Trial Outcomes & Findings for 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 (NCT NCT05403502)
NCT ID: NCT05403502
Last Updated: 2024-07-26
Results Overview
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
183 participants
Primary outcome timeframe
15 weeks
Results posted on
2024-07-26
Participant Flow
179 participants completed the Humalog run-in and initiated Lyumjev use.
Participant milestones
| Measure |
Users of Tandem t:Slim X2 Insulin Pump With Control-IQ 1.5 Technology
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 who progressed to the Lyumjev Treatment Period after participating in the Humalog Lead-In Period.
|
|---|---|
|
Humalog Lead-In Period
STARTED
|
183
|
|
Humalog Lead-In Period
COMPLETED
|
179
|
|
Humalog Lead-In Period
NOT COMPLETED
|
4
|
|
Lyumjev Treatment Period
STARTED
|
179
|
|
Lyumjev Treatment Period
COMPLETED
|
173
|
|
Lyumjev Treatment Period
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Users of Tandem t:Slim X2 Insulin Pump With Control-IQ 1.5 Technology
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 who progressed to the Lyumjev Treatment Period after participating in the Humalog Lead-In Period.
|
|---|---|
|
Humalog Lead-In Period
Withdrawal by Subject
|
1
|
|
Humalog Lead-In Period
Physician Decision
|
2
|
|
Humalog Lead-In Period
Protocol Violation
|
1
|
|
Lyumjev Treatment Period
Withdrawal by Subject
|
4
|
|
Lyumjev Treatment Period
Physician Decision
|
2
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period
n=179 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
109 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
24 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
179 participants
n=5 Participants
|
|
Diabetes Duration at Enrollment
|
14 years
STANDARD_DEVIATION 13 • n=5 Participants
|
PRIMARY outcome
Timeframe: 15 weeksNumber of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Severe Hypoglycemia
Humalog Lead-In Period Weeks 1-2 (2 Weeks)
|
0 events
|
|
Severe Hypoglycemia
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)
|
3 events
|
PRIMARY outcome
Timeframe: 15 weeksNumber of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Diabetic Ketoacidosis
Humalog Lead-In Period Weeks 1-2 (2 Weeks)
|
0 events
|
|
Diabetic Ketoacidosis
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)
|
0 events
|
PRIMARY outcome
Timeframe: 15 weeksNumber of unanticipated adverse device effects (UADE) events
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Unanticipated Adverse Device Effects
Humalog Lead-In Period Weeks 1-2 (2 Weeks)
|
0 events
|
|
Unanticipated Adverse Device Effects
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)
|
0 events
|
SECONDARY outcome
Timeframe: 15 WeeksCGM overall percent time less than 54 mg/dL
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksCGM 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM overall percent time less than 70 mg/dL
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
Overall Percent Time Less Than 70 mg/dL
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)
|
1.2 percentage of time
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksCGM 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksOverall CGM percent time in range between 70-180 mg/dL
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM percent time in range between 70-180 mg/dL, daytime only (6:00 AM - 11:59 PM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM percent time in range between 70-180 mg/dL, nighttime only (12:00 AM - 5:59 AM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksOverall CGM percent time in range between 70-140 mg/dL
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM percent time in range between 70-140 mg/dL, daytime only (6:00 AM - 11:59 PM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM percent time in range between 70-140 mg/dL, nighttime only (12:00 AM - 5:59 AM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksOverall CGM percent time in range greater than 180 mg/dL
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 weeksCGM percent time in range greater than 180 mg/dL, daytime only (6:00 AM - 11:59 PM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM percent time in range greater than 180 mg/dL, nighttime only (12:00 AM - 5:59 AM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksOverall CGM percent time in range greater than 250 mg/dL
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM percent time in range greater than 250 mg/dL, daytime only (6:00 AM - 11:59 PM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM percent time in range greater than 250 mg/dL, nighttime only (12:00 AM - 5:59 AM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksOverall CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within a 120 minute window
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Overall CGM Hyperglycemic Events Per Week
Humalog Lead-In Period Weeks 1-2 (2 Weeks)
|
1.8 events per week
Standard Deviation 1.9
|
|
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 outcome
