The International Diabetes Closed Loop (iDCL) Trial: Clin... | NCT03591354

ID	Type	Description	Link
UC4DK108483	U.S. NIH Grant/Contract		View source

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH
Jaeb Center for Health Research	OTHER
Tandem Diabetes Care, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Closed Loop Control (CLC)	Experimental	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 Continuous Glucose Monitor (CGM) for 3 months. Objective 1: This arm is participants who had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial) Objective 2: This arm is participants who had 6 months of sensor-augmented pump (SAP) in the primary trial (DCLP3 Pivotal Trial) Objective 3: This arm is participants who had 3 months of CLC in the extension trial (DCLP3 Extension) will continue use of the Control-IQ Technology & Dexcom G6 CGM until the product is commercially available.	Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Predictive-Low Glucose Suspend (PLGS)	Active Comparator	Participants randomized to Predictive-Low Glucose Suspend (PLGS) will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Objective 1: This arm is participants who had 6 months of PLGS in the primary trial (DCLP3 Pivotal Trial) Objective 2: This arm is not applicable to objective 2 Objective 3: This arm is participants who had 3 months of PLGS in the extension trial (DCLP3 Extension) will continue use of the Control-IQ Technology & Dexcom G6 CGM until the product is commercially available.	Device: t:slim X2 with Basal-IQ & Dexcom G6 CGM

Name	Type	Description	Arm Group Labels	Other Names
t:slim X2 with Control-IQ Technology & Dexcom G6 CGM	Device	Participants will use the Tandem t:slim X2 insulin pump with Control-IQ Technology & Dexcom G6 CGM for 3 months.	Closed Loop Control (CLC)

Measure	Description	Time Frame
Time in Target Range	The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.	13 weeks

Measure	Description	Time Frame
CGM Time Above 180	CGM-measured % above 180 mg/dL	13 weeks
CGM Mean Glucose	CGM-measured mean glucose	13 weeks

Measure	Description	Time Frame
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L	Ketone events defined as day with ketone level > 1.0 mmol/L	13 weeks
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)

Name	Affiliation	Role
Sue Brown, MD	University of Virginia	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Sansum Diabetes Research Institute		Santa Barbara	California	93105	United States
Stanford University

PubMed Identifier	Type	Citation	Retractions
35099294	Derived	Levy CJ, O'Malley G, Raghinaru D, Kudva YC, Laffel LM, Pinsker JE, Lum JW, Brown SA; iDCL Trial Research Group. Insulin Delivery and Glucose Variability Throughout the Menstrual Cycle on Closed Loop Control for Women with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):357-361. doi: 10.1089/dia.2021.0431. Epub 2022 Feb 21.

ID	Title	Description
FG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 11, 2019	Feb 14, 2022

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

Time in Target Range

The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.

Posted

Mean

Standard Deviation

percentage of time in range

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002	SAP to CLC Group	Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology & Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension. Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).

Units	Counts
Participants	OG00054 OG00155 OG00255

Title

Denominators

Categories

Title	Measurements
	OG00067.6± 12.6 OG00160.4± 17.1 OG00269± 11

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		<0.001														Superiority

Secondary

CGM Time Above 180

CGM-measured % above 180 mg/dL

Posted

Mean

Standard Deviation

percentage of time

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

CGM Mean Glucose

CGM-measured mean glucose

Posted

Mean

Standard Deviation

mg/dL

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002	SAP to CLC Group

Secondary

CGM Time Below 70

CGM-measured % below 70 mg/dL

Posted

Mean

Standard Deviation

percentage of time

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

CGM Time Below 54

CGM-measured % below 54 mg/dL

Posted

Median

Inter-Quartile Range

percentage of time

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

CGM Time in Range 70-140 mg/dL

CGM-measured % in range 70-140 mg/dL

Posted

Mean

Standard Deviation

percentage of time

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

Coefficient of Variation

CGM measured glucose variability measured with the coefficient of variation (CV)

Posted

Mean

Standard Deviation

percentage SD of Mean

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

Standard Deviation

CGM measured glucose variability measured with the standard deviation (SD)

Posted

Mean

Standard Deviation

mg/dL

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

CGM Time Below 60

CGM-measured % below 60 mg/dL

Posted

Median

Inter-Quartile Range

percentage of time

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

LBGI

Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values <1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)

Posted

Mean

Standard Deviation

index

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

CGM Hypoglycemia Events

CGM-measured events of at least 15 consecutive minutes <70 mg/dL

Posted

Median

Inter-Quartile Range

Events per Week

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

CGM Time >250

CGM-measured % >250 mg/dL

Posted

Mean

Standard Deviation

percentage of time

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002	SAP to CLC Group

Secondary

CGM Time >300

CGM-measured % >300 mg/dL

Posted

Mean

Standard Deviation

percentage of time

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002	SAP to CLC

Secondary

HBGI

High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)

Posted

Mean

Standard Deviation

index

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

HbA1c at 13 Weeks

HbA1c at 13 weeks.

