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


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Trial ID: NCT05403502


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.

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

Stanford Investigator(s)

Rayhan A. Lal, MD
Rayhan A. Lal, MD

Assistant Professor of Medicine (Endocrinology) and of Pediatrics (Endocrinology)

Michael Samuel Hughes

Instructor, Medicine - Endocrinology, Gerontology, & Metabolism


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

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

   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


device: t:slim X2 insulin pump with Control-IQ technology 1.5


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Liana Hsu