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Insulin Pump with Continuous Glucose Monitoring for Type 1 Diabetes
Study Summary
This trial tests the safety and effectiveness of an insulin pump and glucose monitor for adults and kids with type 1 diabetes.
- Type 1 Diabetes
Timeline
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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- You have been using a pump for more than 6 months before the screening.You have a skin condition where the sensor needs to be placed.You have had two or more very low blood sugar episodes in the past 6 months that required medical help, caused a coma, or seizures.You have had to go to the hospital or emergency room because your diabetes was not under control in the last 6 months.You had a serious condition called diabetic ketoacidosis (DKA) in the last 6 months before the screening visit.You are currently getting treatment for hyperthyroidism.You have used a MiniMed 780G pump before the screening.You have had eye problems that would make it unsafe for you to take part in the study or do the study tasks.You are planning to receive a blood transfusion or erythropoietin during the study.You have long-term kidney disease that causes ongoing anemia.You have been diagnosed with type 1 diabetes for at least 2 years and are between 14 and 80 years old.You have three or more heart health problems and have not had a normal EKG in the past six months or been cleared by a doctor.You must be between 7 and 80 years old when you get checked before the study.You are currently taking or planning to take hydroxyurea during the study.You have been diagnosed with adrenal insufficiency.You have taken certain types of steroids by mouth, injection, or IV within the past 8 weeks, or plan to take them during the study.You are currently using illegal drugs, marijuana, prescription drugs, or alcohol in a harmful way.You are currently taking certain diabetes medications like pramlintide, DPP-4 inhibitors, liraglutide, metformin, or canagliflozin.You have celiac disease that is not being properly treated.You are currently receiving dialysis treatment.Your blood test shows high levels of creatinine, a waste product in the blood.This isn't a complete criterion, but "Admelog (insulin lispro injection)" seems to be a medication. If you have a specific question about it, please feel free to ask.You have been diagnosed with type 1 diabetes for at least 1 year and you are between 7 and 13 years old.You have sickle cell disease or a related blood condition, or you have received a blood transfusion or erythropoietin in the last 3 months.If you had certain heart problems in the past year, you need to have had recent heart tests or approval from a doctor before joining the study.You need to take at least 8 units of insulin every day.Your HbA1c level is below 10% when you are screened for the trial.Your thyroid-stimulating hormone (TSH) levels are within the normal range, or if they are not, your Free T3 levels are within the normal range and your Free T4 levels are normal.You have been using a pump to manage your condition for more than 6 months before the screening.You have an eating disorder like anorexia or bulimia right now.Your blood doesn't have enough red blood cells.
- Group 1: MiniMed™ 780G system with DS5
- 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
Do octogenarians qualify for participation in this research project?
"According to the trial's guidelines, those between 7 and 80 years old are suitable for enrollment."
Are participants currently being enlisted for this experiment?
"Evidently, this clinical trial is not presently enrolling new participants. The experiment was initially posted on March 1st 2023 and had its last update around the 26th of January in the same year. Although no longer accepting applicants, there are 370 other studies that need patients right now."
How many sites are facilitating the implementation of this clinical trial?
"This investigation is currently recruiting from 20 different sites, ranging from Palo Alto to Walnut Creek and beyond. Prospective participants should select the nearest location to minimize travel requirements if they decide to join this trial."
What conclusions is this research attempting to reach?
"This clinical trial is evaluating the safety of a new medication and will primarily assess HbA1c levels over three months. Additionally, it aims to evaluate the drug's efficacy by gauging the percent of time in hypoglycemia (Age 7-17) or range (TIR 70-180 mg/dL - Age 18-80 & 7-17) with noninferiority and superiority tests."
Are there any eligibility criteria for participation in this trial?
"This clinical trial is seeking 250 individuals suffering from type 1 diabetes, aged between seven and eighty. Candidates must meet the following criteria: be within the aforementioned age range at time of screening; have a diagnosis that can be verified by medical records or source documentation made by an accredited professional; not require legal representation to provide consent due to mental handicap; demonstrate literacy as well as comprehension in the language used for pump instructions; provide informed consent before enrolling in the study; execute fingerstick blood glucose measurements when needed; wear system continuously during duration of study period; possess minimum daily insulin requirement (Total Daily Dose) greater than 8 units of"
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