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Protocol - Fasting Plasma Glucose - Glucometer

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Protocol Name from Source:

2005-06 National Health and Nutrition Examination Survey (NHANES) Oral Glucose Tolerance Test (OGTT) Procedures Manual

Availability:

Publicly available

Description:

This protocol provides basic information for measuring blood glucose concentrations using a glucose meter or glucometer. Participants are asked to fast for at least 9 hours (generally overnight) prior to the test.

Protocol:

Exclusion Criteria:

Persons will be excluded from this component if they:

• Report that they are taking oral medications for diabetes;

• Report that they are taking insulin;

• Report that they are pregnant;

• Report that they have hemophilia;

• Report that they have received cancer chemotherapy in the last 3 weeks; and

• Report that they have not fasted at least 9 hours.

SP = Sample Person.

1. Did you eat or drink anything other than plain water after [Insert time at 9 hours prior to sample collection] last night?

[ ] Yes

[ ] No

[ ] Refused

[ ] Don’t Know

If answer is "No," then he or she has met the 9-hour fast. If answer is "Yes," "Don’t know," or "Refused," then the actual fasting time is unknown.

Confirmation Question:

2. Have you had any of the following since {insert time from 1 here}?

Coffee or tea with cream and sugar? [Include milk or non-dairy creamers.]

[ ] Yes If Yes, record time and date _____________

[ ] No

Alcohol, such as beer, wine, or liquor?

[ ] Yes If Yes, record time and date _____________

[ ] No

Gum, breath mints, lozenges, or cough drops, or other cough or cold remedies?

[ ] Yes If Yes, record time and date _____________

[ ] No

Antacids, laxatives, or anti-diarrheals?

[ ] Yes If Yes, record time and date _____________

[ ] No

Dietary Supplements such as vitamins and minerals? [Include multivitamins and single nutrient supplements.]

[ ] Yes If Yes, record time and date _____________

[ ] No

3. Are you currently pregnant?

1 [ ] Yes

2 [ ] No

3 [ ] Don’t Know

If answer is "Yes," then the SP is blocked from the Fasting Plasma Glucose test. If answer is "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

4. {Is SP/Are you} now taking insulin?

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers, "Yes," the SP is excluded from the Fasting Plasma Glucose test. If answer is "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

5. {Is SP/Are you} now taking diabetic pills to lower {{his/her}/your} blood sugar? These are sometimes called oral agents or oral hypoglycemic agents

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers "Yes," the SP is excluded from the Fasting Plasma Glucose test. If the SP answers "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

6. Do you have hemophilia? (exclusion from Phlebotomy)

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers, "Yes," the SP is excluded from the Fasting Plasma Glucose test. If the SP answers "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

7. Have you received cancer chemotherapy in the past 4 weeks or do you anticipate such therapy in the next 4 weeks? (exclusion from Phlebotomy)

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers "Yes," the SP is excluded from the Fasting Plasma Glucose test. If the SP answers "No" or "Don’t Know," the SP completes Fasting Plasma Glucose test.

Using the Glucometer

There are many types of glucose meters available that are appropriate for this protocol. Follow manufacturer’s recommendations for a finger stick (or other site), calibration, and measurement.

Reference Ranges:

Fasting plasma glucose concentration between 60-100 mg/dL

Non-fasting glucose concentration between 60-139 mg/dL

Personnel and Training Required

None

Equipment Needs

Glucose meter (glucometer)

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Infant, Toddler, Child, Adolescent, Adult, Senior, All Ages, Pregnancy

Specific Instructions:

If the 9-hour fast is not met, the Diabetes Working Group (WG) recommends that the test can still be completed as a "casual" glucose concentration (see protocol for casual glucose reference ranges for screening plus/minus Diabetes).

Note from the Diabetes WG: Rather than asking if the subject had anything to eat or drink after 11:30, the WG notes that is acceptable to record the current time and time when the subject last had anything other than plain water.

Note from the Diabetes WG: The investigator should record the reason(s) a sample person is excluded from the fasting plasma glucose test.

Note from the Diabetes WG: To aid comparability, the Diabetes WG recommends that the investigator record the make and manufacturer of glucometer used and the repeatability and coefficients of variation for the assay.

Note from the Expert Review Panel: Plasma or Serum

Collection of blood samples for the measurement of analytes requires a general determination of whether to use serum or plasma for the assay and also a determination of the type of collection tube to be obtained. For example, if plasma is to be used a determination needs to be made as to whether EDTA- or heparin-containing collection tubes are used. While comparable values are obtained for many analytes from either serum or plasma, there may be situations where differences are more pronounced, and serum- or plasma-specific norms will be needed for references. The protocol presented here uses EDTA plasma. At times, it may be possible to collect both, but other considerations, such as participant burden, may be the deciding factor. It is important to match assay type with sample type. Some automated devices may preclude the use of EDTA plasma, for example, while others may be optimized for it. Investigators should choose methods of collection that match the methods of analysis. This will best be done by communicating with the laboratory where the proposed assays will be performed. They will become an important partner with you in assuring that there is compatibility from collection to assays to interpretation and reporting of levels and results.

Research Domain Information

Release Date:

October 1, 2015

Definition

A bioassay to determine the concentration of plasma glucose after a period of fasting.

