Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, Control-IQ Technology, lyumjev
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.
Interventions
t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.
Sponsors
Eli Lilly and Company
Jaeb Center for Health Research
Tandem Diabetes Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 80 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe Hypoglycemia | 15 weeks | Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study |
| Diabetic Ketoacidosis | 15 weeks | Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor. |
| Unanticipated Adverse Device Effects | 15 weeks | Number of unanticipated adverse device effects (UADE) events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Overall Percent Time Less Than 70 mg/dL | 15 weeks | CGM overall percent time less than 70 mg/dL |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | 15 weeks | CGM percent time in range between 70-180 mg/dL, nighttime only (12:00 AM - 5:59 AM) |
| Overall Percent Time in Range Between 70-140 mg/dL | 15 weeks | Overall CGM percent time in range between 70-140 mg/dL |
| Percent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | 15 weeks | CGM percent time in range between 70-140 mg/dL, daytime only (6:00 AM - 11:59 PM) |
| Percent Time in Range Between 70-140 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | 15 weeks | CGM percent time in range between 70-140 mg/dL, nighttime only (12:00 AM - 5:59 AM) |
| Overall Percent Time in Range Greater Than 180 mg/dL | 15 weeks | Overall CGM percent time in range greater than 180 mg/dL |
| Percent Time in Range Greater Than 180 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | 15 weeks | CGM percent time in range greater than 180 mg/dL, daytime only (6:00 AM - 11:59 PM) |
| CGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM) | 15 weeks | 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) |
| CGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM) | 15 weeks | 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) |
| Overall CGM Hypoglycemia Events Per Week | 15 weeks | Overall CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL |
| CGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM) | 15 weeks | 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) |
| CGM Hypoglycemia Events Per Week, Nighttime Only (12:00 AM - 5:59 AM) | 15 weeks | 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) |
| Overall Mean Glucose | 15 weeks | Overall CGM mean glucose mg/dL |
| Mean Glucose, Daytime Only (6:00 AM - 11:59 PM) | 15 weeks | CGM mean glucose mg/dL, daytime only (6:00 AM - 11:59 PM) |
| Mean Glucose, Nighttime Only (12:00 AM - 5:59 AM) | 15 weeks | CGM mean glucose mg/dL, nighttime only (12:00 AM - 5:59 AM) |
| Coefficient of Variation, Overall | 15 weeks | CGM measured Coefficient of Variation, Overall |
| Coefficient of Variation, Daytime Only (6:00 AM - 11:59 PM) | 15 weeks | CGM measured Coefficient of Variation, daytime only (6:00 AM - 11:59 PM) |
| Coefficient of Variation, Nighttime Only (12:00 AM - 5:59 AM) | 15 weeks | CGM measured Coefficient of Variation, nighttime only (12:00 AM - 5:59 AM) |
| Standard Deviation of All Glucose Values, Overall (24 Hour Day) | 15 weeks | 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. |
| Standard Deviation of All Glucose Values, Daytime Only (6:00 AM - 11:59 PM) | 15 weeks | 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. |
| Standard Deviation of All Glucose Values, Nighttime Only (12:00 AM - 5:59 AM) | 15 weeks | 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. |
| Postprandial Percent Time in Range Between 70-180 mg/dL, Through 4 Hours After Each Meal | during 4 hour postprandial period after each meal, up to 15 weeks | 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. |
| Percent Time in Range Greater Than 180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | 15 weeks | CGM percent time in range greater than 180 mg/dL, nighttime only (12:00 AM - 5:59 AM) |
| Postprandial Percent Time Greater Than 180 mg/dL, Through 4 Hours After Each Meal | during 4 hour postprandial period after each meal, up to 15 weeks | 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. |
| Postprandial Percent Time Greater Than 250 mg/dL, Through 4 Hours After Each Meal | during 4 hour postprandial period after each meal, up to 15 weeks | 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. |
| Peak Postprandial Glucose, Through 4 Hours After Each Meal | during 4 hour postprandial period after each meal, up to 15 weeks | Peak postprandial glucose (mg/dL), through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study. |
| Postprandial Mean Glucose, Through 4 Hours After Each Meal | during 4 hour postprandial period after each meal, up to 15 weeks | 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. |
| Postprandial Incremental Area Under the Glucose Curve, Through 4 Hours After Each Meal | during 4 hour postprandial period after each meal, up to 15 weeks | 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. |
| Coefficient of Variation, Postprandial, Through 4 Hours After Each Meal | during 4 hour postprandial period after each meal, up to 15 weeks | 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. |
| Standard Deviation of All Glucose Values, Postprandial Through 4 Hours After Each Meal | during 4 hour postprandial period after each meal, up to 15 weeks | 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. |
| HbA1c Change From Baseline | 13 weeks | Change in HbA1c from End of Humalog Lead-in Period (End of Week 2) to End of Lyumjev Treatment Period (End of Week 15) |
| Patient Reported Outcomes: TRIM-D | 15 weeks | 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). |
| Patient Reported Outcomes: TRIM-DD | 15 weeks | 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). |
| Patient Reported Outcomes: ITSQ | 15 weeks | 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). |
| Postprandial Percent Time in Range Between 70-140 mg/dL, Through 4 Hours After Each Meal | during 4 hour postprandial period after each meal, up to 15 weeks | 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. |
| Overall Percent Time in Range Greater Than 250 mg/dL | 15 weeks | Overall CGM percent time in range greater than 250 mg/dL |
| Percent Time in Range Greater Than 250 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | 15 weeks | CGM percent time in range greater than 250 mg/dL, daytime only (6:00 AM - 11:59 PM) |
