Trial Outcomes & Findings for In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System (NCT NCT00803777)

Results Overview

Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values \<75mg/dL) or +/- 20% (for reference blood glucose values \>/= 75mg/dL)of the reference results were calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

147 participants

Primary outcome timeframe

1-2 hours

Results posted on

2016-02-29

Participant Flow

Subjects actually recruited ranged in age from 5 to 24 years old. Subjects under age 18 were accompanied by a parent or guardian.

Participant milestones

Participant milestones
Measure	Intended Users of the Monitoring System Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
Overall Study STARTED	147
Overall Study COMPLETED	147
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the Monitoring System n=147 Participants Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
Age, Customized 4-12 years of age	55 participants n=5 Participants
Age, Customized 13-17 years of age	54 participants n=5 Participants
Age, Customized 18-24 years of age	38 participants n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Region of Enrollment United States	147 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-2 hours

Population: Some subjects \>=13 years old consented to provide larger capillary samples for YSI glucose analysis. Subjects and HCPs provided duplicate results, but one subject's HCP provided only one glucose result. One subject sample was too small to run the YSI analysis; another subject was given carbohydrate to prevent low blood sugar (no results obtained)

Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values \<75mg/dL) or +/- 20% (for reference blood glucose values \>/= 75mg/dL)of the reference results were calculated.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=79 Participants Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method Subjects' Test Results (n=158)	142 number of capillary results (n=79x2)
Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method HCP Test Results (n=157)	143 number of capillary results (n=79x2)

PRIMARY outcome

Timeframe: 1-2 hours

Population: One subject's results were not used because the subject was given carbohydrate to prevent low blood sugar.

Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values \<75mg/dL) and within +/- 20% (for reference BG values \>= 75mg/dL)of the HCP results was calculated.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=146 Participants Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results	277 number of Subject BGM Results (n=146x2)

SECONDARY outcome

Timeframe: 1-2 hours

Population: Some subjects \>=13 yrs consented to provide larger capillary samples for YSI glucose analysis. One subject's sample was insufficient to run the YSI analysis. Another subject's results were not useable as the subject was given carbohydrate to prevent low blood sugar. Duplicate subject BG results provided 158 possible data points.

The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=79 Participants Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies Zone A	146 Number of BG results in zone (n=79x2)
Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies Zone B	11 Number of BG results in zone (n=79x2)
Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies Zone C	1 Number of BG results in zone (n=79x2)
Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies Zone D	0 Number of BG results in zone (n=79x2)
Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies Zone E	0 Number of BG results in zone (n=79x2)

SECONDARY outcome

Timeframe: 1-2 hours

Population: For 2 different subjects, study staff did not rate subject success at 1 task.

Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows: 1. Successful in performing tasks correctly without assistance 2. Successful after study staff prompted participant to review User Guide. 3. Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.) 4. Subject did not perform task correctly and study staff intervention was required.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=147 Participants Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
Number of Participants Rated as <=2 (Labeling Comprehension) Turn meter on and off (n=147)	147 participants
Number of Participants Rated as <=2 (Labeling Comprehension) Set time and date (n=147)	137 participants
Number of Participants Rated as <=2 (Labeling Comprehension) Put strip into the meter (n=146)	146 participants
Number of Participants Rated as <=2 (Labeling Comprehension) Run control solution (n=146)	144 participants
Number of Participants Rated as <=2 (Labeling Comprehension) Switch from level 1 to level 2 features (n=147)	135 participants

SECONDARY outcome

Timeframe: 1-2 hours

Population: Meter results were used from subject and HCP data that had numeric values for duplicate BG self-tests. One subject data set was not used because subject was given carbohydrate to prevent low blood sugar. Two subjects' meter results contained outliers (NCCLS EP-9A) and one HCP's results had only one replicate result so these sets were not analyzed.

The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=145 Participants Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
Average Within Replicate Coefficient of Variation CV (Precision) Average Subject (144) Coefficient of Variation CV	5.9 percentage CV
Average Within Replicate Coefficient of Variation CV (Precision) Average HCP (145) Coefficient of Variation CV	7.2 percentage CV

Adverse Events

Intended Users of the Monitoring System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carmine Greene, Senior Clinical Research Scientist

Ascensia Diabetes Care

Phone: 574-257-3040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60