing
- This is a single-center, single-arm Phase Investigational Intervention Trial (IIT) clinical trial aimed at evaluating the safety and efficacy of allogeneic regenerative islet transplantation for the treatment of brittle type 1 diabetes mellitus. Eighteen patients with brittle type 1 diabetes mellitus, who have inadequate blood glucose control despite intensified exogenous insulin therapy, will be enrolled.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 65
You may be able to join if
- Age 6-65 years, gender not specified.
- Despite intensified exogenous insulin therapy, blood glucose control remains inadequate [glycated hemoglobin ≥7.5%, or TIR (time in range) \<70%].
- Able and willing to use the blood glucose meter provided by the sponsor, conduct self-blood glucose monitoring as required, and complete the patient...
- Fertile eligible people (male or female) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) during the...
- Diagnosed with type 1 diabetes for at least 1 year based on the World Health Organization (WHO) disease diagnostic criteria, and at least one...
You likely can't join if
- Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive human immunodeficiency...
- Presence of significant organic lesions in vital organs such as the heart, lungs, or brain;
- Complications of severe diabetes, including but not limited to retinal hemorrhage, diabetic foot, etc.;
- Liver function tests with total bilirubin, ALT, and AST ≥2×ULN, and failure to normalize after drug treatment;
- Untreated cancer or less than 1 year since cure;
- Severe gastrointestinal dysfunction, gastrointestinal immune diseases, and inability to take immunosuppressant;
See the full eligibility criteria
- Age 6-65 years, gender not specified.
- Despite intensified exogenous insulin therapy, blood glucose control remains inadequate [glycated hemoglobin ≥7.5%, or TIR (time in range) \<70%].
- Able and willing to use the blood glucose meter provided by the sponsor, conduct self-blood glucose monitoring as required, and complete the patient log as instructed.
- Fertile eligible people (male or female) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose; premenopausal female...
- Diagnosed with type 1 diabetes for at least 1 year based on the World Health Organization (WHO) disease diagnostic criteria, and at least one positive result for diabetes-related autoantibodies [glutamic acid...
- Voluntarily participate and sign the informed consent form.
- Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive human immunodeficiency virus (HIV) testing, and positive syphilis treponemal antibody (TP);
- Presence of significant organic lesions in vital organs such as the heart, lungs, or brain;
- Complications of severe diabetes, including but not limited to retinal hemorrhage, diabetic foot, etc.;
- Liver function tests with total bilirubin, ALT, and AST ≥2×ULN, and failure to normalize after drug treatment;
- Untreated cancer or less than 1 year since cure;
- Severe gastrointestinal dysfunction, gastrointestinal immune diseases, and inability to take immunosuppressant;
- History of smoking, alcohol abuse, or drug misuse;
- Severe mental or psychological disorders;
- Various advanced metabolic diseases (such as hyperuricemia, etc.);
- Participation in other clinical trials in the 3 months prior to enrollment;
- Patients requiring long-term oral/intravenous administration of high-dose glucocorticoids due to various diseases;
- Pregnant or lactating women;
- Investigator judgment indicating clear evidence of severe, active, uncontrolled endocrine or autoimmune abnormalities other than type 1 diabetes;
- Other situations judged by the investigator as unsuitable for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.