Posted

Mean

Standard Deviation

% of glycated hemoglobin

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

HbA1c <7.0% at 13 Weeks

HbA1c <7.0% at 13 weeks.

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

HbA1c <7.5% at 13 Weeks

HbA1c <7.5% at 13 weeks.

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

HbA1c Change From Baseline to 13 Weeks >0.5%

HbA1c change from baseline to 13 weeks >0.5%.

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

HbA1c Change From Baseline to 13 Weeks >1.0%

HbA1c change from baseline to 13 weeks >1.0%.

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

HbA1c Relative Change From Baseline to 13 Weeks >10%

HbA1c relative change from baseline to 13 weeks >10%.

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks

HbA1c change from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks.

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

HFS-II Adult

Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)

For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia.

Adults

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

HFS-II Teen

Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)

For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses.The teen survey has a total of 25 items and the range of Total scores is 0 to 100.

Teens

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).

Secondary

HFS-II Parents

Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)

For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108.

Parent

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).

Secondary

Hyperglycemia Avoidance Scale

Hyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia.

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

Diabetes Distress Scale

Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

Hypoglycemia Confidence Scale

Hypoglycemia Confidence Scale has 9 items which are self-rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.

Reporting first item on the scale: exercise

Posted

Mean

Full Range

score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

Clarke Hypoglycemia Awareness Scores

Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)

Posted

Median

Inter-Quartile Range

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

INSPIRE Survey Scores- Adults

The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items.

Adults

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

INSPIRE Survey Scores- Teens

Teens

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).

Secondary

INSPIRE Survey Scores- Parents

Parent.

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).

Secondary

System Usability Scores (SUS)

System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

Technology Acceptance Questionnaire

Technology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance. There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185.

Posted

Mean

Standard Deviation

total score on a scale

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

Total Daily Insulin

Total Daily Insulin (units/kg)

Data not available in all participants

Posted

Median

Inter-Quartile Range

Units of insulin per kg

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

Basal:Bolus Insulin Ratio

Basal:Bolus Insulin Ratio.

Posted

Median

Inter-Quartile Range

Basal:Bolus Ratio

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Secondary

Weight

Weight (kg)

Data not available in all participants.

Posted

Median

Inter-Quartile Range

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Secondary

BMI

Body Mass Index (BMI) kg/m2

Data not available in all participants

Posted

Median

Inter-Quartile Range

kg/m^2

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

Ketone Events Defined as Day With Ketone Level >1.0 mmol/L

Ketone events defined as day with ketone level > 1.0 mmol/L

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)

CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL).

Posted

Median

Inter-Quartile Range

event rate per week

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)

CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL).

Posted

Median

Inter-Quartile Range

Event Rate per Week

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

Worsening of HbA1c From Randomization to 13 Weeks by >0.5%

Worsening of HbA1c from randomization to 13 weeks by >0.5%.

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects)

Serious adverse events with a possible or greater relationship to a study device (including anticipated and unanticipated adverse device effects).

Posted

Number

Events

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

Adverse Device Effects (ADE) That do Not Meet Criteria for SAE

Adverse device effects (ADE) that do not meet criteria for SAE.

Posted

Number

Events

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

Other Serious Adverse Events Not Related to a Study Device

Other serious adverse events not related to a study device.

Posted

Number

Events

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

Severe Hypoglycemic Events

Number of Severe Hypoglycemic events over initial 13 weeks of trial

Posted

Number

Events

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Other Pre-specified

Severe Hypoglycemic Event Rate Per 100 Person-years

Number of severe hypoglycemic events per 100 person-years over initial 13 weeks of trial

Posted

Number

Events per 100 person-years

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

Diabetic Ketoacidosis (DKA) Events

Number of DKA events over initial 13 weeks of trial

Posted

Number

Events

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
OG002

Other Pre-specified

Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years

Number of DKA events per 100 person-years over initial 13 weeks

Posted

Number

Events per 100 person-years

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	PParticipants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	PParticipants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

Any Adverse Event Rate Per 100 Person-years

Number of adverse events per 100 person-years over initial 13 weeks

Posted

Number

Events per 100 person-years

13 weeks

ID	Title	Description
OG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
OG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).

Other Pre-specified

Time in Target Range From Months 4-12

CGM time in target range 70-180mg/dL for all participants using CLC from Months 4-12.

