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MiniMed 780G System for Type 1 Diabetes
Study Summary
This trial will study the safety and effectiveness of a new insulin pump in people with type 1 diabetes.
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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- I am between 2 and 6 years old and have been diagnosed with type 1 diabetes for at least 6 months.You have a history of vision problems that would prevent you from safely taking part in the study.I have taken certain medications recently.I have skin issues where a medical sensor would be placed.I use between 8 and 250 units of insulin daily.I have not had recent major heart problems.I am between 2 and 80 years old.I have been diagnosed with type 1 diabetes.My celiac disease is not well-managed according to my doctor.I had a heart problem over a year ago and haven't been cleared by a doctor since.I have been using a pump for my condition for over 6 months.You cannot handle having tape on the area where the sensor will be placed, as determined by a qualified person.I am currently receiving treatment for an overactive thyroid.I can make my own medical decisions.You are currently using illegal drugs, marijuana, prescription drugs, or alcohol excessively.I am currently taking certain medications.You have three or more heart disease risk factors and have not had a normal EKG within a certain time frame.I am willing to use Fiasp insulin provided for the study.I have been diagnosed with adrenal insufficiency.I have a planned surgery that will need general anesthesia during the study.I am currently receiving dialysis.I have had severe low blood sugar or my diabetes is not well-controlled recently.You are allergic to insulin aspart or any of the ingredients in Fiasp.I am willing and able to use and pay for the required insulin types.I am between 7 and 13 years old and have been diagnosed with type 1 diabetes for over a year.You have used a MiniMed 780G pump before the screening.I am a woman who could get pregnant and am not using birth control.I am a woman who can have children and my pregnancy test was positive.I am a woman and plan to become pregnant during the study.I am between 7 and 80 years old.I am currently using hydroxyurea or plan to use it during the study.Your thyroid-stimulating hormone (TSH) levels are in the normal range, or if they are not, your Free T3 levels are within the lab's reference range and your Free T4 levels are also within the normal range.Your HbA1c level is less than 10% when you are checked before the study.I am between 14 and 80 years old and have been diagnosed with type 1 diabetes for at least 2 years.I can make my own medical decisions.I am willing to use Fiasp insulin provided for the study.
- Group 1: MiniMed 780G System Utilizing Insulin Fiasp
- 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
Could minors be included in the parameters of this clinical experiment?
"This research project has a range for enrollment, stipulating that participants must be older than 7 but younger than 80 to qualify."
How many medical facilities have been approved to administer this experiment?
"Currently, the trial is recruiting from 15 different sites such as Alberta Children's Hospital Research Institute in Calgary, Valley Research in Fresno and Barbara Davis Center for Diabetes in Aurora. An additional dozen medical centres are also included."
How many individuals are being considered for inclusion in this clinical experiment?
"To carry out the study, 250 suitable candidates must be identified and enrolled. Medtronic Diabetes is organizing this trial from multiple sites including Alberta Children's Hospital Research Institute in Calgary and Valley Research in Fresno, California."
Does my profile meet the criteria to join this research endeavor?
"This clinical trial is currently accepting 250 participants with a diagnosis of type 1 diabetes, between the ages of two and eighty. To be eligible for enrolment, individuals must meet certain conditions, such as having a minimum daily insulin requirement (Total Daily Dose) above 8 units; being literate in one of the languages offered by the pump system; and consenting to fingerstick blood glucose measurements when necessary. Furthermore, those aged fourteen to eighty are required to have had their medical condition diagnosed at least two years prior, while minors aged seven through thirteen need only demonstrate that they have lived with type 1 diabetes since before turning seven. Finally, any"
Are there opportunities still available to participate in the trial?
"Per the information provided on clinicaltrials.gov, this is an ongoing trial with a start date of March 17th 2022 and its most recent update occurring on October 26th 2022."
What objectives are being sought after during this research?
"Within the 3 month trial period, the primary safety outcome to be assessed is a change in HbA1c. Secondary endpoints include evaluating mean percent of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) and hypoglycemia (< 54 mg/dL [3.0 mmol/L]), for both age 7-17 and 18-80 groups respectively, with tests assessing superiority or noninferiority as appropriate."
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