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BCG Vaccinations for Type 1 Diabetes
Study Summary
This trial will test if a second BCG vaccination can help kids with Type 1 diabetes by improving their immune and metabolic systems.
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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- My blood pressure is higher than what's typical for my age and sex.I haven't taken diabetes medication not listed in the criteria in the last 90 days.You have had keloid scars in the past.I have antibodies linked to diabetes.I am willing and able to take 3 insulin injections daily with meals during the trial.I have other health conditions that could worsen with treatment.I am currently taking more than 160 mg of aspirin daily or using NSAIDs every day.I have been diagnosed with a form of diabetes caused by a single gene.I have diabetes because of my cystic fibrosis.I often have very low blood sugar without noticing.I am between 12 and 18 years old and will be under 18 when the study starts.My average blood sugar level over the past 3 months was either below 7% or above 9%.I have diabetes without specific autoantibodies.Your current weight is either extremely low or extremely high for someone your height.I am pregnant, breastfeeding, planning to become pregnant, or not using birth control.I am not on antibiotics that affect BCG treatment.I was diagnosed with cancer within the last 5 years.I have a condition that affects the production or lifespan of my red blood cells.I have a chronic infectious disease like HIV or active hepatitis.I do not have severe neuropathy, heart attacks, active mental health issues, dementia, foot ulcers, major diabetes issues, amputations, or kidney disease.I have been vaccinated against TB or tested positive for TB exposure.I plan to start or change a medication soon that could affect my blood sugar levels.I have been a Type 1 diabetic for over 2 years and am on insulin.I use a daily insulin pump or injections for my diabetes.You don't have HIV, tuberculosis, or pregnancy.You have a history of frequently going to the hospital because you didn't follow medical advice for a condition called ketoacidosis.You were not born in the US or in a country where BCG vaccinations are required.I have had active eye disease due to diabetes.I am taking or plan to take oral medication for type 2 diabetes.My blood tests are normal, except for a slight increase in creatinine.I have been in a trial for Type 1 Diabetes treatment before.Your C-peptide level is between 1.5 pmol/L and 300 pmol/L.Your body temperature is higher than 98.6 degrees Fahrenheit.Your heart beats too fast or too slow.I am currently on high dose steroids or might need them soon.I have a history of tuberculosis or a positive TB blood test.I was diagnosed with type 1 diabetes according to WHO/ADA guidelines.I have chronic kidney issues or significant diabetes complications.I live with someone who has a weak immune system or is at high risk for infections.I've been hospitalized more than once for diabetic ketoacidosis in the last 3 months.I was diagnosed with diabetes before turning 1 year old.You are currently in another clinical trial testing a new treatment for diabetes.I have type 2 diabetes or severe obesity.I have a history of lupus.
- Group 1: Bacillus Calmette-Guérin
- Group 2: Saline Injection
- 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
Has the Food and Drug Administration authorized Bacillus Calmette-Guérin for medical use?
"In order to assess the safety of Bacillus Calmette-Guérin, our team at Power gave it a rating of 2 due to its Phase 2 trial status. This suggests that there is some evidence supporting security but none backing up efficacy claims."
How many participants can sign up for this trial in total?
"Affirmative. According to the clinicaltrials.gov, registration for this trial is open as of November 1st 2022 and began on March 22nd 2021. 150 participants need to be recruited from one medical centre in total."
Is this study open to individuals aged forty and above?
"This research study is accepting participants aged between 12 and 17 years."
Are further participants being recruited for this investigation?
"As per clinicaltrials.gov, this medical trial is still seeking participants and has been since March 22nd of 2022 - the date it was initially posted online. The research listing was last adjusted on November 1st, 2022."
What qualifications must potential participants of this trial possess?
"This clinical trial is actively recruiting 150 individuals, aged 12 to 17 years old, diagnosed with type 1 diabetes and/or autoimmune diseases. In order for patients to be eligible for the study they must meet multiple criteria including; normal CBC and chemistries readings, grade 1 creatinine elevations or lower, currently using CGM technology (and willing to continue use throughout the duration of the trial), HIV negative status verified by an antibody test, TB quantiFERON-TB test results should be negative,, hCG testing also required to be negative., detectable levels of c-peptide in between 1.5 pmol/L -"
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What portion of applicants met pre-screening criteria?
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