| Percent Time in Range Greater Than 250 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | 15 weeks | CGM percent time in range greater than 250 mg/dL, nighttime only (12:00 AM - 5:59 AM) |
| Overall CGM Hyperglycemic Events Per Week | 15 weeks | Overall CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within a 120 minute window |
| Overall Percent Time in Range Between 70-180 mg/dL | 15 weeks | Overall CGM percent time in range between 70-180 mg/dL |
| Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | 15 weeks | CGM percent time in range between 70-180 mg/dL, daytime only (6:00 AM - 11:59 PM) |
Countries
United States
Participant flow
Pre-assignment details
179 participants completed the Humalog run-in and initiated Lyumjev use.
Participants by arm
| Arm | Count |
|---|---|
| Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor and using Lyumjev insulin | 179 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Humalog Lead-In Period | Physician Decision | 2 |
| Humalog Lead-In Period | Protocol Violation | 1 |
| Humalog Lead-In Period | Withdrawal by Subject | 1 |
| Lyumjev Treatment Period | Physician Decision | 2 |
| Lyumjev Treatment Period | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period |
|---|---|
| Age, Categorical <=18 years | 109 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants |
| Age, Continuous | 24 years STANDARD_DEVIATION 17 |
| Diabetes Duration at Enrollment | 14 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 165 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 166 Participants |
| Region of Enrollment United States | 179 participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 183 |
| other Total, other adverse events | 127 / 183 |
| serious Total, serious adverse events | 5 / 183 |
Outcome results
Primary
Diabetic Ketoacidosis
Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.
Time frame: 15 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Diabetic Ketoacidosis | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 0 events |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Diabetic Ketoacidosis | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 0 events |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Severe Hypoglycemia | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 0 events |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Severe Hypoglycemia | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 3 events |
Primary
Unanticipated Adverse Device Effects
Number of unanticipated adverse device effects (UADE) events
Time frame: 15 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Unanticipated Adverse Device Effects | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 0 events |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Unanticipated Adverse Device Effects | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 0 events |
Secondary
Overall Percent Time Less Than 54 mg/dL
CGM overall percent time less than 54 mg/dL
Time frame: 15 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time Less Than 54 mg/dL | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 0.27 percentage of time | Standard Deviation 0.35 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time Less Than 54 mg/dL | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 0.26 percentage of time | Standard Deviation 0.27 |
Secondary
Overall Percent Time Less Than 70 mg/dL
CGM overall percent time less than 70 mg/dL
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time Less Than 70 mg/dL | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 1.4 percentage of time | Standard Deviation 1.3 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time Less Than 70 mg/dL | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 1.2 percentage of time | Standard Deviation 1 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 0.26 percentage of time | Standard Deviation 0.44 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 0.31 percentage of time | Standard Deviation 0.37 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 1.5 percentage of time | Standard Deviation 1.5 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 1.6 percentage of time | Standard Deviation 1.4 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | CGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 1.5 events per week | Standard Deviation 1.8 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | CGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 1.4 events per week | Standard Deviation 1.5 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | CGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 0.4 events per week | Standard Deviation 0.6 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | CGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 0.3 events per week | Standard Deviation 0.4 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | CGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 0.37 events per week | Standard Deviation 0.46 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | CGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 0.32 events per week | Standard Deviation 0.59 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | CGM Hypoglycemia Events Per Week, Nighttime Only (12:00 AM - 5:59 AM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 0.09 events per week | Standard Deviation 0.24 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | CGM Hypoglycemia Events Per Week, Nighttime Only (12:00 AM - 5:59 AM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 0.09 events per week | Standard Deviation 0.14 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Coefficient of Variation, Daytime Only (6:00 AM - 11:59 PM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 36 percentage of coefficient of variation | Standard Deviation 5 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Coefficient of Variation, Daytime Only (6:00 AM - 11:59 PM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 36 percentage of coefficient of variation | Standard Deviation 5 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Coefficient of Variation, Nighttime Only (12:00 AM - 5:59 AM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 32 percentage of coefficient of variation | Standard Deviation 8 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Coefficient of Variation, Nighttime Only (12:00 AM - 5:59 AM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 33 percentage of coefficient of variation | Standard Deviation 6 |
