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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: t:slim X2 insulin pump with Control-IQ technology 1.5

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.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Children's Hospital Orange County
    • Palo Alto, California, United States, 94304
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida Diabetes Center
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University / Riley Hospital for Children
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Research Center (IDERC)
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
  • Texas
    • San Antonio, Texas, United States, 78229
      • Diabetes & Glandular Disease (DGD)
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®; 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.	Device: t:slim X2 insulin pump with Control-IQ technology 1.5; t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe hypoglycemia	Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry	3 months
Diabetic ketoacidosis	Number of diabetic ketoacidosis events	3 months
Unanticipated adverse device effects	Number of unanticipated adverse device effects (UADE) events	3 months
Other serious adverse events	Number of other serious adverse events	3 months
Adverse drug reactions	Number of adverse drug reactions	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All reportable adverse events	Number of reportable adverse events during the course of the study	3 months
CGM hypoglycemia outcomes: Overall % time <54 mg/dL	CGM overall percent time < 54 mg/dL	3 months
CGM hypoglycemia outcomes: Postprandial % time <54 mg/dL	CGM postprandial percent time < 54 mg/dL	3 months
CGM hypoglycemia outcomes: Overall % time <70 mg/dL	CGM overall percent time < 70 mg/dL	3 months
CGM hypoglycemia outcomes: Postprandial % time <70 mg/dL	CGM postprandial percent time < 70 mg/dL	3 months
CGM hypoglycemia outcomes: Rate of hypoglycemia events	Rate of hypoglycemia events defined as 15 or more consecutive minutes <54 mg/dL	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial incremental area under the glucose curve	CGM postprandial incremental area under the glucose curve (4 hr)	4 hours
Peak postprandial glucose	Peak postprandial glucose (mg/dL)	4 hours
Time in range - overall and postprandial 70-180 mg/dL	CGM time in range 70-180 mg/dL overall and postprandial	3 months
Time in range - overall and postprandial >180 mg/dL	CGM time in range >180 mg/dL overall and postprandial	3 months
Time in range - overall and postprandial >250 mg/dL	CGM time in range >250 mg/dL overall and postprandial	3 months
Times in range - overall and postprandial 70-140 mg/dL	CGM time in range 70-140 mg/dL overall and postprandial	3 months
Mean glucose	Mean CGM glucose mg/dL	3 months
Rate of hyperglycemia events	Rate of hyperglycemia events, defined as 90 or more minutes >300 mg/dL within 120 minutes	3 months
Overall variability (Coefficient of Variation and Standard Deviation)	CGM overall variability as measured by Coefficient of Variation and Standard Deviation (mg/dL)	3 months
HbA1c change from baseline	Change in HbA1c (%) from baseline to 3 months	3 months
CGM metrics for time in range by time of day	CGM metrics for time in range for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).	3 months
CGM metrics for time in hypoglycemia by time of day	CGM metrics for time in hypoglycemia for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).	3 months
CGM metrics for time in hyperglycemia by time of day	CGM metrics for time in hyperglycemia for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).	3 months
CGM metrics for glucose variability by time of day	CGM metrics for glucose variability for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).	3 months
Patient Reported Outcomes: TRIM-D	Patient Reported Outcomes on the TRIM-D scale, comparing baseline to 3 months	3 months
Patient Reported Outcomes: TRIM-DD	Patient Reported Outcomes on the TRIM-DD scale, comparing baseline to 3 months	3 months
Patient Reported Outcomes: ITSQ	Patient Reported Outcomes on the ITSQ scale, comparing baseline to 3 months	3 months

Collaborators and Investigators

• Sponsor: Tandem Diabetes Care, Inc.
• Collaborators: Eli Lilly and Company; Jaeb Center for Health Research
• Investigators: Study Director: Jordan Pinsker, MD, Tandem Diabetes Care

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): August 2, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: type 1 diabetes; Control-IQ Technology; lyumjev
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: TP-0009650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes