Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.
This is a prospective, multi-center, single-arm study in adults and children (ages 6 to 80 years) with type 1 diabetes who are current users of the t:slim X2 insulin pump with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump. After a run-in period, participants will use the study pump with Control-IQ technology 1.5 and Lyumjev insulin for a 3-month outpatient treatment period. Up to 200 participants will be enrolled so at least 160 complete the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
183
t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.
Children's Hospital Orange County
Orange, California, United States
Stanford University
Palo Alto, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Severe Hypoglycemia
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study
Time frame: 15 weeks
Diabetic Ketoacidosis
Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.
Time frame: 15 weeks
Unanticipated Adverse Device Effects
Number of unanticipated adverse device effects (UADE) events
Time frame: 15 weeks
Overall Percent Time Less Than 54 mg/dL
CGM overall percent time less than 54 mg/dL
Time frame: 15 Weeks
Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal
CGM postprandial percent time less than 54 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.
Time frame: during 4 hour postprandial period after each meal, up to 15 weeks
Overall Percent Time Less Than 70 mg/dL
CGM overall percent time less than 70 mg/dL
Time frame: 15 weeks
Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal
CGM postprandial percent time less than 70 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.
Time frame: during 4 hour postprandial period after each meal, up to 15 weeks
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University of Florida
Gainesville, Florida, United States
University of South Florida Diabetes Center
Tampa, Florida, United States
Northwestern University
Evanston, Illinois, United States
Indiana University / Riley Hospital for Children
Indianapolis, Indiana, United States
Iowa Diabetes and Endocrinology Research Center (IDERC)
West Des Moines, Iowa, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
...and 3 more locations