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The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563313
Recruitment Status : Completed
First Posted : June 20, 2018
Results First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tandem Diabetes Care, Inc.
DexCom, Inc.
Roche Diagnostics
Information provided by (Responsible Party):
Sue Brown, University of Virginia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Type 1 Diabetes Mellitus
Interventions Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Device: Sensor-augmented pump (SAP)
Enrollment 168
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 112 56
Completed 112 56
Not Completed 0 0
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 112 56 168
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 56 participants 168 participants
<=18 years
31
  27.7%
17
  30.4%
48
  28.6%
Between 18 and 65 years
81
  72.3%
39
  69.6%
120
  71.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 56 participants 168 participants
33  (16) 33  (17) 33  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 56 participants 168 participants
Female
54
  48.2%
30
  53.6%
84
  50.0%
Male
58
  51.8%
26
  46.4%
84
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 56 participants 168 participants
Hispanic or Latino
13
  11.6%
5
   8.9%
18
  10.7%
Not Hispanic or Latino
99
  88.4%
51
  91.1%
150
  89.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 56 participants 168 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   2.7%
2
   3.6%
5
   3.0%
Native Hawaiian or Other Pacific Islander
1
   0.9%
0
   0.0%
1
   0.6%
Black or African American
4
   3.6%
0
   0.0%
4
   2.4%
White
94
  83.9%
53
  94.6%
147
  87.5%
More than one race
7
   6.3%
1
   1.8%
8
   4.8%
Unknown or Not Reported
3
   2.7%
0
   0.0%
3
   1.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 112 participants 56 participants 168 participants
112 56 168
CGM Time in Target Range 70-180 mg/dL   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of time
Number Analyzed 112 participants 56 participants 168 participants
61  (17) 59  (14) 60  (16)
[1]
Measure Description: CGM percentage of time in target range measured over 2-week baseline.
1.Primary Outcome
Title Time in Target Range
Hide Description The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage of time
71  (12) 59  (14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title CGM Time Above 180
Hide Description CGM-measured % above 180 mg/dL
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage
27  (12) 38  (15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title CGM Mean Glucose
Hide Description CGM-measured mean glucose
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: mg/dL
156  (19) 170  (25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title HbA1c at 26 Weeks
Hide Description Hemoglobin A1c measured at 26 weeks
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage
7.06  (0.79) 7.39  (0.92)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title CGM Time Below 70
Hide Description CGM-measured % below 70 mg/dL
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage
1.58  (1.15) 2.25  (1.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title CGM Time Below 54
Hide Description CGM-measured % below 54 mg/dL
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage
0.29  (0.29) 0.35  (0.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title CGM Time in Range 70-140 mg/dL
Hide Description CGM-measured % in range 70-140 mg/dL
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage
46  (12) 36  (12)
8.Secondary Outcome
Title Coefficient of Variability
Hide Description CGM measured glucose variability measured with the coefficient of variation (CV)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage SD of Mean
34  (5) 36  (5)
9.Secondary Outcome
Title Standard Deviation of CGM
Hide Description CGM measured glucose variability measured with the standard deviation (SD)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: mg/dL
53  (12) 62  (13)
10.Secondary Outcome
Title CGM Time Below 60
Hide Description CGM-measured % below 60 mg/dL
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage
0.58  (0.52) 0.75  (0.61)
11.Secondary Outcome
Title LBGI
Hide Description 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)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.51  (0.29) 0.65  (0.35)
12.Secondary Outcome
Title CGM Hypoglycemia Events
Hide Description CGM-measured events of at least 15 consecutive minutes <70mg/dL per week
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: events per week
3.3  (2.1) 4.3  (2.7)
13.Secondary Outcome
Title CGM Time >250
Hide Description CGM-measured % >250 mg/dL
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage
7  (6.7) 12.3  (10.2)
14.Secondary Outcome
Title CGM Time >300
Hide Description CGM-measured % >300 mg/dL
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage
2.4  (3.4) 4.6  (6.0)
15.Secondary Outcome
Title HBGI
Hide Description 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)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: index
6.3  (3.1) 9.0  (4.4)
16.Secondary Outcome
Title Number of Participants With HbA1c <7.0% at 26 Weeks
Hide Description Number of participants HbA1c <7.0% at 26 weeks
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Measure Type: Count of Participants
Unit of Measure: Participants
52
  46.8%
17
  30.9%
17.Secondary Outcome
Title Number of Participants With HbA1c <7.5% at 26 Weeks
Hide Description Number of Participants with HbA1c <7.5% at 26 weeks
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Measure Type: Count of Participants
Unit of Measure: Participants
79
  71.2%
33
  60.0%
18.Secondary Outcome
Title Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%
Hide Description HbA1c improvement from baseline to 26 weeks >0.5%
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Count of Participants
Unit of Measure: Participants
35
  31.3%
6
  10.7%
19.Secondary Outcome
Title Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%
Hide Description HbA1c improvement from baseline to 26 weeks >1.0%
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Count of Participants
Unit of Measure: Participants
12
  10.7%
0
   0.0%
20.Secondary Outcome
Title HbA1c Relative Improvement From Baseline to 26 Weeks >10%
Hide Description HbA1c relative improvement from baseline to 26 weeks >10%
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Mean (Standard Deviation)
Unit of Measure: percentage
21  (19) 2  (4)
21.Secondary Outcome
Title Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks
Hide Description HbA1c improvement from baseline to 26 weeks >1.0% or HbA1c <7.0% at 26 weeks
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Count of Participants
Unit of Measure: Participants
59
  52.7%
17
  30.4%
22.Secondary Outcome
Title HFS-II
Hide Description 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.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total Score at 26 weeks
Arm/Group Title Closed Loop Control (CLC) in Adults Sensor-Augmented Pump (SAP) in Adults CLC in Teens SAP in Teens Parent of Teen in CLC Parent of a Teen in SAP
Hide Arm/Group Description:

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.

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.

Survey response from a teen in CLC (14-18 years old)
Survey response from a Teen in the SAP group (ages 14-18).
Survey response from a parent of a teen in CLC
Survey response from a parent of a teen in SAP
Overall Number of Participants Analyzed 80 39 31 16 31 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
33  (12) 38  (18) 32  (10) 31  (16) 33  (14) 36  (15)
23.Secondary Outcome
Title Hyperglycemia Avoidance Scale
Hide Description 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.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total Score at 26 weeks
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Mean (Standard Deviation)
Unit of Measure: score on a scale
39  (7) 37  (11)
24.Secondary Outcome
Title Diabetes Distress Scale
Hide Description 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.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total Score at 26 weeks
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.7  (0.6) 1.9  (0.8)
25.Secondary Outcome
Title Hypoglycemia Confidence Scale
Hide Description 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.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
First two items on hypoglycemia confidence scale
Arm/Group Title Closed Loop Control (CLC) in Adults Sensor-Augmented Pump (SAP) in Adults
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Mean (Full Range)
Unit of Measure: score on a scale
Execise
2.3
(0 to 3)
1.9
(0 to 3)
Sleeping
2.3
(1 to 3)
1.9
(0 to 3)
26.Secondary Outcome
Title Clarke Hypoglycemia Awareness Scores
Hide Description Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
1
(0 to 3)
2
(0 to 3)
27.Secondary Outcome
Title INSPIRE Survey Scores
Hide Description 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.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Scores are measured at 26 weeks
Arm/Group Title Closed Loop Control (CLC) in Adults Sensor-Augmented Pump (SAP) in Adults CLC in Teens SAP in Teens Parent of Teen in CLC Parent of a Teen in SAP
Hide Arm/Group Description:

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.

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.

