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Device
Control-IQ technology 2.0 for Type 1 Diabetes
N/A
Waitlist Available
Research Sponsored by Tandem Diabetes Care, Inc.
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 8 weeks
Awards & highlights
Summary
This trial is testing new features for an insulin pump, to see if they are safe and work well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diabetic Ketoacidosis
Serious Adverse Events
Severe hypoglycemia (needing assistance)
+1 moreSecondary study objectives
CGM Metrics by time of day
Percent of time 70-140 mg/dL
Percent of time 70-180 mg/dL
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Control-IQ 2.0 technology 2.0 on the t:slim X2 insulin pumpExperimental Treatment1 Intervention
Each subject will use different combinations of new features of the system each week, in random order, over the next 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
The first 5 subjects in the study will complete a 48 hour session with multiple challenges during use of Control-IQ technology 2.0, before moving on the outpatient portion of the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control-IQ technology 2.0
2021
N/A
~40
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Who is running the clinical trial?
Tandem Diabetes Care, Inc.Lead Sponsor
38 Previous Clinical Trials
5,675 Total Patients Enrolled
Jordan E Pinsker, MDStudy ChairTandem Diabetes Care, Inc.
9 Previous Clinical Trials
178 Total Patients Enrolled
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