Trial Outcomes & Findings for Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use (NCT NCT02137512)

NCT ID: NCT02137512

Last Updated: 2018-10-29

Results Overview

Percentage of CGM Measured Glucose Values \<70 mg/dl during study Main Phase, night only (23:00 to 07:00)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2018-10-29

Participant Flow

Participant milestones

Measure	Closed-Loop Control System A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components: * DiAs - a smart-phone medical platform; * Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; * Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; * Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and * Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
2-Week Baseline Sensor-Augmented Pump STARTED	30
2-Week Baseline Sensor-Augmented Pump COMPLETED	30
2-Week Baseline Sensor-Augmented Pump NOT COMPLETED	0
2-Week Overnight-Only Closed-Loop STARTED	30
2-Week Overnight-Only Closed-Loop COMPLETED	30
2-Week Overnight-Only Closed-Loop NOT COMPLETED	0
2-Week 24/7 Closed-Loop STARTED	30
2-Week 24/7 Closed-Loop COMPLETED	30
2-Week 24/7 Closed-Loop NOT COMPLETED	0
5-Month 24/7 Closed-Loop STARTED	14
5-Month 24/7 Closed-Loop COMPLETED	14
5-Month 24/7 Closed-Loop NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use

Baseline characteristics by cohort

Measure	Closed-Loop Control System n=30 Participants A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components: * DiAs - a smart-phone medical platform; * Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; * Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; * Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and * Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
Age, Continuous	44 years n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	24 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants
Region of Enrollment United States	15 participants n=93 Participants
Region of Enrollment Italy	5 participants n=93 Participants
Region of Enrollment Israel	5 participants n=93 Participants
Region of Enrollment France	5 participants n=93 Participants
Diabetes duration	19 years n=93 Participants
Body-mass index (BMI)	25 kg/m^2 n=93 Participants
Hemoglobin A1c (HbA1c)	7.3 percent n=93 Participants
Daily total insulin dose	0.57 U/kg/day n=93 Participants
Daily basal insulin	0.27 U/kg/day n=93 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, night only (23:00 to 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <70 mg/dL - Main Phase, Night Only	3.0 percentage of CGM values Interval 1.1 to 6.3	1.1 percentage of CGM values Interval 0.2 to 1.6	0.4 percentage of CGM values Interval 0.2 to 1.7

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <70 mg/dL - Main Phase, Day and Night	4.1 percentage of CGM values Interval 2.0 to 7.8	2.6 percentage of CGM values Interval 1.6 to 3.6	1.7 percentage of CGM values Interval 1.1 to 2.7

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <70 mg/dL - Main Phase, Day Only	4.6 percentage of CGM values Interval 2.0 to 7.0	3.2 percentage of CGM values Interval 2.1 to 4.6	2.3 percentage of CGM values Interval 1.3 to 3.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time in Range 70-180 mg/dL - Main Phase, Day and Night	65 percentage of CGM values Interval 59.0 to 69.0	73 percentage of CGM values Interval 65.0 to 78.0	73 percentage of CGM values Interval 68.0 to 76.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time in Range 70-180 mg/dL - Main Phase, Night Only	61 percentage of CGM values Interval 53.0 to 73.0	75 percentage of CGM values Interval 69.0 to 80.0	72 percentage of CGM values Interval 65.0 to 80.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time in Range 70-180 mg/dL - Main Phase, Day Only	65 percentage of CGM values Interval 61.0 to 71.0	70 percentage of CGM values Interval 65.0 to 77.0	72 percentage of CGM values Interval 69.0 to 78.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Mean CGM sensor glucose during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Mean Sensor Glucose - Main Phase, Day and Night	157 mg/dL Standard Deviation 18	149 mg/dL Standard Deviation 12	153 mg/dL Standard Deviation 12

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Mean Sensor Glucose - Main Phase, Night Only	163 mg/dL Standard Deviation 23	150 mg/dL Standard Deviation 12	154 mg/dL Standard Deviation 13

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Mean Sensor Glucose - Main Phase, Day Only	154 mg/dL Standard Deviation 19	148 mg/dL Standard Deviation 15	152 mg/dL Standard Deviation 14