Timeframe: 15 weeksCGM 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)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM 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)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 weeksOverall CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Overall CGM Hypoglycemia Events Per Week
Humalog Lead-In Period Weeks 1-2 (2 Weeks)
|
0.46 events per week
Standard Deviation 0.75
|
|
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 outcome
Timeframe: 15 weeksCGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, daytime only (6:00 AM - 11:59 PM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 weeksCGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, nighttime only (12:00 AM - 5:59 AM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksOverall CGM mean glucose mg/dL
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Overall Mean Glucose
Humalog Lead-In Period Weeks 1-2 (2 Weeks)
|
167 mg/dL
Standard Deviation 26
|
|
Overall Mean Glucose
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)
|
165 mg/dL
Standard Deviation 23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 weeksCGM mean glucose mg/dL, daytime only (6:00 AM - 11:59 PM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM mean glucose mg/dL, nighttime only (12:00 AM - 5:59 AM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM measured Coefficient of Variation, Overall
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Coefficient of Variation, Overall
Humalog Lead-In Period Weeks 1-2 (2 Weeks)
|
36 percentage of coefficient of variation
Standard Deviation 5
|
|
Coefficient of Variation, Overall
Lyumjev Treatment Period Weeks 3-15 (13 Weeks)
|
36 percentage of coefficient of variation
Standard Deviation 5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 weeksCGM measured Coefficient of Variation, daytime only (6:00 AM - 11:59 PM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM measured Coefficient of Variation, nighttime only (12:00 AM - 5:59 AM)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM measured Standard Deviation of all glucose values (mg/dL), Overall ( 24 Hour Day). Standard Deviation of Mean Glucose is shown separately in Outcome 26.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 15 weeksCGM 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksPostprandial 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksPostprandial 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksPostprandial 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksPostprandial 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksPeak postprandial glucose (mg/dL), through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Peak Postprandial Glucose, Through 4 Hours After Each Meal
Humalog Lead-In Period Weeks 1-2 (2 Weeks)
|
244 mg/dL
Standard Deviation 40
|
|
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 outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksPostprandial CGM mean glucose (mg/dL), through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Postprandial Mean Glucose, Through 4 Hours After Each Meal
Humalog Lead-In Period Weeks 1-2 (2 Weeks)
|
180 mg/dL
Standard Deviation 32
|
|
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 outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksCGM 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksCGM measured Coefficient of Variation, Postprandial, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: during 4 hour postprandial period after each meal, up to 15 weeksCGM 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.
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=174 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 13 weeksChange in HbA1c from End of Humalog Lead-in Period (End of Week 2) to End of Lyumjev Treatment Period (End of Week 15)
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=172 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
HbA1c Change From Baseline
|
-0.1 percentage of glycated hemoglobin
Interval -0.2 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 weeksPopulation: 3 participants did not have data at the end of the Lyumjev treatment period.
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).
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=176 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Patient Reported Outcomes: TRIM-D
Start of Humalog Lead-In Period (Start of Week 1)
|
74 score on a scale
Standard Deviation 12
|
|
Patient Reported Outcomes: TRIM-D
Lyumjev Treatment Period (End of Week 15)
|
80 score on a scale
Standard Deviation 12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 weeksPopulation: 4 participants did not have data at the end of the Lyumjev treatment period.
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).
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=178 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Patient Reported Outcomes: TRIM-DD
Start of Humalog Lead-In Period (Start of Week 1)
|
82 score on a scale
Standard Deviation 11
|
|
Patient Reported Outcomes: TRIM-DD
Lyumjev Treatment Period (End of Week 15)
|
86 score on a scale
Standard Deviation 12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 weeksPopulation: 5 participants did not have data at the end of the Lyumjev treatment period.