Other Pre-specified
Coefficient of Variation, Overall
CGM measured Coefficient of Variation, Overall
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Coefficient of Variation, Overall | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 36 percentage of coefficient of variation | Standard Deviation 5 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Coefficient of Variation, Overall | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 36 percentage of coefficient of variation | Standard Deviation 5 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Coefficient of Variation, Postprandial, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 36 percentage of coefficient of variation | Standard Deviation 6 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Coefficient of Variation, Postprandial, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 36 percentage of coefficient of variation | Standard Deviation 5 |
Other Pre-specified
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | HbA1c Change From Baseline | -0.1 percentage of glycated hemoglobin |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Mean Glucose, Daytime Only (6:00 AM - 11:59 PM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 171 mg/dL | Standard Deviation 27 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Mean Glucose, Daytime Only (6:00 AM - 11:59 PM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 168 mg/dL | Standard Deviation 25 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Mean Glucose, Nighttime Only (12:00 AM - 5:59 AM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 157 mg/dL | Standard Deviation 28 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Mean Glucose, Nighttime Only (12:00 AM - 5:59 AM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 156 mg/dL | Standard Deviation 23 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall CGM Hyperglycemic Events Per Week | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 1.8 events per week | Standard Deviation 1.9 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall CGM Hyperglycemic Events Per Week | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 1.6 events per week | Standard Deviation 1.6 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall CGM Hypoglycemia Events Per Week | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 0.46 events per week | Standard Deviation 0.75 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall CGM Hypoglycemia Events Per Week | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 0.49 events per week | Standard Deviation 0.55 |
Other Pre-specified
Overall Mean Glucose
Overall CGM mean glucose mg/dL
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Mean Glucose | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 167 mg/dL | Standard Deviation 26 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Mean Glucose | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 165 mg/dL | Standard Deviation 23 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time in Range Between 70-140 mg/dL | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 40 percentage of time | Standard Deviation 14 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time in Range Between 70-140 mg/dL | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 42 percentage of time | Standard Deviation 13 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time in Range Between 70-180 mg/dL | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 65 percentage of time | Standard Deviation 15 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time in Range Between 70-180 mg/dL | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 67 percentage of time | Standard Deviation 13 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time in Range Greater Than 180 mg/dL | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 32 percentage of time | Standard Deviation 13 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time in Range Greater Than 180 mg/dL | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 34 percentage of time | Standard Deviation 15 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time in Range Greater Than 250 mg/dL | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 12 percentage of time | Standard Deviation 10 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Overall Percent Time in Range Greater Than 250 mg/dL | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 11 percentage of time | Standard Deviation 8 |
Other Pre-specified
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
Population: 5 participants did not have data at the end of the Lyumjev treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Patient Reported Outcomes: ITSQ | Start of Humalog Lead-In Period (Start of Week 1) | 75 score on a scale | Standard Deviation 13 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Patient Reported Outcomes: ITSQ | Lyumjev Treatment Period (End of Week 15) | 80 score on a scale | Standard Deviation 11 |
Other Pre-specified
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
Population: 3 participants did not have data at the end of the Lyumjev treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Patient Reported Outcomes: TRIM-D | Start of Humalog Lead-In Period (Start of Week 1) | 74 score on a scale | Standard Deviation 12 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Patient Reported Outcomes: TRIM-D | Lyumjev Treatment Period (End of Week 15) | 80 score on a scale | Standard Deviation 12 |
Other Pre-specified
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