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

CGM Glucose Coefficient of Variation (CV) during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Glucose Coefficient of Variation - Main Phase, Day and Night	38 percentage Interval 34.0 to 41.0	35 percentage Interval 33.0 to 37.0	34 percentage Interval 31.0 to 37.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Glucose Coefficient of Variation - Main Phase, Night Only	36 percentage Interval 32.0 to 40.0	30 percentage Interval 29.0 to 34.0	32 percentage Interval 27.0 to 36.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Glucose Coefficient of Variation - Main Phase, Day Only	38 percentage Interval 34.0 to 42.0	37 percentage Interval 34.0 to 39.0	35 percentage Interval 31.0 to 37.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

CGM Glucose Standard Deviation (SD) during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Glucose Standard Deviation - Main Phase, Day and Night	61 mg/dL Interval 53.0 to 69.0	52 mg/dL Interval 48.0 to 58.0	51 mg/dL Interval 47.0 to 55.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Glucose Standard Deviation - Main Phase, Night Only	61 mg/dL Interval 50.0 to 69.0	47 mg/dL Interval 42.0 to 51.0	48 mg/dL Interval 40.0 to 58.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Glucose Standard Deviation - Main Phase, Day Only	58 mg/dL Interval 53.0 to 65.0	55 mg/dL Interval 49.0 to 60.0	53 mg/dL Interval 47.0 to 54.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >180 mg/dL - Main Phase, Day and Night	32 percentage of CGM values Interval 25.0 to 36.0	24 percentage of CGM values Interval 20.0 to 31.0	25 percentage of CGM values Interval 22.0 to 28.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, night only (23:00 to 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >180 mg/dL - Main Phase, Night Only	37 percentage of CGM values Interval 24.0 to 45.0	24 percentage of CGM values Interval 19.0 to 28.0	27 percentage of CGM values Interval 19.0 to 34.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >180 mg/dL - Main Phase, Day Only	31 percentage of CGM values Interval 23.0 to 35.0	23 percentage of CGM values Interval 19.0 to 32.0	25 percentage of CGM values Interval 21.0 to 29.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <50 mg/dL - Main Phase, Day and Night	0.8 percentage of CGM values Interval 0.1 to 1.3	0.2 percentage of CGM values Interval 0.1 to 0.5	0.2 percentage of CGM values Interval 0.0 to 0.4

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, night only (23:00 to 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <50 mg/dL - Main Phase, Night Only	0.3 percentage of CGM values Interval 0.0 to 1.0	0.0 percentage of CGM values Interval 0.0 to 0.1	0.0 percentage of CGM values Interval 0.0 to 0.1

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <50 mg/dL - Main Phase, Day Only	0.9 percentage of CGM values Interval 0.1 to 1.2	0.2 percentage of CGM values Interval 0.1 to 0.7	0.2 percentage of CGM values Interval 0.0 to 0.4

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <60 mg/dL - Main Phase, Day and Night	2.2 percentage of CGM values Interval 0.7 to 3.5	1.1 percentage of CGM values Interval 0.5 to 1.5	0.7 percentage of CGM values Interval 0.3 to 1.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, night only (23:00 - 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <60 mg/dL - Main Phase, Night Only	1.4 percentage of CGM values Interval 0.4 to 2.9	0.2 percentage of CGM values Interval 0.0 to 0.6	0.1 percentage of CGM values Interval 0.0 to 0.6

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <60 mg/dL - Main Phase, Day Only	2.4 percentage of CGM values Interval 0.8 to 3.5	1.4 percentage of CGM values Interval 0.7 to 1.9	0.7 percentage of CGM values Interval 0.4 to 1.1

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
LBGI - Main Phase, Day and Night	1.1 index scores Interval 0.6 to 1.9	0.8 index scores Interval 0.6 to 0.9	0.6 index scores Interval 0.4 to 0.8

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
LBGI - Main Phase, Night Only	0.7 index scores Interval 0.4 to 1.6	0.4 index scores Interval 0.3 to 0.5	0.3 index scores Interval 0.2 to 0.6

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
LBGI - Main Phase, Day Only	1.2 index scores Interval 0.8 to 1.7	0.9 index scores Interval 0.7 to 1.2	0.7 index scores Interval 0.4 to 0.9

