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Insulin Pump with Continuous Glucose Monitoring
Insulin Pump with Continuous Glucose Monitoring 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
Summary
This trial tests the safety and effectiveness of an insulin pump and glucose monitor for adults and kids 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
+1 moreSide effects data
From 2016 Phase 4 trial • 85 Patients • NCT0197024121%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control
Trial Design
1Treatment groups
Experimental Treatment
Group I: MiniMed™ 780G system with DS5Experimental Treatment1 Intervention
Subjects with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin Pump with Continuous Glucose Monitoring
2023
N/A
~250
Find a Location
Who is running the clinical trial?
Medtronic DiabetesLead Sponsor
67 Previous Clinical Trials
9,751 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: MiniMed™ 780G system with DS5
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.
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT05714059 — N/A
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