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Insulin Pump

t:slim X2 insulin pump with Control-IQ technology 1.5 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 during 4 hour postprandial period after each meal, up to 15 weeks
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~during 4 hour postprandial period after each meal, up to 15 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and during 4 hour postprandial period after each meal, up to 15 weeks for reporting.

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 more
Other 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 more

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

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
38 Previous Clinical Trials
5,525 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,651 Previous Clinical Trials
3,224,284 Total Patients Enrolled
Jaeb Center for Health ResearchOTHER
157 Previous Clinical Trials
35,422 Total Patients Enrolled
~59 spots leftby Oct 2025
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