Trial Outcomes & Findings for Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial (NCT NCT03195140)

NCT ID: NCT03195140

Last Updated: 2023-12-08

Results Overview

Percentage of time CGM \<70 mg/dL

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 103 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2023-12-08

Participant Flow

Participant milestones

Measure	PLGS First, Then SAP Participants were randomized to use the Predictive Low-Glucose Suspend (PLGS) system first for 3 weeks, then the switch to the sensor-augmented pump (SAP) arm for 3 weeks.	SAP First, Then PLGS Participants were randomized to use the sensor-augmented pump (SAP) system first for 3 weeks, then the switch to the Predictive Low-Glucose Suspend (PLGS) arm for 3 weeks.
Overall Study STARTED	52	51
Overall Study COMPLETED	52	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

Baseline characteristics by cohort

Measure	PLGS First, Then SAP n=52 Participants Participants were randomized to use the Predictive Low-Glucose Suspend (PLGS) system first for 3 weeks, then the switch to the sensor-augmented pump (SAP) arm for 3 weeks.	SAP First, Then PLGS n=51 Participants Participants were randomized to use the sensor-augmented pump (SAP) system first for 3 weeks, then the switch to the Predictive Low-Glucose Suspend (PLGS) arm for 3 weeks.	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	29 Participants n=93 Participants	31 Participants n=4 Participants	60 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=93 Participants	19 Participants n=4 Participants	41 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Continuous	25 years STANDARD_DEVIATION 18 • n=93 Participants	23 years STANDARD_DEVIATION 16 • n=4 Participants	24 years STANDARD_DEVIATION 17 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	32 Participants n=4 Participants	58 Participants n=27 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	19 Participants n=4 Participants	45 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=93 Participants	47 Participants n=4 Participants	96 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	44 Participants n=93 Participants	38 Participants n=4 Participants	82 Participants n=27 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	6 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment United States	52 Participants n=93 Participants	51 Participants n=4 Participants	103 Participants n=27 Participants

PRIMARY outcome

Timeframe: 3 weeks

Percentage of time CGM <70 mg/dL

Outcome measures

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Hypoglycemia < 70 mg/dL	3.6 percentage of time Interval 1.9 to 5.6	2.6 percentage of time Interval 1.4 to 4.0	3.2 percentage of time Interval 1.9 to 6.1

SECONDARY outcome

Timeframe: 3 weeks

Percentage of time CGM <60 mg/dL

Outcome measures

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Hypoglycemia <60 mg/dL	1.2 percentage of time Interval 0.6 to 2.1	0.9 percentage of time Interval 0.4 to 1.6	1.2 percentage of time Interval 0.6 to 2.7

SECONDARY outcome

Timeframe: 3 weeks

Percentage of time CGM <50 mg/dL

Outcome measures

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Hypoglycemia <50 mg/dL	0.3 percentage of time Interval 0.1 to 0.6	0.2 percentage of time Interval 0.1 to 0.5	0.3 percentage of time Interval 0.1 to 0.7

SECONDARY outcome

Timeframe: 3 weeks

Area Over Curve (AOC) <70 mg/dL

Outcome measures

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Hypoglycemia AOC <70 mg/dL	0.31 mg*hr/dL Interval 0.19 to 0.55	0.25 mg*hr/dL Interval 0.11 to 0.4	0.30 mg*hr/dL Interval 0.17 to 0.65

SECONDARY outcome

Timeframe: 3 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

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Low Blood Glucose Index (LBGI)	0.9 index score Interval 0.6 to 1.3	0.8 index score Interval 0.5 to 1.1	0.9 index score Interval 0.6 to 1.5

SECONDARY outcome

Timeframe: 3 weeks

A hypoglycemia event was defined as at least two sensor values <54 mg/dL that were ≥15 min apart with no intervening values >54 mg/dL. At least two sensor values >70 mg/dL that are ≥30 min apart with no intervening values <70 mg/dL are required to end a hypoglycemic event.

Outcome measures

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Hypoglycemic Events Per Week	1.1 events/week Interval 0.5 to 2.4	0.8 events/week Interval 0.3 to 1.9	1.1 events/week Interval 0.4 to 3.0

SECONDARY outcome

Timeframe: 3 weeks

Percentage of time CGM in range 70 to 180 mg/dL

Outcome measures

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Time in Range 70-180 mg/dL	64 percentage of time Standard Deviation 15	65 percentage of time Standard Deviation 15	63 percentage of time Standard Deviation 15

SECONDARY outcome

Timeframe: 3 weeks

Percentage of time CGM >250 mg/dL

Outcome measures

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Hyperglycemia >250 mg/dL	7 percentage of time Interval 3.0 to 15.0	8 percentage of time Interval 3.0 to 13.0	8 percentage of time Interval 3.0 to 16.0

SECONDARY outcome

Timeframe: 3 weeks

Percentage of time CGM >180 mg/dL

Outcome measures

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Hyperglycemia >180 mg/dL	32 percentage of time Standard Deviation 17	32 percentage of time Standard Deviation 15	33 percentage of time Standard Deviation 16

SECONDARY outcome

Timeframe: 3 weeks

Hyperglycemia Area Under Curve of CGM >180 mg/dL

Outcome measures

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
Area Under Curve >180 mg/dL	14.7 mg*hr/dL Interval 7.5 to 24.7	15.8 mg*hr/dL Interval 8.3 to 24.1	16.9 mg*hr/dL Interval 7.4 to 25.8

SECONDARY outcome

Timeframe: 3 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

Measure	Baseline n=102 Participants Measures at baseline	Intervention Arm n=102 Participants The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Predictive Low Glucose Suspend: Application of Predictive Low Glucose Suspend	Control Arm n=102 Participants The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump.
High Blood Glucose Index (HBGI)	6.7 index score Interval 3.9 to 9.9	6.9 index score Interval 4.4 to 9.6	7.4 index score Interval 4.2 to 10.1

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 58 other events

Deaths: 0 deaths

Control Arm

Serious events: 2 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention Arm n=103 participants at risk The intervention arm (use of PLGS feature).	Control Arm n=103 participants at risk The control arm (SAP only).
Gastrointestinal disorders Bowel Obstruction	0.00% 0/103 • 3 weeks	0.97% 1/103 • Number of events 1 • 3 weeks
Endocrine disorders Severe Hypoglycemia	0.00% 0/103 • 3 weeks	0.97% 1/103 • Number of events 1 • 3 weeks

Other adverse events

Measure	Intervention Arm n=103 participants at risk The intervention arm (use of PLGS feature).	Control Arm n=103 participants at risk The control arm (SAP only).
Endocrine disorders Ketosis	56.3% 58/103 • Number of events 99 • 3 weeks	57.3% 59/103 • Number of events 91 • 3 weeks

Additional Information

Jordan Pinsker, MD

Tandem Diabetes Care, Inc

Phone: 858-366-6900

Email: clinicalaffairs@tandemdiabetes.com

Results disclosure agreements

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