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).
Outcome measures
| Measure |
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin
n=179 Participants
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 who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.
|
|---|---|
|
Patient Reported Outcomes: ITSQ
Start of Humalog Lead-In Period (Start of Week 1)
|
75 score on a scale
Standard Deviation 13
|
|
Patient Reported Outcomes: ITSQ
Lyumjev Treatment Period (End of Week 15)
|
80 score on a scale
Standard Deviation 11
|
Adverse Events
t:Slim X2 Insulin Pump With Control-IQ Technology Utilizing Insulin Lyumjev®
Serious events: 5 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology Utilizing Insulin Lyumjev®
n=183 participants at risk
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 for \~16 day Humalog Lead-In period and Lyumjev insulin for 3-months of outpatient use.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other Serious Adverse Event
|
0.55%
1/183 • Number of events 1 • 15 weeks
All participants were in the same arm, first completing 2 weeks of Humalog use, and then 13 weeks of Lyumjev use with Control-IQ technology v1.5. Adverse events are noted in which treatment period the event occurred.
|
|
Infections and infestations
Other Serious Adverse Event
|
0.55%
1/183 • Number of events 1 • 15 weeks
All participants were in the same arm, first completing 2 weeks of Humalog use, and then 13 weeks of Lyumjev use with Control-IQ technology v1.5. Adverse events are noted in which treatment period the event occurred.
|
|
Endocrine disorders
Severe Hypoglycemia
|
1.6%
3/183 • Number of events 3 • 15 weeks
All participants were in the same arm, first completing 2 weeks of Humalog use, and then 13 weeks of Lyumjev use with Control-IQ technology v1.5. Adverse events are noted in which treatment period the event occurred.
|
|
Endocrine disorders
Diabetic Ketoacidosis (DKA)
|
0.00%
0/183 • 15 weeks
All participants were in the same arm, first completing 2 weeks of Humalog use, and then 13 weeks of Lyumjev use with Control-IQ technology v1.5. Adverse events are noted in which treatment period the event occurred.
|
Other adverse events
| Measure |
t:Slim X2 Insulin Pump With Control-IQ Technology Utilizing Insulin Lyumjev®
n=183 participants at risk
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 for \~16 day Humalog Lead-In period and Lyumjev insulin for 3-months of outpatient use.
|
|---|---|
|
Endocrine disorders
Hyperglycemia with or without ketosis not related to the study device
|
2.2%
4/183 • Number of events 4 • 15 weeks
All participants were in the same arm, first completing 2 weeks of Humalog use, and then 13 weeks of Lyumjev use with Control-IQ technology v1.5. Adverse events are noted in which treatment period the event occurred.
|
|
Endocrine disorders
Hyperglycemia with or without ketosis related to study device
|
3.8%
7/183 • Number of events 8 • 15 weeks
All participants were in the same arm, first completing 2 weeks of Humalog use, and then 13 weeks of Lyumjev use with Control-IQ technology v1.5. Adverse events are noted in which treatment period the event occurred.
|
|
General disorders
Nonglycemic adverse events
|
10.4%
19/183 • Number of events 21 • 15 weeks
All participants were in the same arm, first completing 2 weeks of Humalog use, and then 13 weeks of Lyumjev use with Control-IQ technology v1.5. Adverse events are noted in which treatment period the event occurred.
|
|
Endocrine disorders
Nonsevere Hypoglycemia
|
0.00%
0/183 • 15 weeks
All participants were in the same arm, first completing 2 weeks of Humalog use, and then 13 weeks of Lyumjev use with Control-IQ technology v1.5. Adverse events are noted in which treatment period the event occurred.
|
Additional Information
Sr. Supervisor of Clinical Operations
Tandem Diabetes Care
Phone: +18583666900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place