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Insulin
MiniMed 780G System for Type 1 Diabetes
N/A
Waitlist Available
Research Sponsored by Medtronic Diabetes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new insulin (Lyumjev®) with an advanced insulin pump (MiniMed™ 780G) in people aged 7-80 with type 1 diabetes. The pump helps control blood sugar by adjusting insulin delivery automatically. The MiniMed™ 780G is a second-generation advanced system designed to improve blood sugar control in people with type 1 diabetes.
Eligible Conditions
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)
Primary Safety Endpoint for Age 18-80 - Change in HbA1c
+1 moreSecondary study objectives
Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Hypoglycemia
Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MiniMed 780G System Utilizing Insulin Lyumjev®Experimental Treatment1 Intervention
Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MiniMed 780G System
2022
N/A
~490
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Who is running the clinical trial?
Medtronic DiabetesLead Sponsor
69 Previous Clinical Trials
9,957 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,672 Previous Clinical Trials
3,463,498 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: MiniMed 780G System Utilizing Insulin Lyumjev®
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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