Your session is about to expire
← Back to Search
Insulin Pump
Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With 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 during 4 hour postprandial period after each meal, up to 15 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new fast-acting insulin called Lyumjev with a smart insulin pump system in people aged 6 to 80 who have type 1 diabetes. The goal is to see if this combination can better manage their blood sugar levels. Lyumjev is a new ultra-rapid insulin designed to better control hyperglycemia after meals.
Eligible Conditions
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during 4 hour postprandial period after each meal, up to 15 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 4 hour postprandial period after each meal, up to 15 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
Severe Hypoglycemia
Unanticipated Adverse Device Effects
Secondary study objectives
Overall Percent Time Less Than 54 mg/dL
Overall Percent Time Less Than 70 mg/dL
Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal
+1 moreOther study objectives
CGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM)
CGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)
CGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM)
+37 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: t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®Experimental Treatment1 Intervention
Current Control-IQ technology users with type 1 diabetes, age 6-80, will use the t:slim X2 insulin pump with Control-IQ technology 1.5 and Lyumjev insulin for 3-months of outpatient use.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
t:slim X2 insulin pump with Control-IQ technology 1.5
2022
N/A
~220
Find a Location
Who is running the clinical trial?
Tandem Diabetes Care, Inc.Lead Sponsor
40 Previous Clinical Trials
5,610 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,466,201 Total Patients Enrolled
Jaeb Center for Health ResearchOTHER
158 Previous Clinical Trials
35,406 Total Patients Enrolled
Jordan Pinsker, MDStudy DirectorTandem Diabetes Care
12 Previous Clinical Trials
3,854 Total Patients Enrolled