Skip to content

CLIA-waived glucose testing for gestational diabetes

Aiding gestational diabetes diagnosis
at the point of care

Gestational diabetes (GD) is a condition in which a woman without preexisting diabetes develops high blood sugar levels during pregnancy. Like other types of diabetes, GD affects how the body processes glucose, leading to elevated blood sugar that can affect pregnancy and the baby’s health.1

ACOG guidelines recommend screening for GD between 24-28 weeks of pregnancy. 

For OB providers, the HemoCue® Glucose 201 System is the only CLIA-waived glucose testing system that delivers lab-quality accuracy at the point of care, enabling reliable diabetes diagnosis without the need for lab send-outs. 

Want to learn more about how point-of-care testing can improve efficiency and enhance treatment plans for patients with gestational diabetes? 

Contact us

Webinar: Dr. David Lubetkin on GD

Using point-of-care gestational diabetes testing can help improve patient workflows and patient satisfaction. Hear from a physician who uses this method to give his patients rapid gestational diabetes testing results.

Featured speaker: David Lubetkin, MD, FACOG  

Dr. Lubetkin is board-certified by the American Board of Obstetrics and Gynecology and a Fellow of the American College of Obstetricians and Gynecologists.

Click here to watch the webinar

What is GD?

Gestational diabetes (GD) is a growing health issue, affecting both maternal and infant health. The prevalence in the United States is steadily rising, approximately 8% to 10% of pregnant individuals develop gestational diabetes.2

Most women with gestational diabetes deliver healthy babies. However, untreated high blood sugar can lead to complications for both mother and baby.  

Certain factors can increase the risk of developing GD, including a family history of diabetes, previous gestational diabetes, obesity, and prior deliveries of babies weighing more than 4.5 kg. 

Many patients do not experience symptoms before diagnosis, making screening and early detection essential. 

Complications
of GD

For the mother1

  • High blood pressure and preeclampsia
  • C-section delivery
  • Future diabetes risk

For the baby1

  • Excessive birth weight
  • Preterm birth
  • Low blood sugar (Hypoglycemia)
  • Long-term health risks 

Testing for GD at the point of care

Our CLIA-waived glucose analyzer delivers lab-quality accuracy to aid in diabetes diagnosis

Unlike lab-send outs the HemoCue® Glucose 201 System allows healthcare providers to make care decisions in a single visit – no waiting for labs to return or scheduling a patient follow-up appointment.

Patients can have diagnostic tests performed at their physician’s office and can immediately discuss results and treatment plans. HemoCue® Glucose 201 System provides results within 1 minute.

When used effectively, POC testing can help improve clinical operations and provides a patient-friendly experience.

Contact us to learn more

Two-step strategy for
diagnosing GD

01

Non-fasting, 1-hr, 50g glucose loading test4

If results are elevated, move to step 2

02

Fasting, 3hr, 100g OGTT 

Diagnosis is made when at least two of four results are elevated.

*ACOG recommends use of venous blood. 

Two-step strategy criteria
(recommended by ACOG)

01

1-hour PG (50g GLT)4
≥ 130, 135, or 140 mg/dL 

02

FPG
≥ 95 mg/dL 

1-hour PG (100g OGTT)
≥ 180 mg/dL 

2-hour PG (100g OGTT)
≥ 155 mg/dL 

3-hour PG (100g OGTT)
≥ 140 mg/dL 

HemoCue® Glucose 201 System

The HemoCue® Glucose 201 System offers the unique possibility of testing and receiving reliable results for gestational diabetes right at the point of care. 

For point-of-care glucose testing, leave the at-home strip meters on the shelf. Get lab-quality accuracy with a fingerstick test that makes it easy to provide optimal care for patients with diabetes, and for aiding in the diagnosis of patients at risk for the disease

Go to the product page to learn more

Our service
and support

HemoCue OnCue™ Education

HemoCue OnCue™ Support is a comprehensive program designed to meet your needs as quickly and conveniently as possible. Powered by HemoCue employees, you get answers and education from the experts who know our products best.  OnCue™ Education, an integral part of HemoCue OnCue™ Support, is a series of on-demand, e-learning modules designed to ensure your team is trained on the basics of system use, specimen collection, and product maintenance.

Provide your staff access to training on HemoCue products (hematology systems, diabetes management, and more)

• Receive automatic reminders for certification renewal of operators

• Download or print completion certificates

• Certify additional users as needed

Learn more here

Our accuracy

The HemoCue® Glucose 201 System has demonstrated high accuracy when compared to other central laboratory instruments. According to the HemoCue® Glucose 201 Systems Performance Report, its performance aligns closely with both Roche and Abbott central lab analyzers.5 

 

 

Accuracy against Roche Cobas Modular

129 venous blood samples were collected and analyzed in duplicate with both methods

Each blood sample was divided in two portions: one for analysis with the HemoCue® Glucose 201 System and one for the comparative method

Note the R value on the chart (r = 0.996), this value indicates the correlation between the Glucose 201 and the Roche instrument, 0.996 is equivalent to 99.6% correlation.

Accuracy against Abbott ARCHITECT ci8200

120 venous blood samples were collected and analyzed in duplicate with HemoCue® Glucose 201 System and in single with the ARCHITECT ci8200

Note the R value on the chart (r = 0.994), this value indicates the correlation between the Glucose 201 and the Abbott instrument, 0.994 is equivalent to 99.4% correlation.

Frequently asked
questions

The The HemoCue® Glucose 201 Analyzers are factory calibrated and needs no further calibration.

You can find instructional videos for all systems at our Knowledge Center.

The reagents contained within the HemoCue® Glucose 201 Microcuvettes are moisture and temperature sensitive. The color of the reagents in dry form is faint yellow. Improper storage may give cuvettes a distinctive brown or blue-brown color and these cuvettes should not be used. As this test method relies on photometric measurement, care should be taken not to hold the cuvette by the filling end. Also take care to wipe away all contaminating substances from the outer surface of the cuvette. All unused cuvettes must remain in the original package. Use the HemoCue® Glucose 201 Microcuvettes prior to their expiry date. The expiry date is printed on each package.

Bringing HemoCue in can help: 

  • Provide immediate results and can help reduce anxiety for mom-to-be
  • Potentially increase patient adherence to lab orders
  • Can help reduce delays with patient workflow relating to: 
    • Patients not going to lab
    • Immediate scheduling of 3 hr test
    • Improved patient satisfaction
    • Reduced follow up calls

Read more about our accuracy and precision under “Our Accuracy” above, or access HemoCue OnCue™ Education here to learn more: https://hemocue.com/us/knowledge-center/#e-learning  

References

1 https://www.mayoclinic.org/diseases-conditions/gestational-diabetes/symptoms-causes/syc-20355339

2 Centers for Disease Control and Prevention (U.S.). About Gestational Diabetes (https://www.cdc.gov/diabetes/about/gestational-diabetes.html). Last updated 5/2024. Accessed 8/5/2024​

3 https://www.mayoclinic.org/diseases-conditions/gestational-diabetes/symptoms-causes/syc-20355339​

4 American Diabetes Association. Standards of Care in Diabetes 2023. Diabetes Care 2023;46 (Suppl. 1)​​ and OBG Project. Updated ACOG Guidance on Gestational Diabetes. https://www.obgproject.com/2023/01/02/acog-releases-updated-guidance-gestational-diabetes/. Accessed July 2023.​​

5 HemoCue® Glucose 201 Systems Performance Report Glucose 201

Fill out the form below and a local representative will contact you