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BCG Vaccination for Type 1 Diabetes
Study Summary
This trial is testing whether or not repeat vaccinations of BCG can help to sustain the beneficial effects seen in the previous Phase I study in long term diabetics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently taking antibiotics.My average blood sugar level over the past 5 years has been either below 6.5% or above 8.5%.I have a history of tuberculosis or have been vaccinated against it.You have a history of developing keloids.You live with someone who has a weakened immune system or is at high risk for getting sick easily.I have had neuropathy, foot ulcers, amputations, or kidney disease.I have been on insulin since my type 1 diabetes diagnosis.I have conditions or have taken medications that increase my risk of infections.I am not on long-term steroids for any condition.I have tested positive for anti-GAD, except if my c-peptide level is below 10pmol/L.I have advanced diabetic eye disease that hasn't been treated with laser.Your c-peptide levels when fasting or after eating are between 5-200 pmol/L.I am currently taking more than 160 mg of aspirin daily or using NSAIDs every day.My kidney function is impaired (creatinine > 1.5mg/dL).Your blood count is within the normal range.You are not pregnant (for females).I am between 18 and 65 years old.You do not have HIV.I have a chronic infectious disease like HIV or hepatitis.
- Group 1: Saline injection
- Group 2: Bacillus Calmette-Guérin
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is eligibility for this trial limited to individuals under the age of twenty?
"As per the trial's inclusion criteria, only those aged 18 to 65 are eligible. The number of studies for people younger than 18 is 355 and 1,819 studies exist for patients older than 65 years old."
Which individuals are most suitable to partake in this clinical trial?
"The medical trial is seeking to enroll 150 individuals with diabetes and autoimmune conditions aged 18-65. The primary eligibility criteria are a fasting or stimulated c-peptide between 5-200 pmol/L and age 18-65."
Are there any opportunities for individuals to enroll in this research endeavor?
"The data hosted on the clinicaltrials.gov webpage suggests that this trial is no longer accepting participants, having last been updated June 17th 2022 and initially being posted to the site 6/1/2015. Fortunately, there are 2,284 other medical studies actively seeking enrolment at present."
How hazardous is Bacillus Calmette-Guérin to human health?
"The safety of Bacillus Calmette-Guérin has been evaluated as a 2, given that it is only in the second phase of clinical trials and there are no data yet supporting its efficacy."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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