Survey response from a teen in CLC (14-18 years old)
Survey response from a Teen in the SAP group (ages 14-18).
Survey response from a parent of a teen in CLC
Survey response from a parent of a teen in SAP
Overall Number of Participants Analyzed 80 39 31 16 31 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
87  (14) 86  (13) 87  (13) 74  (12) 87  (13) 76  (12)
28.Secondary Outcome
Title System Usability Scores (SUS)
Hide Description System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Administered to CLC group only. Results from 26-week.
Arm/Group Title Closed Loop Control (CLC)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 109
Mean (Standard Deviation)
Unit of Measure: score on a scale
87  (12)
29.Secondary Outcome
Title Technology Acceptance Questionnaire
Hide Description 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.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Administered to CLC arm only. Result from 26-weeks.
Arm/Group Title Closed Loop Control (CLC)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: score on a scale
155  (19)
30.Secondary Outcome
Title Total Daily Insulin
Hide Description Total Daily Insulin (units)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Mean (Standard Deviation)
Unit of Measure: units
55  (27) 51  (20)
31.Secondary Outcome
Title Basal:Bolus Insulin Ratio
Hide Description Basal:Bolus Insulin Ratio
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Mean (Standard Deviation)
Unit of Measure: ratio
1.1  (0.7) 1.1  (0.8)
32.Secondary Outcome
Title Weight
Hide Description Weight (kg)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Mean (Standard Deviation)
Unit of Measure: kilograms
78.7  (17.0) 76.0  (18.9)
33.Secondary Outcome
Title BMI
Hide Description Body Mass Index (BMI) kg/m^2
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 111 55
Mean (Standard Deviation)
Unit of Measure: kg/m^2
26.2  (4.9) 26.1  (6.1)
34.Other Pre-specified Outcome
Title Number of Participants With Severe Hypoglycemia (Per Protocol)
Hide Description Severe hypoglycemia (per protocol)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
35.Other Pre-specified Outcome
Title Number of Participants With Diabetic Ketoacidosis (Per Protocol)
Hide Description Diabetic ketoacidosis (per protocol)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.9%
0
   0.0%
36.Other Pre-specified Outcome
Title Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
Hide Description Ketone events defined as day with ketone level >1.0 mmol/L
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Overall Number of Units Analyzed
Type of Units Analyzed: Days
20571 10285
Measure Type: Number
Unit of Measure: days
14 15
37.Other Pre-specified Outcome
Title CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
Hide Description CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Median (Inter-Quartile Range)
Unit of Measure: events per week
0.4
(0.1 to 0.9)
0.5
(0.2 to 0.9)
38.Other Pre-specified Outcome
Title CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
Hide Description CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Median (Inter-Quartile Range)
Unit of Measure: events per week
1.2
(0.4 to 2.6)
2.7
(1.1 to 4.6)
39.Other Pre-specified Outcome
Title BG-measured Hypoglycemic Events (One BG Record <54 mg/dL)
Hide Description BG-measured hypoglycemic events (one BG record <54 mg/dL)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Overall Number of Units Analyzed
Type of Units Analyzed: Days
20571 10285
Measure Type: Number
Unit of Measure: days
129 72
40.Other Pre-specified Outcome
Title BG-measured Hyperglycemic Events (One BG Record >350 mg/dL)
Hide Description BG-measured hyperglycemic events (one BG record >350 mg/dL)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Overall Number of Units Analyzed
Type of Units Analyzed: Days
20571 10285
Measure Type: Number
Unit of Measure: days
243 181
41.Other Pre-specified Outcome
Title Worsening of HbA1c From Baseline to 26 Weeks by >0.5%
Hide Description Worsening of HbA1c from baseline to 26 weeks by >0.5%
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Count of Participants
Unit of Measure: Participants
8
   7.1%
5
   8.9%
42.Other Pre-specified Outcome
Title Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)
Hide Description Other serious adverse events (SAE) and serious adverse device events (SADE)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Other Serious Adverse Events that do not include DKA or Severe Hypoglycemia
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Number
Unit of Measure: participants
Concussion 1 0
Otitis 1 0
Cardiac Bypass Surgery 1 0
43.Other Pre-specified Outcome
Title Adverse Device Effects (ADE)
Hide Description Adverse device effects (ADE)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) in Adults Sensor-Augmented Pump (SAP) in Adults
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Count of Participants
Unit of Measure: Participants
11
   9.8%
0
   0.0%
44.Other Pre-specified Outcome
Title Unanticipated Adverse Device Effects (UADE)
Hide Description Unanticipated adverse device effects (UADE)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study Device
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Number
Unit of Measure: Unanticipated Adverse Device Effects
1 0
45.Other Pre-specified Outcome
Title Number of Participants With SH Events
Hide Description For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
46.Other Pre-specified Outcome
Title SH Event Rate Per 100 Person-years
Hide Description For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Number
Unit of Measure: rate per 100 person-years
0 0
47.Other Pre-specified Outcome
Title Number of Participants With DKA Events
Hide Description For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.9%
0
   0.0%
48.Other Pre-specified Outcome
Title DKA Event Rate Per 100 Person-years
Hide Description For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Number
Unit of Measure: rate per 100 person-years
1.8 0
49.Other Pre-specified Outcome
Title Any Adverse Event Rate Per 100 Person-years
Hide Description For this outcome, the adverse event rate per 100 person-years calculated as a rate.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 112 56
Measure Type: Number
Unit of Measure: events per 100 person-yr
30.2 7.1
Time Frame From protocol entry through last study date which is approximately 26-28 weeks per participant.
Adverse Event Reporting Description Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.
 
Arm/Group Title Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)      0/56 (0.00%)    
Hide Serious Adverse Events
Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/112 (3.57%)      0/56 (0.00%)    
Cardiac disorders     
Cardiac Bypass Surgery   1/112 (0.89%)  1 0/56 (0.00%)  0
Ear and labyrinth disorders     
Otitis   1/112 (0.89%)  1 0/56 (0.00%)  0
Endocrine disorders     
Diabetic Ketoacidosis   1/112 (0.89%)  1 0/56 (0.00%)  0
Nervous system disorders     
Concussion   1/112 (0.89%)  1 0/56 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Closed Loop Control (CLC) Sensor-Augmented Pump (SAP)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/112 (10.71%)      2/56 (3.57%)    
Endocrine disorders     
Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis   12/112 (10.71%)  13 2/56 (3.57%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sue Brown, MD
Organization: University of Virginia
Phone: 434-962-0602
EMail: sab2f@virginia.edu
Layout table for additonal information
Responsible Party: Sue Brown, University of Virginia
ClinicalTrials.gov Identifier: NCT03563313    
Other Study ID Numbers: DCLP3
UC4DK108483 ( U.S. NIH Grant/Contract )
First Submitted: June 7, 2018
First Posted: June 20, 2018
Results First Submitted: March 31, 2020
Results First Posted: April 28, 2020
Last Update Posted: April 28, 2020