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Intervention Arm for Type 1 Diabetes
Study Summary
This trial will test a new insulin system called the Omnipod 5. Subjects will use it for 14 days and then either continue using it for 90 days or go back to their regular insulin pump. Data will be collected throughout.
Timeline
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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- You have experienced very low blood sugar levels in the past 6 months.You have a medical condition, like untreated cancer, unstable heart disease, or severe kidney failure, that could make participating in the study risky for your health.You have experienced a severe complication called diabetic ketoacidosis (DKA) within the past 6 months, not caused by another illness or problems with your insulin pump.
- Group 1: Intervention Arm
- Group 2: Control Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many sites are actively participating in this experimental research?
"The University of Washington in Seattle, the Sansum Diabetes Research Institute in Santa Barbara and Joslin Diabetes Center based out of Boston are three sites actively recruiting patients. Additionally, there are 4 other clinical trial locations that have been approved to take part in this medical study."
What criteria must individuals meet to be eligible for this experiment?
"This clinical trial seeks 200 individuals aged between 18 and 70 that suffer from diabetes and/or autoimmune diseases. Additional criteria includes: a point-of-care A1C measure of 7.0 - 11.0%, three months experience with pump therapy, the ability to safely use study devices, access to a compatible smartphone for downloading the Dexcom app, the willingness to wear system continuously throughout study period, and signing an Informed Consent Form (ICF)."
What is the current enrollment number for this trial?
"In total, 200 patients who are suitable for the clinical trial must be recruited. The study sponsor is Insulet Corporation and will take place at two sites - University of Washington in Seattle, WA and Sansum Diabetes Research Institute in Santa Barbara, CA."
Is a minimum age requirement precluding those younger than 50 from participating in this research?
"The eligibilty requirements for this medical experiment stipulate that the minimum age of participants is 18, while those over 70 are excluded."
Is recruitment for this medical experiment still underway?
"According to data hosted on clinicaltrials.gov, this investigation is actively seeking participants with the trial having been initially posted on July 7th 2022 and most recently updated September 8th 2022."
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