Population: 4 participants did not have data at the end of the Lyumjev treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Patient Reported Outcomes: TRIM-DD | Start of Humalog Lead-In Period (Start of Week 1) | 82 score on a scale | Standard Deviation 11 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Patient Reported Outcomes: TRIM-DD | Lyumjev Treatment Period (End of Week 15) | 86 score on a scale | Standard Deviation 12 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Peak Postprandial Glucose, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 244 mg/dL | Standard Deviation 40 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Peak Postprandial Glucose, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 241 mg/dL | Standard Deviation 38 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 38 percentage of time | Standard Deviation 14 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 40 percentage of time | Standard Deviation 13 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Between 70-140 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 47 percentage of time | Standard Deviation 20 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Between 70-140 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 49 percentage of time | Standard Deviation 18 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 62 percentage of time | Standard Deviation 15 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 64 percentage of time | Standard Deviation 14 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 72 percentage of time | Standard Deviation 18 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 75 percentage of time | Standard Deviation 15 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Greater Than 180 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 36 percentage of time | Standard Deviation 16 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Greater Than 180 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 34 percentage of time | Standard Deviation 14 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Greater Than 180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 26 percentage of time | Standard Deviation 18 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Greater Than 180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 24 percentage of time | Standard Deviation 15 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Greater Than 250 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 13 percentage of time | Standard Deviation 11 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Greater Than 250 mg/dL, Daytime Only (6:00 AM - 11:59 PM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 12 percentage of time | Standard Deviation 10 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Greater Than 250 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 9 percentage of time | Standard Deviation 9 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Percent Time in Range Greater Than 250 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 8 percentage of time | Standard Deviation 7 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Incremental Area Under the Glucose Curve, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 31 mg*hr/dL | Standard Deviation 12 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Incremental Area Under the Glucose Curve, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 30 mg*hr/dL | Standard Deviation 8 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Mean Glucose, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 180 mg/dL | Standard Deviation 32 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Mean Glucose, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 177 mg/dL | Standard Deviation 28 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time Greater Than 180 mg/dL, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 43 percentage of time | Standard Deviation 18 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time Greater Than 180 mg/dL, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 42 percentage of time | Standard Deviation 16 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time Greater Than 250 mg/dL, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 16 percentage of time | Standard Deviation 14 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time Greater Than 250 mg/dL, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 15 percentage of time | Standard Deviation 12 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time in Range Between 70-140 mg/dL, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 32 percentage of time | Standard Deviation 14 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time in Range Between 70-140 mg/dL, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 33 percentage of time | Standard Deviation 13 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time in Range Between 70-180 mg/dL, Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 55 percentage of time | Standard Deviation 17 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Postprandial Percent Time in Range Between 70-180 mg/dL, Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 57 percentage of time | Standard Deviation 16 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Standard Deviation of All Glucose Values, Daytime Only (6:00 AM - 11:59 PM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 62 mg/dL | Standard Deviation 15 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Standard Deviation of All Glucose Values, Daytime Only (6:00 AM - 11:59 PM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 61 mg/dL | Standard Deviation 14 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Standard Deviation of All Glucose Values, Nighttime Only (12:00 AM - 5:59 AM) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 52 mg/dL | Standard Deviation 18 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Standard Deviation of All Glucose Values, Nighttime Only (12:00 AM - 5:59 AM) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 52 mg/dL | Standard Deviation 15 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Standard Deviation of All Glucose Values, Overall (24 Hour Day) | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 61 mg/dL | Standard Deviation 15 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Standard Deviation of All Glucose Values, Overall (24 Hour Day) | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 60 mg/dL | Standard Deviation 14 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Standard Deviation of All Glucose Values, Postprandial Through 4 Hours After Each Meal | Humalog Lead-In Period Weeks 1-2 (2 Weeks) | 64 mg/dL | Standard Deviation 15 |
| Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin | Standard Deviation of All Glucose Values, Postprandial Through 4 Hours After Each Meal | Lyumjev Treatment Period Weeks 3-15 (13 Weeks) | 64 mg/dL | Standard Deviation 14 |