Trial Outcomes & Findings for Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems (NCT NCT02283411)

Results Overview

Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels \<80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had up to 136 YSI samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels \<80 mg/dL.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

156 participants

Primary outcome timeframe

14 days

Results posted on

2018-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Diabetes Mellitus, Type 1 and Type 2 Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes. Abbott Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.
Overall Study STARTED	156
Overall Study COMPLETED	125
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Diabetes Mellitus, Type 1 and Type 2 Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes. Abbott Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.
Overall Study Withdrawal by Subject	3
Overall Study Screen Failed	28

Baseline Characteristics

Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetes Mellitus, Type 1 and Type 2 n=125 Participants Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes. Abbott Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.
Age, Continuous	46.7 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Region of Enrollment United States	125 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: A total number of 14284 paired points between sensor glucose readings and YSI glucose are used as the denominator to calculate the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels \<80 mg/dL.

Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels \<80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had up to 136 YSI samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels \<80 mg/dL.

Outcome measures

Outcome measures
Measure	Diabetes Mellitus, Type 1 and Type 2 n=14284 Pairs Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal\[P\] and Professional \[Pro\] and received no treatment except for safety purposes. Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes.
The Device Performance Was Evaluated in Terms of Point Accuracy of the Abbott Sensor Based Glucose Monitoring Systems in Reference to Yellow Spring Instrument (YSI). System Personal	82.9 percentage of paired points
The Device Performance Was Evaluated in Terms of Point Accuracy of the Abbott Sensor Based Glucose Monitoring Systems in Reference to Yellow Spring Instrument (YSI). System Professional	86.4 percentage of paired points

PRIMARY outcome

Timeframe: Safety was evaluated throughout the subject's study participation.

Population: All 125 subjects who participated in the study are included in this outcome measure.

Safety of the Abbott Sensor Based Glucose Monitoring Systems, including adverse device effects and serious adverse device effects were assessed for all participants enrolled in the study.

Outcome measures

Outcome measures
Measure	Diabetes Mellitus, Type 1 and Type 2 n=125 Participants Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal\[P\] and Professional \[Pro\] and received no treatment except for safety purposes. Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes.
Safety of the Abbott Sensor Based Glucose Monitoring Systems Was Characterized by Adverse Device Effects and Serious Adverse Device Effects Experienced by Study Participants.	6 Participants

SECONDARY outcome

Timeframe: 14 days

Population: A total number of 13566 paired points between sensor glucose readings and YSI glucose are used as the denominator to calculate the absolute difference between the rates of change corresponding to Sensor Reading (GM) and YSI results.

Trend accuracy of the device performance was assessed by comparing of the glucose rate of change results between the sensor glucose readings and YSI reference results for System P only.

Outcome measures

Outcome measures
Measure	Diabetes Mellitus, Type 1 and Type 2 n=13566 Pairs Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal\[P\] and Professional \[Pro\] and received no treatment except for safety purposes. Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes.
The Trend Accuracy of the System P Device Performance Was Evaluated.	82.8 Percentage of paired points

SECONDARY outcome

Timeframe: 14 days

Population: A total of 13566 paired points between sensor glucose readings and YSI glucose were used to calculate and evaluate the percentage of sensor glucose readings at different glucose rates of change and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges) in System P only.

The Continuous Glucose Error Grid Analysis (CG-EGA) in the Hypoglycemic range (YSI ≤ 70 mg/dL), in the Euglycemic range (70 \< YSI ≤ 180 mg/dL) and in the Hyperglycemic range (YSI \> 180 mg/dL) were evaluated.

Outcome measures

Outcome measures
Measure	Diabetes Mellitus, Type 1 and Type 2 n=13566 Pairs Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal\[P\] and Professional \[Pro\] and received no treatment except for safety purposes. Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes.
The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated. In the Hyperglycemic range (YSI > 180 mg/dL)	94.5 % of paired points
The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated. in the Hypoglycemic range (YSI ≤ 70 mg/dL)	86.6 % of paired points
The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated. In the Euglycemic range (70 < YSI ≤ 180 mg/dL)	97.8 % of paired points

SECONDARY outcome

Timeframe: 14 days

Population: A total number of 11444 paired points between sensor glucose readings and BG glucose are used as the denominator to calculate the percentage of sensor glucose readings that are within ±20% of the BG reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG glucose levels \<80 mg/dL.

Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the capillary blood glucose (BG) value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for capillary blood glucose (BG) levels \<80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had approximately112 capillary blood glucose (BG) samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the BG value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG levels \<80 mg/dL.

Outcome measures

Outcome measures
Measure	Diabetes Mellitus, Type 1 and Type 2 n=11444 Pairs Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal\[P\] and Professional \[Pro\] and received no treatment except for safety purposes. Abbott Sensor Based Glucose Monitoring System: Subjects wore the Abbott Sensor Based Glucose Monitoring Systems and received no treatment except for safety purposes.
The Point Accuracy of the Device Performance Was Evaluated in Reference to Capillary Blood Glucose (BG). System P	83.6 Percentage of paired points
The Point Accuracy of the Device Performance Was Evaluated in Reference to Capillary Blood Glucose (BG). System Pro	87.8 Percentage of paired points

Adverse Events

Diabetes Mellitus, Type 1 and Type 2

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diabetes Mellitus, Type 1 and Type 2 n=125 participants at risk Subjects wore the Abbott Sensor Based Glucose Monitoring Systems (Personal\[P\] and Professional \[Pro\] and received no treatment except for safety purposes. Reported adverse events were determined to be related to study procedures. Those events were observed in six (6) subjects who wore the two Systems (Personal\[P\] and Professional \[Pro\]) as required by protocol.
Skin and subcutaneous tissue disorders I. V. Blood collection related symptoms	4.8% 6/125 • Number of events 11 • up to 45 days Adverse events assessed for all participants who wore Sensors

Additional Information

Shridhara A Karinka, PhD

Abbott Diabetes Care

Phone: 510-749-6393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place