Your session is about to expire
← Back to Search
Insulin Pump
Insulin Pump with Continuous Glucose Monitoring for Type 1 Diabetes (SUCCEED2 Trial)
N/A
Recruiting
Research Sponsored by Medtronic Diabetes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 2-6 years at time of screening
Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 6 units on average
Must not have
Has any unresolved adverse skin condition in the area of sensor placement
Is using hydroxyurea at time of screening or plans to use it during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 130 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to assess the safety of using the MiniMed 780G insulin pump with the DS5 continuous glucose monitoring system in young children with type 1 diabetes at home.
Who is the study for?
This trial is for young children aged 2-6 who have Type 1 Diabetes. It's designed to see if using the MiniMed™ 780G insulin pump along with DS5 Continuous Glucose Monitoring (CGM) is safe in a home environment.
What is being tested?
The study tests the safety of combining two diabetes management tools: the MiniMed™ 780G insulin pump and DS5 CGM system, which work together to monitor and adjust blood sugar levels in young kids.
What are the potential side effects?
Possible side effects may include skin irritation from device adhesion, hypoglycemia or hyperglycemia due to insulin delivery issues, and potential inaccuracies in glucose monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 and 6 years old.
Select...
I use at least 6 units of insulin daily.
Select...
I have been diagnosed with type 1 diabetes for at least 3 months.
Select...
I am willing and able to use and pay for the specified insulin for the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have skin issues where a medical device would be placed.
Select...
I am currently using hydroxyurea or plan to use it during the study.
Select...
I have a planned surgery that will need general anesthesia during the study.
Select...
I was hospitalized or visited the ER for uncontrolled diabetes in the last 3 months.
Select...
I am currently taking certain medications.
Select...
I have hemophilia or another bleeding disorder.
Select...
I have chronic kidney disease or am currently on dialysis.
Select...
My thyroid condition is not well-managed.
Select...
I have been diagnosed with adrenal insufficiency.
Select...
I have sickle cell disease or a similar blood condition, or I've had a blood transfusion or erythropoietin treatment in the last 3 months.
Select...
I plan to get a red blood cell transfusion or take erythropoietin during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 130 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~130 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Safety Endpoints
Awards & 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 with DS5Experimental Treatment1 Intervention
Subjects 2-6 years old 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
71 Previous Clinical Trials
11,681 Total Patients Enrolled