Posted

Mean

Standard Deviation

percentage time in range

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM Time Above 180 From Months 4-12

CGM-measured % above 180mg/dL from Months 4-12

Posted

Mean

Standard Deviation

percentage of time

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM Mean Glucose From Months 4-12

CGM-measured mean glucose from Months 4-12

Posted

Mean

Standard Deviation

mg/dL

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM Time Below 70 From Months 4-12

CGM-measured % below 70 mg/dL from Months 4-12

Posted

Mean

Standard Deviation

percentage of time

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM Time Below 54 From Months 4-12

CGM-measured % time below 54mg/dL from Months 4-12

Posted

Median

Inter-Quartile Range

percentage of time

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM Time in Range 70-140 mg/dL From Months 4-12

CGM-measured % time in range 70-140mg/dL from Months 4-12

Posted

Mean

Standard Deviation

percentage of time

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

Coefficient of Variation From Months 4-12

CGM measured glucose variability measured with the coefficient of variation from Months 4-12

Posted

Mean

Standard Deviation

percentage SD of mean

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

Standard Deviation From Months 4-12

CGM measured glucose variability measured with the standard deviation (SD) from Months 4-12

Posted

Mean

Standard Deviation

mg/dL

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM Time Below 60 From Months 4-12

CGM-measured % below 60mg/dL from Months 4-12

Posted

Median

Inter-Quartile Range

percentage of time

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

LBGI From Months 4-12

LBGI from Months 4-12. Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values <1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)

Posted

Mean

Standard Deviation

index

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

HBGI From Months 4-12

HBGI from Months 4-12. High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)

Posted

Mean

Standard Deviation

index

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM Hypoglycemia Events From Months 4-12

CGM-measured events of at least 15 consecutive minutes <70mg/dL from Months 4-12

Posted

Mean

Standard Deviation

Events per Week

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM Time >250 From Months 4-12

CGM-measured % time >250 mg/dL from Months 4-12

Posted

Mean

Standard Deviation

percentage of time

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM Time >300 From Months 4-12

CGM-measured % time >300 mg/dL from Months 4-12

Posted

Mean

Standard Deviation

percentage of time

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

HbA1c at Month 6

HbA1c measured at Month 6 of this extension study

Posted

Mean

Standard Deviation

% of glycated hemoglobin

Month 6 of study

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

HbA1c at Month 9

HbA1c measured at month 9 of this extension study

Posted

Mean

Standard Deviation

% of glycated hemoglobin

Month 9 of study

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

HbA1c at Month 12

HbA1c measured at Month 12 of this extension study

Posted

Mean

Standard Deviation

% of glycated hemoglobin

Month 12 of study

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

Ketone Events Defined as Days With Ketone Level >1.0 mmol/L From Months 4-12

Ketone Events Defined as Number of Days with at least one Ketone Level >1.0 mmol/L from Months 4-12

Posted

Number

days

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM-measured Hypoglycemia Events (>15 Minutes With Glucose Concentration <54mg/dL) From Months 4-12

CGM-measured Hypoglycemia Events (>15 minutes with glucose concentration <54mg/dL) from Months 4-12 measured as a rate per week.

Posted

Median

Inter-Quartile Range

Events per Week

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

CGM-measured Hyperglycemic Events From Months 4-12

CGM-measured Hyperglycemic Events (>15 consecutive minutes with CGM glucose >300mg/dL) from Months 4-12

Posted

Median

Inter-Quartile Range

Event rate per week

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Severe Hypoglycemic Events From Months 4-12

Number of Severe Hypoglycemic Events from Months 4-12.

Posted

Number

events

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Diabetic Ketoacidosis (DKA) Events From Months 4-12

Number of Diabetic Ketoacidosis (DKA) events from Months 4-12.

Posted

Number

events

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

Other Serious Adverse Events Not Related to a Study Device From Months 4-12

Other Serious Adverse Events Not Related to a Study Device from Months 4-12.

Posted

Number

events

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

Other Pre-specified

Any Adverse Event Rate Per 100 Person-years From Months 4-12

Any Adverse Event Rate per 100 person-years from Months 4-12.

Posted

Number

events rate per 100 person-years

Months 4-12

ID	Title	Description
OG000	Closed-Loop Control (CLC) From 3 Months Until Study End	After 3 months, all participants continued or transitioned to Closed-Loop Control until study end. Specifically the initial 3 groups transitioned into one group using CLC: 1) CLC group continued CLC; 2) PLGS group transitioned to CLC and 3) the SAP to CLC group continued CLC. The timing of study end was not a fixed duration per participant and occurred following commercialization of device.

Units	Counts
Participants	OG000

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

ID	Title	Description
BG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).
BG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).
BG002	SAP to CLC Group	Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology & Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the prior Pivotal Trial. This arm was not compared to the randomized groups CLC and PLGS that were randomized during the extension. This group met Objective 2 of the study.Participants in this arm will continue to use CLC through commercial availability of the device after the 3 months extension
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Closed Loop Control (CLC)	Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial).	54	54	0	54
EG001	Predictive-Low Glucose Suspend (PLGS)	Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial).	55	55	3	55
EG002	SAP to CLC Group	Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology & Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the primary trial (DCLP3 Pivotal Trial). This arm met Objective 2 of the study and was not compared to the CLC and PLGS groups that were randomized during the extension. Participants in this arm will continue to use CLC through commercial availability of the device after the completion of the 3 months extension (Objective 3 of the trial).	55	55	2	55