Measuring Blood Glucose Using Capillary Blood with Blood

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Measuring Blood Glucose Using Capillary Blood with Blood

Transcript Of Measuring Blood Glucose Using Capillary Blood with Blood

Measuring Blood Glucose Using Capillary Blood with Blood Glucose
Meters in all Hospital Settings
Meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel March 30, 2018
Leslie Landree, PhD Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health Food and Drug Administration

Evaluation of Blood Glucose Monitoring System Performance
Precision - Interferences - Accuracy

 Precise x Accurate

x Precise  Accurate

 Precise  Accurate
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Accuracy Evaluation

At Home Setting Healthy People with Diabetes

Hospital Settings

Hospitals, Emergency Departments, Operating Rooms

Ambulatory Setting Physican’s Office

Nursing homes

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Accuracy Evaluation of Blood Glucose Monitoring Systems
• In the hands of the intended user • Environment reflective of the actual use setting • Results of the system compared to a comparator method
- accurate and precise laboratory method • Evaluation of each claimed sample type (arterial, venous,
capillary, neonatal heelstick etc.)
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Summary of Accuracy Results

Within ±5%

Within ±10%

N (%)

N (%)

Within ±12%
N (%)

Within ±15%
N (%)

Within ±20%
N (%)

Exceeds ±20%
N (%)

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Summary of Accuracy Results

Blood Glucose Concentrations <75 mg/dL

Within ±5 mg/dL

Within ±10 mg/dL

Within ±12 mg/dL

Within ±15 mg/dL

N (%)

N (%)

N (%)

N (%)

Exceeds ±15 mg/dL
N (%)

Blood Glucose Concentrations ≥75 mg/dL

Within ±5%

Within ±10%

Within ±12%

Within ±15%

N (%)

N (%)

N (%)

N (%)

Within ±20%
N (%)

Exceeds ±20%
N (%)

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StatStrip Glucose Hospital Meter System
• FDA cleared for use throughout all hospital and professional healthcare settings with: - venous whole blood - arterial whole blood, - neonatal arterial and heel stick sample
• Limited against use of capillary samples in patients receiving intensive medical intervention/therapy
• Study included samples obtained from 1698 patients at 5 different hospitals
• Settings included emergency rooms, operating rooms, oncology departments, intensive care units, medical intensive care units, surgical intensive care units, cardiovascular surgical intensive care units, pediatric intensive care units, transplant departments, cardiac departments, nursing, and surgical departments 7

StatStrip Glucose Hospital Meter System

with Arterial and Venous Samples

Glucose <75 mg/dL

Specimen Type

Within

Within

Within

Within

Exceed

±5 mg/dL ±10 mg/dL ±12 mg/dL ±15 mg/dL ±15 mg/dL

Arterial Venous

163/201 (81.1%) 68/79 (86.1%)

189/201 (94.0%) 77/79 (97.5%)

195/201 (97.0%) 78/79 (98.7%)

197/201 (98.0%) 79/79 (100%)

4/201 (2.0%) 0/79 (0.0%)

Glucose ≥75 mg/dL

Specimen Type

Within ±5%

Arterial

844/1267 (66.6%)

Venous

171/268 (63.8%)

Within ±10% 1175/1267 (92.7%) 246/268 (91.8%)

Within ±12% 1220/1267 (96.3%) 260/268 (97.0%)

Within ±15% 1244/1267 (98.2%) 267/268 (99.6%)

Within ±20% 1258/1267 (99.3%) 268/268 (100%)

Exceeds ±20% 9/1267 (0.7%) 0/268 (0.0%)

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StatStrip

Glucose <75 mg/dL

Specimen Type

Within ±12 mg/dL

Arterial Venous

195/201 (97.0%) 78/79 (98.7%)

Glucose ≥75 mg/dL

Specimen Type

Within ±12%

Arterial

1220/1267 (96.3%)

Venous

260/268 (97.0%)

POCT12
95% of the results within +/- 12 mg/dL for values <100 mg/dL
95% of the results within +/- 12.5% for values >100 mg/dL

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StatStrip

Glucose <75 mg/dL

Specimen Type

Within ±12 mg/dL

Arterial Venous

195/201 (97.0%) 78/79 (98.7%)

POCT12
95% within +/- 12 mg/dL < 100 mg/dL

FDA BGMS Guidance
95% within +/- 12 mg/dL < 75 mg/dL

Glucose ≥75 mg/dL

Specimen

Within

Type Arterial Venous

±12% 1220/1267
(96.3%) 260/268 (97.0%)

95% within +/- 12.5% > 100 mg/dL

95% within +/- 12.0% ≥ 75 mg/dL

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Care UnitsBloodCapillary BloodVenousBlood Glucose