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

Not Applicable

Completed

Conditions: Type 1 Diabetes

Registration Number: NCT05403502

Lead Sponsor: Tandem Diabetes Care, Inc.

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 183

Inclusion Criteria

Age 6 to <81 years
Diagnosis of type 1 diabetes for at least 1 year
Currently using Control-IQ technology for at least 3 months, with CGM data recorded indicative of system use (active closed loop) for at least 85% of the possible time in 14 days prior to enrollment
Total daily insulin dose (TDD) at least 2 U/day
HbA1c < 10.5%
Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation.
For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study.
If >18 years old, participant has someone who lives within 30 minutes of them who is willing to be contacted if the study team can't reach the participant in case of a suspected medical emergency.
Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF) and assent, if applicable; and has agreed to follow all study procedures, including:
1. suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use
2. switching to or continuing to use Humalog during the lead-in period
3. switching to Lyumjev for the main study period.
4. willing and able to perform the study exercise and meal challenges.
Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management.
Participant and/or parent/legal guardian have the ability to read and understand English

Exclusion Criteria

More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
Inpatient psychiatric treatment in the past 6 months
History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study.
For Female: Currently pregnant or planning to become pregnant during the time period of study participation
1. A negative pregnancy test will be required for all females of child-bearing potential (menarchal)
2. Counseling on appropriate birth control options will be provided to females with child-bearing potential in the event the participant does not have an acceptable plan.
Adults lacking the capacity to provide consent and/or follow study procedures in the opinion of the investigator
Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
Hemophilia or any other bleeding disorder
Hemoglobinopathy
History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
History of allergic reaction to Humalog or Lyumjev
Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (>450 ms) (Screening ECG only required for participants age > 50 years, duration of diabetes > 20 years, or history of coronary artery disease)
Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
History of adrenal insufficiency
History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
History of gastroparesis
A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., Eli Lilly and Co., or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diabetic Ketoacidosis	15 weeks	Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.
Severe Hypoglycemia	15 weeks	Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study
Unanticipated Adverse Device Effects	15 weeks	Number of unanticipated adverse device effects (UADE) events

Secondary Outcome Measures

Name	Time	Method
Overall Percent Time Less Than 70 mg/dL	15 weeks	CGM overall percent time less than 70 mg/dL
Overall Percent Time Less Than 54 mg/dL	15 Weeks	CGM overall percent time less than 54 mg/dL
Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal	during 4 hour postprandial period after each meal, up to 15 weeks	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.
Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal	during 4 hour postprandial period after each meal, up to 15 weeks	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.

Trial Locations

Locations (13): Stanford University
🇺🇸
Palo Alto, California, United States
Icahn School of Medicine at Mt. Sinai
🇺🇸
New York, New York, United States
Children's Hospital Orange County
🇺🇸
Orange, California, United States
Iowa Diabetes and Endocrinology Research Center (IDERC)
🇺🇸
West Des Moines, Iowa, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
Barbara Davis Center
🇺🇸
Aurora, Colorado, 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
Joslin Diabetes Center
🇺🇸
Boston, Massachusetts, United States
Children's Mercy Hospital
🇺🇸
Kansas City, Missouri, United States
Diabetes & Glandular Disease (DGD)
🇺🇸
San Antonio, Texas, United States