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
AOC 70 mg/dL - Main Phase, Day and Night	0.5 mg/dL Interval 0.2 to 0.9	0.3 mg/dL Interval 0.1 to 0.4	0.2 mg/dL Interval 0.1 to 0.3

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
AOC 70 mg/dL - Main Phase, Night Only	0.3 mg/dL Interval 0.1 to 0.6	0.1 mg/dL Interval 0.0 to 0.2	0.0 mg/dL Interval 0.0 to 0.2

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
AOC 70 mg/dL - Main Phase, Day Only	0.6 mg/dL Interval 0.2 to 0.9	0.3 mg/dL Interval 0.2 to 0.5	0.2 mg/dL Interval 0.1 to 0.3

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
HBGI - Main Phase, Day and Night	6.8 index scores Interval 5.9 to 7.8	5.0 index scores Interval 4.3 to 6.2	5.5 index scores Interval 4.6 to 6.7

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
HBGI - Main Phase, Night Only	7.5 index scores Interval 5.4 to 9.7	5.1 index scores Interval 4.1 to 5.7	5.4 index scores Interval 4.3 to 6.7

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
HBGI - Main Phase, Day Only	6.4 index scores Interval 5.2 to 8.0	5.1 index scores Interval 4.4 to 7.1	5.5 index scores Interval 4.7 to 6.3

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
ADRR - Main Phase, Day and Night	27 range scores Interval 25.0 to 34.0	24 range scores Interval 21.0 to 28.0	24 range scores Interval 19.0 to 27.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
AUC 180 mg/dL - Main Phase, Day and Night	15.0 mg/dL Interval 11.7 to 18.4	9.2 mg/dL Interval 7.7 to 13.4	11.3 mg/dL Interval 7.6 to 14.2

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
AUC 180 mg/dL - Main Phase, Night Only	17.7 mg/dL Interval 7.9 to 26.4	8.4 mg/dL Interval 5.7 to 11.0	9.1 mg/dL Interval 6.4 to 14.2

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
AUC 180 mg/dL - Main Phase, Day Only	13.6 mg/dL Interval 9.6 to 17.9	10.0 mg/dL Interval 7.7 to 15.3	9.8 mg/dL Interval 7.5 to 14.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >250 mg/dL - Main Phase, Day and Night	7 percentage of CGM values Interval 4.0 to 11.0	4 percentage of CGM values Interval 3.0 to 7.0	5 percentage of CGM values Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, night only (23:00 to 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >250 mg/dL - Main Phase, Night Only	8 percentage of CGM values Interval 3.0 to 14.0	3 percentage of CGM values Interval 2.0 to 6.0	4 percentage of CGM values Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >250 mg/dL - Main Phase, Day Only	6 percentage of CGM values Interval 3.0 to 10.0	5 percentage of CGM values Interval 3.0 to 6.0	5 percentage of CGM values Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >300 mg/dL - Main Phase, Day and Night	2 percentage of CGM values Interval 1.0 to 3.0	1 percentage of CGM values Interval 0.0 to 2.0	1 percentage of CGM values Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, night only (23:00 to 07:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >300 mg/dL - Main Phase, Night Only	2 percentage of CGM values Interval 0.0 to 6.0	0 percentage of CGM values Interval 0.0 to 1.0	0 percentage of CGM values Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 2 weeks

Population: One participant was excluded due to missing baseline CGM data

Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, day only (07:00 - 23:00)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=29 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=29 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop n=29 Participants 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >300 mg/dL - Main Phase, Day Only	2 percentage of CGM values Interval 0.0 to 3.0	1 percentage of CGM values Interval 1.0 to 2.0	1 percentage of CGM values Interval 0.0 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: One subject had missing CGM data at baseline and was not included in this analysis

Mean CGM sensor glucose during Extension Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=13 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=13 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Mean Sensor Glucose - Extension Phase	8.6 mmol/L Standard Deviation 1.1	8.3 mmol/L Standard Deviation 0.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 months

Population: One participant was excluded due to missing baseline CGM data

Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=13 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=13 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Change in HbA1c - Extension Phase	7.2 percentage Standard Deviation 0.6	7.0 percentage Standard Deviation 0.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: One subject had missing CGM data at baseline and was not included in this analysis