Purpose

According to the American Diabetes Association (ADA, 2014a), the Fasting Plasma Glucose assay is the preferred method to screen for prediabetes and diabetes. When compared to other methods to screen for diabetes, such as the Oral Glucose Tolerance Test (OGTT) and Glycosylated Hemoglobin (HbA1c) test, the Fasting Plasma Glucose test is cheaper, easier to implement, and lower burden to participants.

Selection Rationale

While not as accurate as the hexokinase-mediated reaction, glucose meters can be used to obtain approximate glucose concentrations. This might be performed if venipuncture is not done and is preferable to not taking the measure at all.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Person Fasting Plasma Glucose Assay Concentration Value3070691CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Fast plasma gluc glucometer proto62852-9LOINC

Process and Review

The [link[phenx.org/node/62|Expert Review Panel #1]] reviewed the measures in the Anthropometrics, Diabetes, Physical Activity and Physical Fitness, and Nutrition and Dietary Supplements domains.

Guidance from the ERP includes:

• Changed name of measure

• Added recommendations on use of serum or plasma

Back-compatible: no changes to Data Dictionary

Previous version in Toolkit archive ([link[www.phenxtoolkit.org/index.php?pageLink=browse.archive.protocols&id=140000|link]])

Source

Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS). (2005-06). National Health and Nutrition Examination Survey Questionnaire. Oral Glucose Tolerance Test (OGTT) Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

General References

American Diabetes Association (ADA). (2014a). Diagnosis and classification of diabetes mellitus. Diabetes Care, 37(Suppl. 1), S81-S90.

American Diabetes Association (ADA). (2014b). Standards of medical care in diabetes-2014. Diabetes Care, 31(Suppl. 1), S14-S80.

Frank, E. A., Shubha, M. C., & D’Souza, C. J. M. (2012). Blood glucose determination: Plasma or serum? Journal of Clinical Laboratory Analysis, 26, 317-320.

Miles, R. R., Roberts, R. F., Putnam, A. R., & Roberts, W. L. (2004). Comparison of serum and heparinized plasma samples for measurement of chemistry analytes [Letter to the Editor]. Clinical Chemistry, 50(9), 1704-1705.

Protocol ID:

140802

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX140802_Eat_Or_DrinkPX140802010000Did you eat or drink anything other than plain water after 11:30 last night?4N/A
PX140802_Last_Eat_Or_Drink_TimePX140802010100When did you last eat or drink anything other than plain?4Variable Mapping
PX140802_Last_Eat_Or_Drink_DatePX140802010200When did you last eat or drink anything other than plain?4Variable Mapping
PX140802_Coffee_TeaPX140802020100Have you had any of the following since {insert time from 1 here}? Coffee or tea with cream and sugar? [Include milk or non-dairy creamers.]4Variable Mapping
PX140802_Coffee_Tea_TimePX140802020101If Yes, record time4N/A
PX140802_Coffee_Tea_DatePX140802020102If Yes, record Date4N/A
PX140802_AlcoholPX140802020201Have you had any of the following since {insert time from 1 here}? Alcohol, such as beer, wine, or liquor?4N/A
PX140802_Alcohol_TimePX140802020202If Yes, record time4N/A
PX140802_Alcohol_DatePX140802020203If Yes, record date4N/A
PX140802_GumPX140802020301Have you had any of the following since {insert time from 1 here}? Gum, breath mints, lozenges, or cough drops, or other cough or cold remedies?4N/A
PX140802_Gum_TimePX140802020302If Yes, record time4N/A
PX140802_Gum_DatePX140802020303If Yes, record date4N/A
PX140802_AntacidsPX140802020401Have you had any of the following since {insert time from 1 here}? Antacids, laxatives, or anti-diarrheals?4N/A
PX140802_Antacids_TimePX140802020402If Yes, record time4N/A
PX140802_Antacids_DatePX140802020403If Yes, record date4N/A
PX140802_Dietary_SupplementsPX140802020501Have you had any of the following since {insert time from 1 here}? Dietary Supplements such as vitamins and minerals? [Include multivitamins and single nutrient supplements.]4N/A
PX140802_Dietary_Supplements_TimePX140802020502If Yes, record time4N/A
PX140802_Dietary_Supplements_DatePX140802020503If Yes, record date4N/A
PX140802_PregnantPX140802030000Are you currently pregnant?4Variable Mapping
PX140802_Taking_InsulinPX140802040000{Is SP/Are you} now taking insulin?4Variable Mapping
PX140802_Diabetic_PillsPX140802050000{Is SP/Are you} now taking diabetic pills to lower {his/her}/your} blood sugar? These are sometimes called oral agents or oral hypoglycemic agents4Variable Mapping
PX140802_HemophiliaPX140802060000Do you have hemophilia? (exclusion from Phlebotomy)4Variable Mapping
PX140802_ChemotherapyPX140802070000Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? (exclusion from Phlebotomy)4N/A
PX140802_Exclusion_CriteriaPX140802080000Exclusion Criteria4N/A
PX140802_Equipment_Make_ManufacturerPX140802090000Make and manufacturer of the glucometer used.4N/A
PX140802_Assay_RepeatabilityPX140802100000Repeatability of the assay4N/A
PX140802_Coefficient_Of_VariationPX140802110000Coefficient of variation for the assay4N/A
PX140802_Glucose_ConcentrationPX140802120000Glucose concentration4Variable Mapping
PX140802_Fasting_Or_Casual_Glucose_ConcentrationPX140802130000Was the participant fasting?4Variable Mapping