Trial Outcomes & Findings for The International Diabetes Closed Loop (iDCL) Trial: Protocol 4 (NCT NCT04436796)

Results Overview

This results shown is mean percent time in range 70-180 mg/dL.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

13 weeks

Results posted on

2022-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Artificial Pancreas First, Then Sensor-Augmented Pump/Predicitive Low Glucose Suspend Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS. Subjects will then continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.	Sensor Augmented Pump/Predictive Low Glucose Suspend First, Then Artificial Pancreas Subjects will then continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks. Then subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
Overall Study STARTED	19	16
Overall Study COMPLETED	19	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The International Diabetes Closed Loop (iDCL) Trial: Protocol 4

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Artificial Pancreas First, Then Sensor-Augmented Pump/Predictive Low Glucose Suspend n=19 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS. After 13 weeks, participants then crossed over to the other arm.	Sensor Augmented Pump/Predictive Low Glucose Suspend First, Then Artificial Pancreas n=16 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks. After 13 weeks, participants then crossed over to the other arm.	Total n=35 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 16 • n=5 Participants	37 years STANDARD_DEVIATION 15 • n=7 Participants	39 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	16 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

This results shown is mean percent time in range 70-180 mg/dL.

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Percent CGM Time in Range 70-180 mg/dL	69 percentage of time Standard Deviation 14	66 percentage of time Standard Deviation 14

PRIMARY outcome

Timeframe: 13 weeks

Superiority for time in range 70-180 mg/dL and non-inferiority for time \<54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Non-inferiority for CGM Time <54 mg/dL	0.41 percentage of time Standard Deviation 0.39	0.71 percentage of time Standard Deviation 0.82

SECONDARY outcome

Timeframe: 13 weeks

CGM-measured mean glucose (mg/dL)

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
CGM Mean Glucose	158 mg/dL Standard Deviation 22	156 mg/dL Standard Deviation 27

SECONDARY outcome

Timeframe: 13 weeks

CGM time \> 180 mg/dL

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
CGM Time > 180	29 percentage of time Standard Deviation 15	30 percentage of time Standard Deviation 16

SECONDARY outcome

Timeframe: 13 weeks

CGM time \> 250 mg/dL

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
CGM Time > 250	9 percentage of time Standard Deviation 8	8 percentage of time Standard Deviation 8

SECONDARY outcome

Timeframe: 13 weeks

CGM time \< 70 mg/dL

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
CGM Time < 70	2.1 percentage of time Standard Deviation 1.7	3.5 percentage of time Standard Deviation 3.1

SECONDARY outcome

Timeframe: 13 weeks

CGM time \< 54 mg/dL (Superiority)

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
CGM Time < 54 (Superiority)	0.41 percentage of time Standard Deviation 0.39	0.71 percentage of time Standard Deviation 0.82

SECONDARY outcome

Timeframe: 13 weeks

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

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Coefficient of Variation	34.5 percentage SD of Mean Standard Deviation 5.3	34.9 percentage SD of Mean Standard Deviation 5.7

SECONDARY outcome

Timeframe: 13 weeks

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

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
CGM Time in Range 70-140 mg/dL	44 percentage of time Standard Deviation 14	43 percentage of time Standard Deviation 17

SECONDARY outcome

Timeframe: 13 weeks

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

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Standard Deviation	34.5 mg/dL Standard Deviation 5.3	34.9 mg/dL Standard Deviation 5.7

SECONDARY outcome

Timeframe: 13 weeks

CGM time \< 60 mg/dL

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
CGM Time < 60	0.81 percentage of time Standard Deviation 0.73	1.39 percentage of time Standard Deviation 1.45

SECONDARY outcome

Timeframe: 13 weeks

Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 \< LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 \< LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI \> 5.0 is associated with high risk of hypoglycemia.