Percentage of CGM Measured Glucose Values <3.9 mmol/L (70 mg/dL) during study Extension Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=13 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=13 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase	4.1 mmol/L Interval 2.9 to 7.5	1.3 mmol/L Interval 0.6 to 1.7	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: One subject had missing CGM data at baseline and was not included in this analysis

Percentage of CGM Measured Glucose Values <3.3 mmol/L (60 mg/dL) during study Extension Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=13 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=13 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase	2.2 mmol/L Interval 1.5 to 3.4	0.3 mmol/L Interval 0.2 to 0.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: One subject had missing CGM data at baseline and was not included in this analysis

Percentage of CGM Measured Glucose Values <2.8 mmol/L (50 mg/dL) during study Extension Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=13 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=13 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase	1.0 mmol/L Interval 0.8 to 1.3	0.1 mmol/L Interval 0.0 to 0.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: One subject had missing CGM data at baseline and was not included in this analysis

Percentage of CGM Measured Glucose Values in range 3.9-10.0 mmol/L (70-180 mg/dL)

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=13 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=13 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase	66 percentage of CGM values in range Interval 59.0 to 69.0	77 percentage of CGM values in range Interval 73.0 to 81.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: One subject had missing CGM data at baseline and was not included in this analysis

Percentage of CGM Measured Glucose Values >10.0 mmol/L (180 mg/dL) during study Extension Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=13 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=13 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase	31 percentage of CGM values >10.0 mmol/L Interval 23.0 to 38.0	22 percentage of CGM values >10.0 mmol/L Interval 19.0 to 27.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: One subject had missing CGM data at baseline and was not included in this analysis

Percentage of CGM Measured Glucose Values >13.9 mmol/L (250 mg/dL) during study Extension Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=13 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=13 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase	6 percentage of CGM values in range Interval 3.0 to 11.0	3 percentage of CGM values in range Interval 2.0 to 6.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: One subject had missing CGM data at baseline and was not included in this analysis

Percentage of CGM Measured Glucose Values >16.7 mmol/L (300 mg/dL) during study Extension Phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=13 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop n=13 Participants Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase	2 percentage of CGM values in range Interval 0.0 to 3.0	0 percentage of CGM values in range Interval 0.0 to 1.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 months

Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=14 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Episodes of Severe Hypoglycemia Events - Extension Phase	0 events	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 months

Episodes of DKA events that occurred during the 5-month extension phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=14 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Episodes of Diabetic Ketoacidosis (DKA) Events - Extension Phase	0 events	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 months

Reported serious adverse events during the 5-month extension phase

Outcome measures

Measure	2-Week Baseline Sensor-Augmented Pump n=14 Participants Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period	2-Week Overnight-Only Closed-Loop Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period	2-Week 24/7 Closed-Loop 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
Reported Serious Adverse Events - Extension Phase	0 events	—	—

Adverse Events

Closed-Loop Control System

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Closed-Loop Control System n=30 participants at risk A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components: * DiAs - a smart-phone medical platform; * Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; * Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; * Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and * Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
Renal and urinary disorders Urinary tract infection	3.3% 1/30 • Number of events 2 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Reproductive system and breast disorders Endometriosis	3.3% 1/30 • Number of events 1 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Respiratory, thoracic and mediastinal disorders Sinus Infection	3.3% 1/30 • Number of events 1 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
General disorders Cold	6.7% 2/30 • Number of events 2 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Musculoskeletal and connective tissue disorders Shoulder Pain	3.3% 1/30 • Number of events 1 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	6.7% 2/30 • Number of events 2 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Endocrine disorders Ketosis	3.3% 1/30 • Number of events 2 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Respiratory, thoracic and mediastinal disorders Sore Throat	3.3% 1/30 • Number of events 1 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Infections and infestations Tooth Infection	3.3% 1/30 • Number of events 1 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.3% 1/30 • Number of events 1 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Injury, poisoning and procedural complications Skin injury	3.3% 1/30 • Number of events 1 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Endocrine disorders Hyperglycemia	3.3% 1/30 • Number of events 1 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
Gastrointestinal disorders Nausea	3.3% 1/30 • Number of events 1 • 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.

Additional Information

John Lum, Artificial Pancreas Project Director

Jaeb Center for Health Research

Phone: 8139758690

Email: jlum@jaeb.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place