Trial Outcomes & Findings for The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (NCT NCT03563313)

Results Overview

The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

26 weeks

Results posted on

2020-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	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 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.
Overall Study STARTED	112	56
Overall Study COMPLETED	112	56
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	Total n=168 Participants Total of all reporting groups
Age, Categorical <=18 years	31 Participants n=5 Participants	17 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants	39 Participants n=7 Participants	120 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 16 • n=5 Participants	33 years STANDARD_DEVIATION 17 • n=7 Participants	33 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	30 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	26 Participants n=7 Participants	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	51 Participants n=7 Participants	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	53 Participants n=7 Participants	147 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants	56 participants n=7 Participants	168 participants n=5 Participants
CGM Time in Target Range 70-180 mg/dL	61 percentage of time STANDARD_DEVIATION 17 • n=5 Participants	59 percentage of time STANDARD_DEVIATION 14 • n=7 Participants	60 percentage of time STANDARD_DEVIATION 16 • n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Time in Target Range	71 percentage of time Standard Deviation 12	59 percentage of time Standard Deviation 14	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

CGM-measured % above 180 mg/dL

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM Time Above 180	27 percentage Standard Deviation 12	38 percentage Standard Deviation 15	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

CGM-measured mean glucose

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM Mean Glucose	156 mg/dL Standard Deviation 19	170 mg/dL Standard Deviation 25	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Hemoglobin A1c measured at 26 weeks

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
HbA1c at 26 Weeks	7.06 percentage Standard Deviation 0.79	7.39 percentage Standard Deviation 0.92	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

CGM-measured % below 70 mg/dL

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM Time Below 70	1.58 percentage Standard Deviation 1.15	2.25 percentage Standard Deviation 1.46	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

CGM-measured % below 54 mg/dL

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM Time Below 54	0.29 percentage Standard Deviation 0.29	0.35 percentage Standard Deviation 0.32	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM Time in Range 70-140 mg/dL	46 percentage Standard Deviation 12	36 percentage Standard Deviation 12	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Coefficient of Variability	34 percentage SD of Mean Standard Deviation 5	36 percentage SD of Mean Standard Deviation 5	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Standard Deviation of CGM	53 mg/dL Standard Deviation 12	62 mg/dL Standard Deviation 13	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

CGM-measured % below 60 mg/dL

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM Time Below 60	0.58 percentage Standard Deviation 0.52	0.75 percentage Standard Deviation 0.61	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

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)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
LBGI	0.51 units on a scale Standard Deviation 0.29	0.65 units on a scale Standard Deviation 0.35	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM Hypoglycemia Events	3.3 events per week Standard Deviation 2.1	4.3 events per week Standard Deviation 2.7	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

CGM-measured % \>250 mg/dL

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM Time >250	7 percentage Standard Deviation 6.7	12.3 percentage Standard Deviation 10.2	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

CGM-measured % \>300 mg/dL

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM Time >300	2.4 percentage Standard Deviation 3.4	4.6 percentage Standard Deviation 6.0	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

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)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
HBGI	6.3 index Standard Deviation 3.1	9.0 index Standard Deviation 4.4	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Number of participants HbA1c \<7.0% at 26 weeks

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Number of Participants With HbA1c <7.0% at 26 Weeks	52 Participants	17 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Number of Participants with HbA1c \<7.5% at 26 weeks

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Number of Participants With HbA1c <7.5% at 26 Weeks	79 Participants	33 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

HbA1c improvement from baseline to 26 weeks \>0.5%

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%	35 Participants	6 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

HbA1c improvement from baseline to 26 weeks \>1.0%

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%	12 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

HbA1c relative improvement from baseline to 26 weeks \>10%

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
HbA1c Relative Improvement From Baseline to 26 Weeks >10%	21 percentage Standard Deviation 19	2 percentage Standard Deviation 4	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

HbA1c improvement from baseline to 26 weeks \>1.0% or HbA1c \<7.0% at 26 weeks

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks	59 Participants	17 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Population: Total Score at 26 weeks

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. The teen survey has a total of 25 items and the range of Total scores is 0 to 100. The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=80 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=39 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens n=31 Participants Survey response from a teen in CLC (14-18 years old)	SAP in Teens n=16 Participants Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC n=31 Participants Survey response from a parent of a teen in CLC	Parent of a Teen in SAP n=15 Participants Survey response from a parent of a teen in SAP
HFS-II	33 score on a scale Standard Deviation 12	38 score on a scale Standard Deviation 18	32 score on a scale Standard Deviation 10	31 score on a scale Standard Deviation 16	33 score on a scale Standard Deviation 14	36 score on a scale Standard Deviation 15

SECONDARY outcome

Timeframe: 26 weeks

Population: Total Score at 26 weeks

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.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Hyperglycemia Avoidance Scale	39 score on a scale Standard Deviation 7	37 score on a scale Standard Deviation 11	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Population: Total Score at 26 weeks

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.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Diabetes Distress Scale	1.7 score on a scale Standard Deviation 0.6	1.9 score on a scale Standard Deviation 0.8	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Population: First two items on hypoglycemia confidence scale

Hypoglycemia Confidence Scale has 20 items which are 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.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Hypoglycemia Confidence Scale Execise	2.3 score on a scale Interval 0.0 to 3.0	1.9 score on a scale Interval 0.0 to 3.0	—	—	—	—
Hypoglycemia Confidence Scale Sleeping	2.3 score on a scale Interval 1.0 to 3.0	1.9 score on a scale Interval 0.0 to 3.0	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Clarke Hypoglycemia Awareness Scores	1 score on a scale Interval 0.0 to 3.0	2 score on a scale Interval 0.0 to 3.0	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Population: Scores are measured at 26 weeks

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, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=80 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=39 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens n=31 Participants Survey response from a teen in CLC (14-18 years old)	SAP in Teens n=16 Participants Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC n=31 Participants Survey response from a parent of a teen in CLC	Parent of a Teen in SAP n=15 Participants Survey response from a parent of a teen in SAP
INSPIRE Survey Scores	87 score on a scale Standard Deviation 14	86 score on a scale Standard Deviation 13	87 score on a scale Standard Deviation 13	74 score on a scale Standard Deviation 12	87 score on a scale Standard Deviation 13	76 score on a scale Standard Deviation 12

SECONDARY outcome

Timeframe: 26 weeks

Population: Administered to CLC group only. Results from 26-week.

