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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

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

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

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: 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

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