Your session is about to expire
← Back to Search
MiniMed 780G System for Type 1 Diabetes
Study Summary
This trial will study the safety of using Lyumjev insulin lispro to treat type 1 diabetes in children and adults at home.
- Type 1 Diabetes
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- You are willing to participate in the study.You are between 2 and 80 years old when you are checked to see if you can join the study.You have had type 1 diabetes for at least 2 years if you are 14-80 years old, or for at least 1 year if you are 7-13 years old.Your hematocrit level is lower than the normal range.You are currently receiving dialysis treatment.You do not have a legally authorized representative to consent on your behalf due to mental or intellectual disability.You must be between 7 and 80 years old when you are checked to see if you can join the study.You are planning to receive a blood transfusion or erythropoietin during the study.You currently have an eating disorder like anorexia or bulimia.You have long-term kidney disease that causes ongoing anemia.Your blood test shows that your creatinine level is higher than 2 mg/dL.You are allergic to insulin lispro or any ingredients in Lyumjev®.You had a serious condition called diabetic ketoacidosis within the last 6 months before being checked for this study.You are currently receiving treatment for hyperthyroidism.You are currently using illegal drugs, marijuana, prescription drugs, or alcohol excessively.You have a history of eye problems that might make it unsafe for you to take part in the study or do all the required tests.You have had 2 or more severe low blood sugar episodes that required medical help, caused a coma, or seizures in the last 6 months.You have a skin problem where the sensor needs to be placed, and it hasn't been treated yet.Your HbA1c level is less than 10% at the time of screening.You are currently taking certain medications for diabetes, such as pramlintide, DPP-4 inhibitors, liraglutide, metformin, or canagliflozin.You need to take at least 8 units of insulin per day, but no more than 250 units per day.You have celiac disease that is not well managed with treatment.You have three or more heart health risk factors and have not had a normal EKG test within the past 6 months or approval from a doctor.You have used a MiniMed 780G pump before the screening.You have been diagnosed with adrenal insufficiency.You are currently taking or planning to take hydroxyurea during the study.You have sickle cell disease, a certain type of blood disorder, or have had a blood transfusion or certain medication within the last 3 months.You have taken any form of steroids by mouth, injection, or IV in the past 8 weeks, or plan to take any during the study.You need to take at least 8 units of insulin every day.Your thyroid-stimulating hormone (TSH) level is normal, or if it's not, your Free T3 is within a certain range and your Free T4 is normal.You have been using a pump therapy for more than 6 months before the screening.
- Group 1: MiniMed 780G System Utilizing Insulin Lyumjev®
- 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
Is there a significant presence of this experiment occurring within U.S. borders?
"Endocrine Research Solutions in Roswell, Georgia as well as Diabetes and Glandular Disease Clinic, P.A located in San Antonio, Texas are two of the 20+ sites that are accepting patients for this trial. The Barbara Davis Center for Childhood Diabetes based out of Aurora Colorado is also partaking in recruitment efforts."
What purpose does this medical experiment aim to fulfill?
"This medical trial will assess its primary outcome - the percentage of time in range (TIR 70-180 mg/dL) for 7-17 year olds over a period of 3 months. Secondary outcomes include: % of time in hypoglycemia (< 54 mg/dL) for ages 2 to 17 with non-inferiority tests, and % of time in hypoglycemia (< 54 mg/dL) for 18 to 80 year olds with superiority tests."
What is the sample size for this experiment?
"Affirmative. Supporting information on clinicaltrials.gov declares that recruitment for this experiment, initiated 5/5/2022 and recently modified 11/2/2022, is still in progress with a requirement of 250 participants at 20 distinct sites."
Does the current research trial include participants over 25 years of age?
"Participants for this research must be of at least 7 years in age and no more than 80."
Which patient demographics qualify for participation in this trial?
"This research study is searching for 250 people with type 1 diabetes mellitus between the ages of two and eighty. To apply, one must meet a plethora of qualifications: they should be 2-80 years old at screening; 14-80 age group requires a clinical diagnosis of T1D lasting two or more years made by an authorised clinician; 7-13 year olds need to have been diagnosed for over 12 months; those in the 2-6 cohort are required to have had T1DM for 6 months minimum, not require a legal representative due to mental disability, possess sufficient literacy levels to comprehend pump materials, consent willingly without coercion,"
Can individuals currently partake in this clinical experiment?
"Affirmative. The information available on clinicaltrials.gov shows that this research endeavour is currently recruiting participants, the original post being made on May 5th 2022 and last modified November 2nd 2022. 250 individuals are needed to be recruited from 20 different sites for this trial."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger