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CompletedNCT05403502Updated Jul 26, 2024Results posted

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

An interventional study of t:slim X2 insulin pump with Control-IQ technology 1.5 in Type 1 Diabetes, sponsored by Tandem Diabetes Care, Inc.. Completed at 13 sites in United States. Open to participants aged 6 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-26.

Sponsored by Tandem Diabetes Care, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
183
Allocation
Not applicable
Ages
6 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • type 1 diabetes
  • Control-IQ Technology
  • lyumjev
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 183 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Tandem Diabetes Care, Inc. is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
183 participants (actual)

Study arms

  • 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

Interventions

  • Devicet: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.

06

What researchers measure

Primary outcomes

  1. 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

  2. Diabetic Ketoacidosis

    Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.

    Time frame: 15 weeks

  3. Unanticipated Adverse Device Effects

    Number of unanticipated adverse device effects (UADE) events

    Time frame: 15 weeks

Secondary outcomes

  1. Overall Percent Time Less Than 54 mg/dL

    CGM overall percent time less than 54 mg/dL

    Time frame: 15 Weeks

  2. 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

  3. Overall Percent Time Less Than 70 mg/dL

    CGM overall percent time less than 70 mg/dL

    Time frame: 15 weeks

  4. 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

Other outcomes

  1. Overall Percent Time in Range Between 70-180 mg/dL

    Overall CGM percent time in range between 70-180 mg/dL

    Time frame: 15 weeks

  2. Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)

    CGM percent time in range between 70-180 mg/dL, daytime only (6:00 AM - 11:59 PM)

    Time frame: 15 weeks

  3. Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)

    CGM percent time in range between 70-180 mg/dL, nighttime only (12:00 AM - 5:59 AM)

    Time frame: 15 weeks

  4. Overall Percent Time in Range Between 70-140 mg/dL

    Overall CGM percent time in range between 70-140 mg/dL

    Time frame: 15 weeks

  5. Percent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM)

    CGM percent time in range between 70-140 mg/dL, daytime only (6:00 AM - 11:59 PM)

    Time frame: 15 weeks

  6. Percent Time in Range Between 70-140 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)

    CGM percent time in range between 70-140 mg/dL, nighttime only (12:00 AM - 5:59 AM)

    Time frame: 15 weeks

  7. Overall Percent Time in Range Greater Than 180 mg/dL

    Overall CGM percent time in range greater than 180 mg/dL

    Time frame: 15 weeks

  8. Percent Time in Range Greater Than 180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)

    CGM percent time in range greater than 180 mg/dL, daytime only (6:00 AM - 11:59 PM)

    Time frame: 15 weeks

  9. Percent Time in Range Greater Than 180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)

    CGM percent time in range greater than 180 mg/dL, nighttime only (12:00 AM - 5:59 AM)

    Time frame: 15 weeks

  10. Overall Percent Time in Range Greater Than 250 mg/dL

    Overall CGM percent time in range greater than 250 mg/dL

    Time frame: 15 weeks

  11. Percent Time in Range Greater Than 250 mg/dL, Daytime Only (6:00 AM - 11:59 PM)

    CGM percent time in range greater than 250 mg/dL, daytime only (6:00 AM - 11:59 PM)

    Time frame: 15 weeks

  12. Percent Time in Range Greater Than 250 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)

    CGM percent time in range greater than 250 mg/dL, nighttime only (12:00 AM - 5:59 AM)

    Time frame: 15 weeks

  13. Overall CGM Hyperglycemic Events Per Week

    Overall CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within a 120 minute window

    Time frame: 15 weeks

  14. CGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM)

    CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within 120 minute window, daytime only (6:00 AM - 11:59 PM)

    Time frame: 15 weeks

  15. CGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)

    CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within 120 minute window, nighttime only (12:00 AM - 5:59 AM)

    Time frame: 15 weeks

  16. Overall CGM Hypoglycemia Events Per Week

    Overall CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL

    Time frame: 15 weeks

  17. CGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM)

    CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, daytime only (6:00 AM - 11:59 PM)

    Time frame: 15 weeks

  18. CGM Hypoglycemia Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)

    CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, nighttime only (12:00 AM - 5:59 AM)

    Time frame: 15 weeks

  19. Overall Mean Glucose

    Overall CGM mean glucose mg/dL

    Time frame: 15 weeks

  20. Mean Glucose, Daytime Only (6:00 AM - 11:59 PM)

    CGM mean glucose mg/dL, daytime only (6:00 AM - 11:59 PM)

    Time frame: 15 weeks

  21. Mean Glucose, Nighttime Only (12:00 AM - 5:59 AM)

    CGM mean glucose mg/dL, nighttime only (12:00 AM - 5:59 AM)

    Time frame: 15 weeks

  22. Coefficient of Variation, Overall

    CGM measured Coefficient of Variation, Overall

    Time frame: 15 weeks

  23. Coefficient of Variation, Daytime Only (6:00 AM - 11:59 PM)

    CGM measured Coefficient of Variation, daytime only (6:00 AM - 11:59 PM)

    Time frame: 15 weeks

  24. Coefficient of Variation, Nighttime Only (12:00 AM - 5:59 AM)

    CGM measured Coefficient of Variation, nighttime only (12:00 AM - 5:59 AM)

    Time frame: 15 weeks

  25. Standard Deviation of All Glucose Values, Overall (24 Hour Day)

    CGM measured Standard Deviation of all glucose values (mg/dL), Overall ( 24 Hour Day). Standard Deviation of Mean Glucose is shown separately in Outcome 26.

    Time frame: 15 weeks

  26. Standard Deviation of All Glucose Values, Daytime Only (6:00 AM - 11:59 PM)

    CGM measured Standard Deviation of all Glucose Values (mg/dL), daytime only (6:00 AM - 11:59 PM). Standard Deviation of Mean Glucose, Daytime only, is shown separately in Outcome 27.

    Time frame: 15 weeks

  27. Standard Deviation of All Glucose Values, Nighttime Only (12:00 AM - 5:59 AM)

    CGM measured Standard Deviation of all Glucose Values (mg/dL), nighttime only (12:00 AM - 5:59 AM). Standard Deviation of Mean Glucose, Nighttime only, is shown separately in Outcome 28.

    Time frame: 15 weeks

  28. Postprandial Percent Time in Range Between 70-180 mg/dL, Through 4 Hours After Each Meal

    Postprandial CGM percent time in range between 70-180 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

  29. Postprandial Percent Time in Range Between 70-140 mg/dL, Through 4 Hours After Each Meal

    Postprandial CGM percent time in range between 70-140 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

  30. Postprandial Percent Time Greater Than 180 mg/dL, Through 4 Hours After Each Meal

    Postprandial CGM percent time greater than 180 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

  31. Postprandial Percent Time Greater Than 250 mg/dL, Through 4 Hours After Each Meal

    Postprandial CGM percent time greater than 250 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

  32. Peak Postprandial Glucose, Through 4 Hours After Each Meal

    Peak postprandial glucose (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

  33. Postprandial Mean Glucose, Through 4 Hours After Each Meal

    Postprandial CGM mean glucose (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

  34. Postprandial Incremental Area Under the Glucose Curve, Through 4 Hours After Each Meal

    CGM postprandial incremental area under the glucose curve, 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

  35. Coefficient of Variation, Postprandial, Through 4 Hours After Each Meal

    CGM measured Coefficient of Variation, Postprandial, 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

  36. Standard Deviation of All Glucose Values, Postprandial Through 4 Hours After Each Meal

    CGM measured Standard Deviation of all glucose values (mg/dL), Postprandial through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study. Standard Deviation of Mean Glucose, Postprandial through 4 hours after each meal, is shown separately in Outcome 40.

    Time frame: during 4 hour postprandial period after each meal, up to 15 weeks

  37. HbA1c Change From Baseline

    Change in HbA1c from End of Humalog Lead-in Period (End of Week 2) to End of Lyumjev Treatment Period (End of Week 15)

    Time frame: 13 weeks

  38. Patient Reported Outcomes: TRIM-D

    Patient Reported Outcomes on the Treatment Related Impact Measure-Diabetes (TRIM-D) scale. Total score measured on a scale of 0 to 100 with higher scores indicating better diabetes treatment impact. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).

    Time frame: 15 weeks

  39. Patient Reported Outcomes: TRIM-DD

    Patient Reported Outcomes on the Treatment Related Impact Measure - diabetes device (TRIM-DD) scale. Measured on a scale of 0 to 100 with higher scores indicating more positive diabetes device impact. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).

    Time frame: 15 weeks

  40. Patient Reported Outcomes: ITSQ

    Patient Reported Outcomes on the Insulin Treatment Satisfaction Questionnaire (ITSQ) scale. Measured on a scale of 0 to 100 with higher scores indicating better treatment satisfaction. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).

    Time frame: 15 weeks

07

Results

Posted Jul 26, 2024

Participant flow

Humalog Lead-In Period
Participant flow — Humalog Lead-In Period
MilestoneUsers of Tandem t:Slim X2 Insulin Pump With Control-IQ 1.5 Technology
Started183
Completed179
Not completed4
Withdrew: Withdrawal by subject1
Withdrew: Physician decision2
Withdrew: Protocol violation1
Lyumjev Treatment Period
Participant flow — Lyumjev Treatment Period
MilestoneUsers of Tandem t:Slim X2 Insulin Pump With Control-IQ 1.5 Technology
Started179
Completed173
Not completed6
Withdrew: Withdrawal by subject4
Withdrew: Physician decision2

Outcome measures

PrimarySevere 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
Reported as:
Number · events
Severe Hypoglycemia
eventsClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)0
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)3
PrimaryDiabetic Ketoacidosis

Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.

Time frame:
15 weeks
Reported as:
Number · events
Diabetic Ketoacidosis
eventsClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)0
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)0
PrimaryUnanticipated Adverse Device Effects

Number of unanticipated adverse device effects (UADE) events

Time frame:
15 weeks
Reported as:
Number · events
Unanticipated Adverse Device Effects
eventsClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)0
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)0
SecondaryOverall Percent Time Less Than 54 mg/dL

CGM overall percent time less than 54 mg/dL

Time frame:
15 Weeks
Reported as:
Mean · percentage of time
Overall Percent Time Less Than 54 mg/dL
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)0.27 ± 0.35
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)0.26 ± 0.27
SecondaryPostprandial 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
Reported as:
Mean · percentage of time
Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)0.26 ± 0.44
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)0.31 ± 0.37
SecondaryOverall Percent Time Less Than 70 mg/dL

CGM overall percent time less than 70 mg/dL

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Overall Percent Time Less Than 70 mg/dL
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)1.4 ± 1.3
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)1.2 ± 1.0
SecondaryPostprandial 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
Reported as:
Mean · percentage of time
Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)1.5 ± 1.5
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)1.6 ± 1.4
Other pre-specifiedOverall Percent Time in Range Between 70-180 mg/dL

Overall CGM percent time in range between 70-180 mg/dL

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Overall Percent Time in Range Between 70-180 mg/dL
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)65 ± 15
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)67 ± 13
Other pre-specifiedPercent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)

CGM percent time in range between 70-180 mg/dL, daytime only (6:00 AM - 11:59 PM)

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)62 ± 15
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)64 ± 14
Other pre-specifiedPercent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)

CGM percent time in range between 70-180 mg/dL, nighttime only (12:00 AM - 5:59 AM)

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)72 ± 18
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)75 ± 15
Other pre-specifiedOverall Percent Time in Range Between 70-140 mg/dL

Overall CGM percent time in range between 70-140 mg/dL

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Overall Percent Time in Range Between 70-140 mg/dL
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)40 ± 14
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)42 ± 13
Other pre-specifiedPercent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM)

CGM percent time in range between 70-140 mg/dL, daytime only (6:00 AM - 11:59 PM)

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Percent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM)
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)38 ± 14
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)40 ± 13
Other pre-specifiedPercent Time in Range Between 70-140 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)

CGM percent time in range between 70-140 mg/dL, nighttime only (12:00 AM - 5:59 AM)

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Percent Time in Range Between 70-140 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)47 ± 20
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)49 ± 18
Other pre-specifiedOverall Percent Time in Range Greater Than 180 mg/dL

Overall CGM percent time in range greater than 180 mg/dL

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Overall Percent Time in Range Greater Than 180 mg/dL
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)34 ± 15
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)32 ± 13
Other pre-specifiedPercent Time in Range Greater Than 180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)

CGM percent time in range greater than 180 mg/dL, daytime only (6:00 AM - 11:59 PM)

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Percent Time in Range Greater Than 180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)36 ± 16
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)34 ± 14
Other pre-specifiedPercent Time in Range Greater Than 180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)

CGM percent time in range greater than 180 mg/dL, nighttime only (12:00 AM - 5:59 AM)

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Percent Time in Range Greater Than 180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)26 ± 18
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)24 ± 15
Other pre-specifiedOverall Percent Time in Range Greater Than 250 mg/dL

Overall CGM percent time in range greater than 250 mg/dL

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Overall Percent Time in Range Greater Than 250 mg/dL
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)12 ± 10
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)11 ± 8
Other pre-specifiedPercent Time in Range Greater Than 250 mg/dL, Daytime Only (6:00 AM - 11:59 PM)

CGM percent time in range greater than 250 mg/dL, daytime only (6:00 AM - 11:59 PM)

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Percent Time in Range Greater Than 250 mg/dL, Daytime Only (6:00 AM - 11:59 PM)
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)13 ± 11
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)12 ± 10
Other pre-specifiedPercent Time in Range Greater Than 250 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)

CGM percent time in range greater than 250 mg/dL, nighttime only (12:00 AM - 5:59 AM)

Time frame:
15 weeks
Reported as:
Mean · percentage of time
Percent Time in Range Greater Than 250 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)9 ± 9
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)8 ± 7
Other pre-specifiedOverall CGM Hyperglycemic Events Per Week

Overall CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within a 120 minute window

Time frame:
15 weeks
Reported as:
Mean · events per week
Overall CGM Hyperglycemic Events Per Week
events per weekClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)1.8 ± 1.9
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)1.6 ± 1.6
Other pre-specifiedCGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM)

CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within 120 minute window, daytime only (6:00 AM - 11:59 PM)

Time frame:
15 weeks
Reported as:
Mean · events per week
CGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM)
events per weekClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)1.5 ± 1.8
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)1.4 ± 1.5
Other pre-specifiedCGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)

CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within 120 minute window, nighttime only (12:00 AM - 5:59 AM)

Time frame:
15 weeks
Reported as:
Mean · events per week
CGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)
events per weekClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)0.4 ± 0.6
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)0.3 ± 0.4
Other pre-specifiedOverall CGM Hypoglycemia Events Per Week

Overall CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL

Time frame:
15 weeks
Reported as:
Mean · events per week
Overall CGM Hypoglycemia Events Per Week
events per weekClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)0.46 ± 0.75
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)0.49 ± 0.55
Other pre-specifiedCGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM)

CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, daytime only (6:00 AM - 11:59 PM)

Time frame:
15 weeks
Reported as:
Mean · events per week
CGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM)
events per weekClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)0.32 ± 0.59
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)0.37 ± 0.46
Other pre-specifiedCGM Hypoglycemia Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)

CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, nighttime only (12:00 AM - 5:59 AM)

Time frame:
15 weeks
Reported as:
Mean · events per week
CGM Hypoglycemia Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)
events per weekClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)0.09 ± 0.24
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)0.09 ± 0.14
Other pre-specifiedOverall Mean Glucose

Overall CGM mean glucose mg/dL

Time frame:
15 weeks
Reported as:
Mean · mg/dL
Overall Mean Glucose
mg/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)167 ± 26
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)165 ± 23
Other pre-specifiedMean Glucose, Daytime Only (6:00 AM - 11:59 PM)

CGM mean glucose mg/dL, daytime only (6:00 AM - 11:59 PM)

Time frame:
15 weeks
Reported as:
Mean · mg/dL
Mean Glucose, Daytime Only (6:00 AM - 11:59 PM)
mg/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)171 ± 27
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)168 ± 25
Other pre-specifiedMean Glucose, Nighttime Only (12:00 AM - 5:59 AM)

CGM mean glucose mg/dL, nighttime only (12:00 AM - 5:59 AM)

Time frame:
15 weeks
Reported as:
Mean · mg/dL
Mean Glucose, Nighttime Only (12:00 AM - 5:59 AM)
mg/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)157 ± 28
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)156 ± 23
Other pre-specifiedCoefficient of Variation, Overall

CGM measured Coefficient of Variation, Overall

Time frame:
15 weeks
Reported as:
Mean · percentage of coefficient of variation
Coefficient of Variation, Overall
percentage of coefficient of variationClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)36 ± 5
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)36 ± 5
Other pre-specifiedCoefficient of Variation, Daytime Only (6:00 AM - 11:59 PM)

CGM measured Coefficient of Variation, daytime only (6:00 AM - 11:59 PM)

Time frame:
15 weeks
Reported as:
Mean · percentage of coefficient of variation
Coefficient of Variation, Daytime Only (6:00 AM - 11:59 PM)
percentage of coefficient of variationClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)36 ± 5
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)36 ± 5
Other pre-specifiedCoefficient of Variation, Nighttime Only (12:00 AM - 5:59 AM)

CGM measured Coefficient of Variation, nighttime only (12:00 AM - 5:59 AM)

Time frame:
15 weeks
Reported as:
Mean · percentage of coefficient of variation
Coefficient of Variation, Nighttime Only (12:00 AM - 5:59 AM)
percentage of coefficient of variationClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)32 ± 8
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)33 ± 6
Other pre-specifiedStandard Deviation of All Glucose Values, Overall (24 Hour Day)

CGM measured Standard Deviation of all glucose values (mg/dL), Overall ( 24 Hour Day). Standard Deviation of Mean Glucose is shown separately in Outcome 26.

Time frame:
15 weeks
Reported as:
Mean · mg/dL
Standard Deviation of All Glucose Values, Overall (24 Hour Day)
mg/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)61 ± 15
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)60 ± 14
Other pre-specifiedStandard Deviation of All Glucose Values, Daytime Only (6:00 AM - 11:59 PM)

CGM measured Standard Deviation of all Glucose Values (mg/dL), daytime only (6:00 AM - 11:59 PM). Standard Deviation of Mean Glucose, Daytime only, is shown separately in Outcome 27.

Time frame:
15 weeks
Reported as:
Mean · mg/dL
Standard Deviation of All Glucose Values, Daytime Only (6:00 AM - 11:59 PM)
mg/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)62 ± 15
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)61 ± 14
Other pre-specifiedStandard Deviation of All Glucose Values, Nighttime Only (12:00 AM - 5:59 AM)

CGM measured Standard Deviation of all Glucose Values (mg/dL), nighttime only (12:00 AM - 5:59 AM). Standard Deviation of Mean Glucose, Nighttime only, is shown separately in Outcome 28.

Time frame:
15 weeks
Reported as:
Mean · mg/dL
Standard Deviation of All Glucose Values, Nighttime Only (12:00 AM - 5:59 AM)
mg/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)52 ± 18
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)52 ± 15
Other pre-specifiedPostprandial Percent Time in Range Between 70-180 mg/dL, Through 4 Hours After Each Meal

Postprandial CGM percent time in range between 70-180 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
Reported as:
Mean · percentage of time
Postprandial Percent Time in Range Between 70-180 mg/dL, Through 4 Hours After Each Meal
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)55 ± 17
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)57 ± 16
Other pre-specifiedPostprandial Percent Time in Range Between 70-140 mg/dL, Through 4 Hours After Each Meal

Postprandial CGM percent time in range between 70-140 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
Reported as:
Mean · percentage of time
Postprandial Percent Time in Range Between 70-140 mg/dL, Through 4 Hours After Each Meal
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)32 ± 14
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)33 ± 13
Other pre-specifiedPostprandial Percent Time Greater Than 180 mg/dL, Through 4 Hours After Each Meal

Postprandial CGM percent time greater than 180 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
Reported as:
Mean · percentage of time
Postprandial Percent Time Greater Than 180 mg/dL, Through 4 Hours After Each Meal
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)43 ± 18
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)42 ± 16
Other pre-specifiedPostprandial Percent Time Greater Than 250 mg/dL, Through 4 Hours After Each Meal

Postprandial CGM percent time greater than 250 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
Reported as:
Mean · percentage of time
Postprandial Percent Time Greater Than 250 mg/dL, Through 4 Hours After Each Meal
percentage of timeClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)16 ± 14
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)15 ± 12
Other pre-specifiedPeak Postprandial Glucose, Through 4 Hours After Each Meal

Peak postprandial glucose (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
Reported as:
Mean · mg/dL
Peak Postprandial Glucose, Through 4 Hours After Each Meal
mg/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)244 ± 40
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)241 ± 38
Other pre-specifiedPostprandial Mean Glucose, Through 4 Hours After Each Meal

Postprandial CGM mean glucose (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
Reported as:
Mean · mg/dL
Postprandial Mean Glucose, Through 4 Hours After Each Meal
mg/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)180 ± 32
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)177 ± 28
Other pre-specifiedPostprandial Incremental Area Under the Glucose Curve, Through 4 Hours After Each Meal

CGM postprandial incremental area under the glucose curve, 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
Reported as:
Mean · mg*hr/dL
Postprandial Incremental Area Under the Glucose Curve, Through 4 Hours After Each Meal
mg*hr/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)31 ± 12
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)30 ± 8
Other pre-specifiedCoefficient of Variation, Postprandial, Through 4 Hours After Each Meal

CGM measured Coefficient of Variation, Postprandial, 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
Reported as:
Mean · percentage of coefficient of variation
Coefficient of Variation, Postprandial, Through 4 Hours After Each Meal
percentage of coefficient of variationClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)36 ± 6
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)36 ± 5
Other pre-specifiedStandard Deviation of All Glucose Values, Postprandial Through 4 Hours After Each Meal

CGM measured Standard Deviation of all glucose values (mg/dL), Postprandial through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study. Standard Deviation of Mean Glucose, Postprandial through 4 hours after each meal, is shown separately in Outcome 40.

Time frame:
during 4 hour postprandial period after each meal, up to 15 weeks
Reported as:
Mean · mg/dL
Standard Deviation of All Glucose Values, Postprandial Through 4 Hours After Each Meal
mg/dLClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Humalog Lead-In Period Weeks 1-2 (2 Weeks)64 ± 15
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)64 ± 14
Other pre-specifiedHbA1c Change From Baseline

Change in HbA1c from End of Humalog Lead-in Period (End of Week 2) to End of Lyumjev Treatment Period (End of Week 15)

Time frame:
13 weeks
Reported as:
Mean · percentage of glycated hemoglobin
HbA1c Change From Baseline
percentage of glycated hemoglobinClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
HbA1c Change From Baseline-0.1 (-0.2 to 0.0)
Other pre-specifiedPatient Reported Outcomes: TRIM-D

Patient Reported Outcomes on the Treatment Related Impact Measure-Diabetes (TRIM-D) scale. Total score measured on a scale of 0 to 100 with higher scores indicating better diabetes treatment impact. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).

Time frame:
15 weeks
Reported as:
Mean · score on a scale
Patient Reported Outcomes: TRIM-D
score on a scaleClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Start of Humalog Lead-In Period (Start of Week 1)74 ± 12
Lyumjev Treatment Period (End of Week 15)80 ± 12
Other pre-specifiedPatient Reported Outcomes: TRIM-DD

Patient Reported Outcomes on the Treatment Related Impact Measure - diabetes device (TRIM-DD) scale. Measured on a scale of 0 to 100 with higher scores indicating more positive diabetes device impact. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).

Time frame:
15 weeks
Reported as:
Mean · score on a scale
Patient Reported Outcomes: TRIM-DD
score on a scaleClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Start of Humalog Lead-In Period (Start of Week 1)82 ± 11
Lyumjev Treatment Period (End of Week 15)86 ± 12
Other pre-specifiedPatient Reported Outcomes: ITSQ

Patient Reported Outcomes on the Insulin Treatment Satisfaction Questionnaire (ITSQ) scale. Measured on a scale of 0 to 100 with higher scores indicating better treatment satisfaction. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).

Time frame:
15 weeks
Reported as:
Mean · score on a scale
Patient Reported Outcomes: ITSQ
score on a scaleClosed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
Start of Humalog Lead-In Period (Start of Week 1)75 ± 13
Lyumjev Treatment Period (End of Week 15)80 ± 11

Adverse events

Collected over 15 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
t:Slim X2 Insulin Pump With Control-IQ Technology Utilizing Insulin Lyumjev®0/183 (0%)5/183 (2.7%)127/183 (69.4%)
Most frequent serious events
Most frequent serious events
Eventt:Slim X2 Insulin Pump With Control-IQ Technology Utilizing Insulin Lyumjev®
Severe HypoglycemiaEndocrine disorders3/183
Other Serious Adverse EventNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/183
Other Serious Adverse EventInfections and infestations1/183
Diabetic Ketoacidosis (DKA)Endocrine disorders0/183
Most frequent other events
Most frequent other events
Eventt:Slim X2 Insulin Pump With Control-IQ Technology Utilizing Insulin Lyumjev®
Nonglycemic adverse eventsGeneral disorders81/183
Hyperglycemia with or without ketosis related to study deviceEndocrine disorders32/183
Nonglycemic adverse eventsGeneral disorders19/183
Hyperglycemia with or without ketosis related to study deviceEndocrine disorders7/183
Hyperglycemia with or without ketosis not related to the study deviceEndocrine disorders5/183
Hyperglycemia with or without ketosis not related to the study deviceEndocrine disorders4/183
Nonsevere HypoglycemiaEndocrine disorders0/183
Nonsevere HypoglycemiaEndocrine disorders0/183

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period
<=18 years109
Between 18 and 65 years61
>=65 years9
Age, Continuous
Age, Continuous(years)Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period
Mean24 ± 17
Sex: Female, Male
Sex: Female, Male(Participants)Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period
Female90
Male89
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period
Hispanic or Latino12
Not Hispanic or Latino165
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period
American Indian or Alaska Native1
Asian2
Native Hawaiian or Other Pacific Islander1
Black or African American1
White166
More than one race4
Unknown or Not Reported4
Region of Enrollment
Region of Enrollment(participants)Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period
United States179
Diabetes Duration at Enrollment
Diabetes Duration at Enrollment(years)Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period
Mean14 ± 13
08

Study locations

13 sites
  • Children's Hospital Orange County
    Orange, California 92868, United States
  • Stanford University
    Palo Alto, California 94304, United States
  • Barbara Davis Center
    Aurora, Colorado 80045, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • University of South Florida Diabetes Center
    Tampa, Florida 33612, United States
  • Northwestern University
    Evanston, Illinois 60208, United States
  • Indiana University / Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
  • Iowa Diabetes and Endocrinology Research Center (IDERC)
    West Des Moines, Iowa 50265, United States
  • Joslin Diabetes Center
    Boston, Massachusetts 02215, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
  • Icahn School of Medicine at Mt. Sinai
    New York, New York 10029, United States
  • Diabetes & Glandular Disease (DGD)
    San Antonio, Texas 78229, United States
  • University of Virginia
    Charlottesville, Virginia 22903, United States
09

References and documents

Publications

  • 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. PubMed 38696672 ↗

Study documents

  • Study protocol · Apr 13, 2022
  • Statistical analysis plan · Aug 25, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05403502
Lead sponsor
Tandem Diabetes Care, Inc.
Collaborators
Eli Lilly and Company, Jaeb Center for Health Research
Responsible party
Sponsor
First posted
Jun 3, 2022
Start date
Aug 31, 2022
Primary completion
Aug 2, 2023
Completion
Aug 2, 2023
Results posted
Jul 26, 2024
Last update
Jul 26, 2024

Study contacts

Jordan Pinsker, MD
study director · Tandem Diabetes Care

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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