Clinical trial NCT05403502: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
Control-IQ Technology
lyumjev
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
name: Jaeb Center for Health Research
First posted: 2022-06-03
Enrollment: 183
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 6 to \<81 years
2. Diagnosis of type 1 diabetes for at least 1 year
3. 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
4. Total daily insulin dose (TDD) at least 2 U/day
5. HbA1c \< 10.5%
6. Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation.
7. 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.
8. 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.
9. 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.
10. 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.
11. Participant and/or parent/legal guardian have the ability to read and understand English

Exclusion Criteria:

1. More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
2. More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
3. Inpatient psychiatric treatment in the past 6 months
4. 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.
5. 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.
6. Adults lacking the capacity to provide consent and/or follow study procedures in the opinion of the investigator
7. 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).
8. Hemophilia or any other bleeding disorder
9. Hemoglobinopathy
10. History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
11. History of allergic reaction to Humalog or Lyumjev
12. Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
13. 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)
14. Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
15. History of adrenal insufficiency
16. History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
17. History of gastroparesis
18. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
19. Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
20. 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

Primary outcomes:
measure: Severe Hypoglycemia
timeFrame: 15 weeks
measure: Diabetic Ketoacidosis
timeFrame: 15 weeks
measure: Unanticipated Adverse Device Effects
timeFrame: 15 weeks
Secondary outcomes:
measure: Overall Percent Time Less Than 54 mg/dL
timeFrame: 15 Weeks
measure: Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: Overall Percent Time Less Than 70 mg/dL
timeFrame: 15 weeks
measure: Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
Other outcomes:
measure: Overall Percent Time in Range Between 70-180 mg/dL
timeFrame: 15 weeks
measure: Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)
timeFrame: 15 weeks
measure: Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)
timeFrame: 15 weeks
measure: Overall Percent Time in Range Between 70-140 mg/dL
timeFrame: 15 weeks
measure: Percent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM)
timeFrame: 15 weeks
measure: Percent Time in Range Between 70-140 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)
timeFrame: 15 weeks
measure: Overall Percent Time in Range Greater Than 180 mg/dL
timeFrame: 15 weeks
measure: Percent Time in Range Greater Than 180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)
timeFrame: 15 weeks
measure: Percent Time in Range Greater Than 180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)
timeFrame: 15 weeks
measure: Overall Percent Time in Range Greater Than 250 mg/dL
timeFrame: 15 weeks
measure: Percent Time in Range Greater Than 250 mg/dL, Daytime Only (6:00 AM - 11:59 PM)
timeFrame: 15 weeks
measure: Percent Time in Range Greater Than 250 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)
timeFrame: 15 weeks
measure: Overall CGM Hyperglycemic Events Per Week
timeFrame: 15 weeks
measure: CGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM)
timeFrame: 15 weeks
measure: CGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)
timeFrame: 15 weeks
measure: Overall CGM Hypoglycemia Events Per Week
timeFrame: 15 weeks
measure: CGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM)
timeFrame: 15 weeks
measure: CGM Hypoglycemia Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)
timeFrame: 15 weeks
measure: Overall Mean Glucose
timeFrame: 15 weeks
measure: Mean Glucose, Daytime Only (6:00 AM - 11:59 PM)
timeFrame: 15 weeks
measure: Mean Glucose, Nighttime Only (12:00 AM - 5:59 AM)
timeFrame: 15 weeks
measure: Coefficient of Variation, Overall
timeFrame: 15 weeks
measure: Coefficient of Variation, Daytime Only (6:00 AM - 11:59 PM)
timeFrame: 15 weeks
measure: Coefficient of Variation, Nighttime Only (12:00 AM - 5:59 AM)
timeFrame: 15 weeks
measure: Standard Deviation of All Glucose Values, Overall (24 Hour Day)
timeFrame: 15 weeks
measure: Standard Deviation of All Glucose Values, Daytime Only (6:00 AM - 11:59 PM)
timeFrame: 15 weeks
measure: Standard Deviation of All Glucose Values, Nighttime Only (12:00 AM - 5:59 AM)
timeFrame: 15 weeks
measure: Postprandial Percent Time in Range Between 70-180 mg/dL, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: Postprandial Percent Time in Range Between 70-140 mg/dL, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: Postprandial Percent Time Greater Than 180 mg/dL, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: Postprandial Percent Time Greater Than 250 mg/dL, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: Peak Postprandial Glucose, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: Postprandial Mean Glucose, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: Postprandial Incremental Area Under the Glucose Curve, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: Coefficient of Variation, Postprandial, Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: Standard Deviation of All Glucose Values, Postprandial Through 4 Hours After Each Meal
timeFrame: during 4 hour postprandial period after each meal, up to 15 weeks
measure: HbA1c Change From Baseline
timeFrame: 13 weeks
measure: Patient Reported Outcomes: TRIM-D
timeFrame: 15 weeks
measure: Patient Reported Outcomes: TRIM-DD
timeFrame: 15 weeks
measure: Patient Reported Outcomes: ITSQ
timeFrame: 15 weeks
Locations:
city: Orange
country: United States
facility: Children's Hospital Orange County
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida Diabetes Center
state: Florida
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University / Riley Hospital for Children
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center (IDERC)
state: Iowa
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease (DGD)
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Tandem Diabetes Care
name: Jordan Pinsker, MD
role: STUDY_DIRECTOR
References:
citation: Levy CJ, Bailey R, Laffel LM, Forlenza G, DiMeglio LA, Hughes MS, Brown SA, Aleppo G, Bhargava A, Shah VN, Clements MA, Kipnes M, Bruggeman B, Daniels M, Rodriguez H, Calhoun P, Lum JW, Sasson-Katchalski R, Pinsker JE, Pollom R, Beck RW; TL1 Study Group. Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):652-660. doi: 10.1089/dia.2024.0048. Epub 2024 May 22.