Definitions of the levels of evidence (I—III) and grades of the recommendation (A, B, C, I) are presented at the end of the "Major Recommendations" field.
Note from the National Academy of Clinical Biochemistry (NACB) and the National Guideline Clearinghouse (NGC): The Laboratory Medicine Practice Guidelines (LMPG) evidence-based practice for point-of-care testing sponsored by the NACB have been divided into individual summaries covering disease- and test-specific areas. In addition to the current summary, the following are available:
Blood Glucose
Type 1 Diabetes Mellitus
Does blood glucose self-testing (i.e., primary care setting) lead to an improved patient (clinical) outcome in diabetes mellitus? (Literature Searches 36 and 37 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 60. There is insufficient evidence to recommend for or against routinely using self-monitoring blood glucose (SMBG). There is fair evidence that SMBG can improve health outcome. The balance between benefits and costs must be evaluated in each single environment. The consensus agreement to use SMBG in diabetes mellitus (DM) type 1 among experts is very strong (e.g., the American Diabetes Association [ADA]), and it is difficult to advise against SMBG. However greater objective evidence is still required to decide whether SMBG is really needed and which patients will benefit from it. If SMBG is going to be used, high-quality instruments should be chosen and patients must be educated in their practical use, as well as being instructed in how to use the results to monitor their insulin therapy. The evidence to support the guideline developers' view is from systematic reviews, randomized controlled trials (RCTs), as well as controlled trials without randomization, and cohort/case control studies. The evidence is, however, conflicting, and our recommendation is therefore of type I, i.e., there is insufficient evidence to recommend for or against routinely using SMBG.
Strength/consensus of recommendation: I
Level of evidence: I and II
Type 2 Diabetes Mellitus
Guideline 61. Type 2, insulin treated. The evidence to support the guideline developers' view is from systematic reviews, RCTs and controlled trials without randomization, and cohort/case control studies. The evidence is, however, conflicting and the guideline developers' recommendation is therefore of type I, i.e., there is insufficient evidence to recommend for or against routinely using SMBG. (Literature Searches 36 and 37 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Strength/consensus of recommendation: I
Level of evidence: I and II
Guideline 62. Type 2, not insulin treated. The guideline developers conclude that the evidence is insufficient to recommend for or against routinely using SMBG. The evidence to support the guideline developers' view is from systematic reviews, RCTs and controlled trials without randomization, and cohort/case control studies. The evidence is conflicting, with a lot of poor studies, although there is some evidence that SMBG is not effective in improving glycemic control or avoiding hypoglycemic attacks. Recommendation is therefore of type I, i.e., the guideline developers conclude that the evidence is insufficient to recommend for or against routinely using SMBG. If SMBG is going to be used, high-quality instruments should be chosen and patients must be educated in their practical use, as well as being instructed in how to use the results to monitor their insulin therapy. (Literature Searches 36 and 37 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Strength/consensus of recommendation: I
Level of evidence: I and II
Does blood glucose self-testing (i.e., primary care setting) lead to an economic benefit in diabetes mellitus? (Literature Searches 36 and 37 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 63. There is insufficient evidence of economical aspects to recommend for or against routinely using SMBG.
Strength/consensus of recommendation: I (there is little evidence)
Level of evidence: III
Does blood glucose point-of-care testing (POCT) in the hospital (i.e., secondary care setting) lead to an improved patient (clinical) outcome in diabetes mellitus compared with central laboratory testing? (Literature Searches 38 and 39 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 64. There is insufficient evidence to recommend for or against routinely using POC glucose testing in the hospital.
Strength/consensus of recommendation: I (there is little evidence)
Level of evidence: III
Does blood glucose POCT in the hospital (i.e., secondary care setting) lead to an economic benefit compared with central laboratory testing? (Literature Searches 38 and 39 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 65. The guideline developers recommend against routinely using POC glucose testing in the hospital setting on economic grounds.
Strength/consensus of recommendation: C
Level of evidence: II
Does blood glucose POCT (primary and secondary care) lead to an improved patient (clinical) outcome (mother and/or baby) in the case of the pregnant woman with gestational diabetes when compared with central laboratory testing? (Literature Searches 40 and 41 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 66. There is insufficient evidence to recommend for or against routinely using SMBG. The evidence to support the guideline developers' view is both from a systematic review, RCTs, as well as controlled trials without randomization, and cohort/case control studies. The evidence is, however, conflicting, and the guideline developers' recommendation is therefore of type I, i.e., there is insufficient evidence to recommend for or against routinely using SMBG. If SMBG is going to be used, high-quality instruments should be chosen and patients must be educated in their practical use, as well as being instructed in how to use the results to monitor their insulin therapy. It seems, however, rational to apply the same policy as for DM type I.
Strength/consensus of recommendation: I
Level of evidence: II
Does blood glucose POCT (primary and secondary care) lead to an economic benefit in the case of the pregnant woman with gestational diabetes when compared with central laboratory testing? (Literature Searches 40 and 41 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 67. There is insufficient evidence of economical aspects to recommend for or against routinely using SMBG in gestational diabetes mellitus. No studies have evaluated the possible economic benefit of SMBG in gestational diabetes.
Strength/consensus of recommendation: I
Level of evidence: III
Glycosylated Hemoglobin (HbA1c) Testing
Does the provision of the HbA1c result at the POC lead to an improved patient (clinical) outcome when compared with central laboratory testing? (Literature Search 42 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 68. The guideline developers conclude that there is good evidence to support the use of POCT for HbA1c in both the primary and secondary care setting. The benefit comes from the diabetes specialist having the result at the time of the patient consultation. This recommendation assumes that the POCT is implemented under proper conditions, e.g., trained and certificated operators, quality control and quality assurance, and with an analytical system comparable with that used in the central laboratory. The evidence base would benefit from studies conducted over a longer period of time.