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
LBGI	0.6 index score Standard Deviation 0.4	1.0 index score Standard Deviation 0.8

SECONDARY outcome

Timeframe: 13 weeks

CGM time \> 300 mg/dL

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
CGM Time > 300	3 percentage of time Standard Deviation 4	3 percentage of time Standard Deviation 4

SECONDARY outcome

Timeframe: 13 weeks

High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI \< 4.5 is associated with lower risk of hyperglycemia, 4.5 \< HBGI \< 9 is associated with a moderate risk of hyperglycemia and HBGI \> 9 is associated with high risk of hyperglycemia

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
HBGI	6.8 index score Standard Deviation 3.6	6.8 index score Standard Deviation 4.1

SECONDARY outcome

Timeframe: 13 weeks

Hemiglobin A1c measured after completing each study arm

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
HbA1c at 13 Weeks	6.8 percentage of glycated hemoglobin Standard Deviation 0.8	6.8 percentage of glycated hemoglobin Standard Deviation 0.9

SECONDARY outcome

Timeframe: 13 weeks

Number of participants HbA1c \<7.0% after completing each study arm

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Number of Participants With HbA1c <7.0% at 13 Weeks	19 Participants	22 Participants

SECONDARY outcome

Timeframe: 3 months

Number of participants HbA1c \<7.5% after completing each study arm

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Number of Participants With HbA1c <7.5% at 13 Weeks	26 Participants	28 Participants

SECONDARY outcome

Timeframe: 13 weeks

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

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=34 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Diabetes Distress Scale at 13 Weeks - Total Score	1.6 score on a scale Standard Deviation 0.5	1.6 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 13 weeks

The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5)

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=34 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Glucose Monitoring Satisfaction Survey (Total Scale)	3.9 score on a scale Standard Deviation 0.8	4.0 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 13 weeks

Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=34 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Hypoglycemia Confidence Scale	3.4 score on a scale Standard Deviation 0.5	3.5 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 13 weeks

Population: following study system period only

The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=34 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
INSPIRE Survey Scores - Following Study System Period Only	67.7 score on a scale Standard Deviation 23.9	—

SECONDARY outcome

Timeframe: 13 weeks

Population: following study system period

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

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=34 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
SUS Survey Scores - Following Study System Period	60.7 score on a scale Standard Deviation 25.5	—

SECONDARY outcome

Timeframe: 13 weeks

Total Daily Insulin (units)

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Total Daily Insulin	0.52 units/kg Interval 0.43 to 0.68	0.52 units/kg Interval 0.42 to 0.68

SECONDARY outcome

Timeframe: 13 weeks

Basal: bolus insulin ratio

Outcome measures

Outcome measures
Measure	Artificial Pancreas n=35 Participants Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 Participants Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Basal: Bolus Insulin Ratio	0.99 ratio Interval 0.64 to 1.94	1.13 ratio Interval 0.84 to 1.85

Adverse Events

Artificial Pancreas

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sensor Augmented Pump/Predictive Low Glucose Suspend

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Artificial Pancreas n=35 participants at risk Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 participants at risk Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Endocrine disorders Severe Hypoglycemia	0.00% 0/35 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.	2.9% 1/35 • Number of events 1 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.

Other adverse events

Other adverse events
Measure	Artificial Pancreas n=35 participants at risk Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Sensor Augmented Pump/Predictive Low Glucose Suspend n=35 participants at risk Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM \& glucometer at home for 13 weeks.
Endocrine disorders Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis	11.4% 4/35 • Number of events 4 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.	0.00% 0/35 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.
Skin and subcutaneous tissue disorders Medical Device Site Bleeding	2.9% 1/35 • Number of events 1 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.	0.00% 0/35 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.
Infections and infestations COVID-19	2.9% 1/35 • Number of events 1 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.	0.00% 0/35 • From protocol entry through last study date which is approximately 26-28 weeks per participant. Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.

Additional Information

Jordan Pinsker

Sansum Diabetes Research Institute

Phone: 805-682-7640

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place