Safety Evaluation of an Advanced Hybrid Closed Loop Syste... | NCT05403502

Name	Class
Eli Lilly and Company	INDUSTRY
Jaeb Center for Health Research	OTHER

Label	Type	Description	Intervention Names
t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®	Experimental	Current Control-IQ technology users with type 1 diabetes, age 6-80, will use the t:slim X2 insulin pump with Control-IQ technology 1.5 and Lyumjev insulin for 3-months of outpatient use.	Device: t:slim X2 insulin pump with Control-IQ technology 1.5

Name	Type	Description	Arm Group Labels	Other Names
t:slim X2 insulin pump with Control-IQ technology 1.5	Device	t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severe Hypoglycemia	Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study	15 weeks
Diabetic Ketoacidosis	Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.	15 weeks
Unanticipated Adverse Device Effects	Number of unanticipated adverse device effects (UADE) events	15 weeks

Secondary Outcomes

Measure	Description	Time Frame
Overall Percent Time Less Than 54 mg/dL	CGM overall percent time less than 54 mg/dL	15 Weeks
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.

Other Outcomes

Measure	Description	Time Frame
Overall Percent Time in Range Between 70-180 mg/dL	Overall CGM percent time in range between 70-180 mg/dL	15 weeks
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)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 6 to <81 years
Diagnosis of type 1 diabetes for at least 1 year
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
Total daily insulin dose (TDD) at least 2 U/day
HbA1c < 10.5%
Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation.
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.
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.
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.
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.
Participant and/or parent/legal guardian have the ability to read and understand English

Exclusion Criteria:

More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
Inpatient psychiatric treatment in the past 6 months
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.
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.
Adults lacking the capacity to provide consent and/or follow study procedures in the opinion of the investigator
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).
Hemophilia or any other bleeding disorder
Hemoglobinopathy
History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
History of allergic reaction to Humalog or Lyumjev
Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
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)
Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
History of adrenal insufficiency
History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
History of gastroparesis
A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
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

Name	Affiliation	Role
Jordan Pinsker, MD	Tandem Diabetes Care	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Orange County		Orange	California	92868	United States
Stanford University

PubMed Identifier	Type	Citation	Retractions
38696672	Result	Levy CJ, Bailey R, Laffel LM, Forlenza G, DiMeglio LA, Hughes MS, Brown SA, Aleppo G, Bhargava A, Shah VN, Clements MA, Kipnes M, Bruggeman B, Daniels M, Rodriguez H, Calhoun P, Lum JW, Sasson-Katchalski R, Pinsker JE, Pollom R, Beck RW; TL1 Study Group. Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):652-660. doi: 10.1089/dia.2024.0048. Epub 2024 May 22.

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 13, 2022	Jan 19, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Severe Hypoglycemia

Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study

Posted

Number

events

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

Title

Denominators

Categories

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Title	Measurements
	OG0000

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Title	Measurements
	OG0003

Primary

Diabetic Ketoacidosis

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

Posted

Number

events

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

Primary

Unanticipated Adverse Device Effects

Number of unanticipated adverse device effects (UADE) events

Posted

Number

events

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

Secondary

Overall Percent Time Less Than 54 mg/dL

CGM overall percent time less than 54 mg/dL

Posted

Mean

Standard Deviation

percentage of time

15 Weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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.

Posted

Mean

Standard Deviation

percentage of time

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

Secondary

Overall Percent Time Less Than 70 mg/dL

CGM overall percent time less than 70 mg/dL

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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.

Posted

Mean

Standard Deviation

percentage of time

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

Other Pre-specified

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

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

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

Other Pre-specified

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

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

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

Other Pre-specified

Overall Percent Time in Range Greater Than 180 mg/dL

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

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

Other Pre-specified

Overall Percent Time in Range Greater Than 250 mg/dL

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

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of time

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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

Posted

Mean

Standard Deviation

events per week

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

events per week

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

events per week

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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

Posted

Mean

Standard Deviation

events per week

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

events per week

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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)

Posted

Mean

Standard Deviation

events per week

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

Other Pre-specified

Overall Mean Glucose

Overall CGM mean glucose mg/dL

Posted

Mean

Standard Deviation

mg/dL

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

mg/dL

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

mg/dL

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

Other Pre-specified

Coefficient of Variation, Overall

CGM measured Coefficient of Variation, Overall

Posted

Mean

Standard Deviation

percentage of coefficient of variation

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of coefficient of variation

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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)

Posted

Mean

Standard Deviation

percentage of coefficient of variation

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000179

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.

Posted

Mean

Standard Deviation

mg/dL

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

mg/dL

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

mg/dL

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

percentage of time

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

percentage of time

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

percentage of time

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

percentage of time

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

mg/dL

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

mg/dL

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

mg*hr/dL

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

percentage of coefficient of variation

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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.

Posted

Mean

Standard Deviation

mg/dL

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

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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)

Posted

Mean

95% Confidence Interval

percentage of glycated hemoglobin

13 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000172

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).

3 participants did not have data at the end of the Lyumjev treatment period.

Posted

Mean

Standard Deviation

score on a scale

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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).

4 participants did not have data at the end of the Lyumjev treatment period.

Posted

Mean

Standard Deviation

score on a scale

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

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).

5 participants did not have data at the end of the Lyumjev treatment period.

Posted

Mean

Standard Deviation

score on a scale

15 weeks

ID	Title	Description
OG000	Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	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.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Hyperglycemia with or without ketosis not related to the study device	Endocrine disorders	Systematic Assessment	Lyumjev Treatment Period	EG0006 events5 affected183 at risk
Hyperglycemia with or without ketosis not related to the study device	Endocrine disorders	Systematic Assessment	Humalog Lead-In Period	EG0004 events4 affected183 at risk
Hyperglycemia with or without ketosis related to study device	Endocrine disorders	Systematic Assessment	Lyumjev Treatment Period	EG00040 events32 affected183 at risk
Hyperglycemia with or without ketosis related to study device	Endocrine disorders	Systematic Assessment	Humalog Lead-In Period	EG0008 events7 affected183 at risk
Nonglycemic adverse events	General disorders	Systematic Assessment	Lyumjev Treatment Period	EG000134 events81 affected183 at risk
Nonglycemic adverse events	General disorders	Systematic Assessment	Humalog Lead-In Period	EG00021 events19 affected183 at risk
Nonsevere Hypoglycemia	Endocrine disorders	Systematic Assessment	Humalog Lead-In Period	EG0000 events0 affected183 at risk
Nonsevere Hypoglycemia	Endocrine disorders	Systematic Assessment	Lyumjev Treatment Period	EG0000 events0 affected183 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Term	Organ System	Assessment Type	Notes	Statistical Information
Other Serious Adverse Event	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	Diagnosis of Breast Cancer in Lyumjev Treatment Period	EG0001 events1 affected183 at risk
Other Serious Adverse Event	Infections and infestations	Systematic Assessment	Diagnosis of hypovolemic shock, positive strep culture in Lyumjev Treatment Period	EG0001 events1 affected183 at risk
Severe Hypoglycemia	Endocrine disorders	Systematic Assessment	Requiring third party assistance associated with seizure or loss of consciousness, in Lyumjev Treatment Period	EG0003 events3 affected183 at risk
Diabetic Ketoacidosis (DKA)	Endocrine disorders	Systematic Assessment		EG0000 events0 affected183 at risk