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MiniMed™ 780G System for Type 2 Diabetes
Study Summary
This trial is testing the MiniMed 780G system on adults with type 2 diabetes who require insulin. The study will last approximately 135 days, and at the end, subjects will be able to keep using the system.
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.Side effects data
From 2016 Phase 4 trial • 85 Patients • NCT01970241Trial Design
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- I have sickle cell, a blood disorder, or received a blood transfusion or erythropoietin recently.I am between 18 and 80 years old.I have been on a specific insulin regimen or pump therapy for at least 3 months.I am scheduled for surgery that needs general anesthesia during the study.I plan to try for a pregnancy during the study.Your HbA1c blood test must be done at a lab certified by the National Glycohemoglobin Standardization Program (NGSP) and follow their standards.My daily medication dose is either below 8 units or above 250 units.I have been on a stable insulin regimen for at least 3 months.Your HbA1c level is less than 10% when tested at the screening visit.I am a woman who can have children and am not using birth control.I was hospitalized or visited the ER for uncontrolled diabetes in the last 6 months.Your HbA1c level is less than 10%.I have been diagnosed with an eating disorder like anorexia or bulimia.I haven't used steroids in the last 8 weeks and don't plan to during the study.I am currently using hydroxyurea or plan to use it during the study.I have chronic kidney disease with chronic anemia.I have been diagnosed with type 2 diabetes for at least 2 years.I am willing and able to use and pay for the specified insulin for the study.I've had 2 or more severe low blood sugar episodes needing medical help in the last 6 months.I am a woman who can have children and my pregnancy test was positive.I have been diagnosed with adrenal insufficiency.I have celiac disease that has not been treated.I haven't had diabetic ketoacidosis or severe hyperglycemia in the last 6 months.I am currently being treated for an overactive thyroid.I plan to get a red blood cell transfusion or take erythropoietin during the study.I am between 18 and 80 years old.I am currently on dialysis.I tested positive for GAD antibodies.I can make my own medical decisions without needing a legal guardian.
- Group 1: MiniMed 780G System
- 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
Are individuals still able to apply for this research initiative?
"Indeed, clinicaltrials.gov demonstrates that this investigation is currently recruiting participants. It was first published on February 25th 2022 and the latest changes were made August 5th 20202. The trial requires 300 individuals from 11 clinics to participate in its research."
To whom is this clinical trial open for enrollment?
"This clinical trial is recruiting 300 participants of ages 18 to 80 who are diagnosed with diabetes mellitus. In order to be considered, applicants must not require a representative for consent due to intellectual or mental limitations and have been on an MDI regimen (basal/bolus insulin injections) for at least three months prior. Additionally, the applicant needs to demonstrate their ability to use technology properly, willingness perform fingerstick blood glucose measurements when requested, wear the system throughout the study period and possess HbA1c levels below 10% as determined by Central Lab testing that follows NGSP standards. Lastly, TSH should be within normal reference range"
Is the elderly demographic being enlisted for participation in this research?
"This clinical trial has a narrow age range with all participants falling between 18 to 80 years old. Those below the age of consent have access to 193 separate studies, while those above 65 can join 1068 different trials."
What is the uppermost threshold for participant enrollment in this clinical investigation?
"Affirmative, the details on clinicaltrials.gov confirm that this trial is actively accepting patients. It was initially posted on February 25th 2022 and most recently updated August 5th. The research team need to recruit 300 participants from 11 different sites."
Are there multiple medical centers that have implemented this trial in North America?
"At this time, the trial is being conducted in 11 medical centres spread across Jacksonville, Canton and Macon as well as other cities. When selecting a location to participate from it is prudent to choose the closest one available to reduce travel expenses associated with enrollment."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- East Coast Institute for Research: < 48 hours
Average response time
- < 2 Days
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