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

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=109 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
System Usability Scores (SUS)	87 score on a scale Standard Deviation 12	—	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Population: Administered to CLC arm only. Result from 26-weeks.

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.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Technology Acceptance Questionnaire	155 score on a scale Standard Deviation 19	—	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Total Daily Insulin (units)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Total Daily Insulin	55 units Standard Deviation 27	51 units Standard Deviation 20	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Basal:Bolus Insulin Ratio

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Basal:Bolus Insulin Ratio	1.1 ratio Standard Deviation 0.7	1.1 ratio Standard Deviation 0.8	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Weight (kg)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Weight	78.7 kilograms Standard Deviation 17.0	76.0 kilograms Standard Deviation 18.9	—	—	—	—

SECONDARY outcome

Timeframe: 26 weeks

Body Mass Index (BMI) kg/m\^2

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=111 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=55 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
BMI	26.2 kg/m^2 Standard Deviation 4.9	26.1 kg/m^2 Standard Deviation 6.1	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Severe hypoglycemia (per protocol)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Number of Participants With Severe Hypoglycemia (Per Protocol)	0 Participants	0 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Diabetic ketoacidosis (per protocol)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Number of Participants With Diabetic Ketoacidosis (Per Protocol)	1 Participants	0 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=20571 Days Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=10285 Days Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L	14 days	15 days	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)	0.4 events per week Interval 0.1 to 0.9	0.5 events per week Interval 0.2 to 0.9	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

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

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)	1.2 events per week Interval 0.4 to 2.6	2.7 events per week Interval 1.1 to 4.6	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

BG-measured hypoglycemic events (one BG record \<54 mg/dL)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=20571 Days Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=10285 Days Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
BG-measured Hypoglycemic Events (One BG Record <54 mg/dL)	129 days	72 days	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

BG-measured hyperglycemic events (one BG record \>350 mg/dL)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=20571 Days Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=10285 Days Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
BG-measured Hyperglycemic Events (One BG Record >350 mg/dL)	243 days	181 days	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Worsening of HbA1c from baseline to 26 weeks by \>0.5%

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Worsening of HbA1c From Baseline to 26 Weeks by >0.5%	8 Participants	5 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Population: Other Serious Adverse Events that do not include DKA or Severe Hypoglycemia

Other serious adverse events (SAE) and serious adverse device events (SADE)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE) Concussion	1 participants	0 participants	—	—	—	—
Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE) Otitis	1 participants	0 participants	—	—	—	—
Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE) Cardiac Bypass Surgery	1 participants	0 participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Adverse device effects (ADE)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Adverse Device Effects (ADE)	11 Participants	0 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Population: Study Device

Unanticipated adverse device effects (UADE)

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Unanticipated Adverse Device Effects (UADE)	1 Unanticipated Adverse Device Effects	0 Unanticipated Adverse Device Effects	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Number of Participants With SH Events	0 Participants	0 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
SH Event Rate Per 100 Person-years	0 rate per 100 person-years	0 rate per 100 person-years	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Number of Participants With DKA Events	1 Participants	0 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
DKA Event Rate Per 100 Person-years	1.8 rate per 100 person-years	0 rate per 100 person-years	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

For this outcome, the adverse event rate per 100 person-years calculated as a rate.

Outcome measures

Outcome measures
Measure	Closed Loop Control (CLC) n=112 Participants Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 Participants Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.	CLC in Teens Survey response from a teen in CLC (14-18 years old)	SAP in Teens Survey response from a Teen in the SAP group (ages 14-18).	Parent of Teen in CLC Survey response from a parent of a teen in CLC	Parent of a Teen in SAP Survey response from a parent of a teen in SAP
Any Adverse Event Rate Per 100 Person-years	30.2 events per 100 person-yr	7.1 events per 100 person-yr	—	—	—	—

Adverse Events

Closed Loop Control (CLC)

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Sensor-Augmented Pump (SAP)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Closed Loop Control (CLC) n=112 participants at risk Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 participants at risk Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.
Endocrine disorders Diabetic Ketoacidosis	0.89% 1/112 • Number of events 1 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.	0.00% 0/56 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.
Nervous system disorders Concussion	0.89% 1/112 • Number of events 1 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.	0.00% 0/56 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.
Ear and labyrinth disorders Otitis	0.89% 1/112 • Number of events 1 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.	0.00% 0/56 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.
Cardiac disorders Cardiac Bypass Surgery	0.89% 1/112 • Number of events 1 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.	0.00% 0/56 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.

Other adverse events

Other adverse events
Measure	Closed Loop Control (CLC) n=112 participants at risk Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM: Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.	Sensor-Augmented Pump (SAP) n=56 participants at risk Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months. Sensor-augmented pump (SAP): Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.
Endocrine disorders Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis	10.7% 12/112 • Number of events 13 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.	3.6% 2/56 • Number of events 2 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.

Additional Information

Sue Brown, MD

University of Virginia

Phone: 434-962-0602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place