Strength/consensus of recommendation: A
Level of evidence: I and II (2 RCTs and 2 controlled trials)
Does the provision of the HbA1c result at the POC lead to an economic benefit when compared with central laboratory testing? (Literature Search 42 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 69. The guideline developers conclude that there is some evidence to show that POCT testing for HbA1c will lead to an economic benefit. However, the data are limited, and more detailed studies are required that should focus on the wider benefit of POCT, i.e., beyond the immediate costs of providing the test and the change in clinic attendance. The evidence would benefit from studies conducted (and impacts judged) over a longer period of time.
Strength/consensus of recommendation: I
Level of evidence: II (randomized controlled trial and controlled trial, but small numbers)
Does patient self-testing for HbA1c lead to an improved patient (clinical) outcome when compared with central laboratory testing? (Literature Search 42 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 70. The guideline developers cannot make a recommendation here, because no studies have been reported.
Strength/consensus of recommendation: I
Level of evidence: III (no studies addressing the question)
What is the optimal frequency of HbA1c testing? Does more frequent testing lead to better outcomes? (Literature Search 42 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 71. There are no studies that have investigated the optimal frequency of POCT for HbA1c, and therefore the guideline developers can only recommend that the guidelines generated from studies using a laboratory service for the measurement of HbA1c be adopted in the POCT setting. There are no studies that have formally investigated the frequency of measurement of HbA1c in any setting. The guideline developers therefore recommend that HbA1c testing be performed between 2 and 4 times per year, in line with the patient's individual requirements. It is recommended that more frequent testing be required in those patients with extremely increased HbA1c levels and less frequently in those with levels approaching the reference range.
Strength/consensus of recommendation: I
Level of evidence: III (opinion of respected authorities based on clinical experience)
Fructosamine
Does the provision of the fructosamine result at the POC lead to an improved patient (clinical) outcome when compared with central laboratory testing? (Literature Search 43 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 72. Inadequate data are available to determine whether provision of fructosamine at the POC will improve glycemic control.
Strength/consensus of recommendation: I
Does the provision of the fructosamine result at the POC lead to an economic benefit when compared with central laboratory testing? (Literature Search 43 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 73. No studies have evaluated the possible economic benefit of fructosamine POCT.
Strength/consensus of recommendation: I
Does patient self-testing for fructosamine lead to an improved patient (clinical) outcome when compared with central laboratory testing? (Literature Search 43 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 74. Published evidence does not support the hypothesis that patient self-testing for fructosamine (compared to central laboratory testing) leads to improved patient outcome. There are few published studies and the data are contradictory.
Strength/consensus of recommendation: I
Level of evidence: III
What is the optimal frequency of fructosamine testing? Does more frequent testing lead to better outcomes? (Literature Search 43 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 75. No studies have addressed the optimal frequency of fructosamine POCT.
Strength/consensus of recommendation: I
Blood Ketones
Does the provision of the blood ketone result at the POC lead to an improved patient (clinical) outcome when compared with central laboratory testing? (Literature Search 44 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 76. In light of the absence of studies addressing this question, the guideline developers make no recommendation for or against routinely providing POCT for blood ketones.
Strength/consensus of recommendation: I
Level of evidence: II and III
Does the provision of the blood ketone result at the POC lead to an economic benefit when compared with central laboratory testing? (Literature Search 44 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 77. In light of the absence of studies addressing this question, the guideline developers make no recommendation for or against routinely providing POCT for blood ketones.
Strength/consensus of recommendation: I
Grade of evidence: II and III
Does patient self-testing for blood ketone lead to an improved patient (clinical) outcome when compared with central laboratory testing?
Guideline 78. In light of the absence of studies addressing this question, the guideline developers make no recommendation for or against routinely providing POCT for blood ketones.
Strength/consensus of recommendation: I
Grade of evidence: II and III
Urine Albumin
Does the provision of the urine albumin result at the POC (i.e., secondary-care setting) in the management of diabetes (e.g., early detection of diabetic nephropathy) lead to an improved patient (clinical) outcome compared with central laboratory testing? (Literature Search 45 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 79. There are no studies that have formally addressed the issue of screening for early signs of renal disease in patients with diabetes mellitus through the use of urine testing for protein or albumin at the POC. However, there is clear evidence to demonstrate an increase in urinary excretion of albumin associated with early diabetic nephropathy. Furthermore, there are several guidelines that advocate the regular checking of the urine albumin excretion in patients with diabetes mellitus.
Strength/consensus of recommendation: I
Level of evidence: III
Does the provision of the urine albumin result at the POC (i.e., secondary-care setting) in the management of diabetes (i.e., early detection of diabetic nephropathy) lead to an economic benefit when compared with central laboratory testing? (Literature Search 45 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 80. From the 1 available study, POCT for microalbuminuria with central laboratory confirmation of microalbuminuria is more expensive than testing alone, recognizing that this only takes into account the marginal cost of testing.
Strength/consensus of recommendation: I
Level of evidence: II (evidence from well-designed case-control study)
Does patient self-testing for urine albumin (i.e., primary-care setting) lead to an improved patient (clinical) outcome when compared with central laboratory testing? (Literature Search 45 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 81. In the absence of data on self-testing for microalbuminuria, there is no basis to recommend for or against this practice.
Strength/consensus of recommendation: I
What is the optimal frequency of urine albumin testing? Does more frequent testing lead to better outcomes? (Literature Search 45 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 82. In the absence of any data on the frequency of POCT for microalbuminuria, it is not possible to make any recommendation on this point, and guidance should be sought from the guideline documents that have been published on testing for microalbuminuria in diabetic patients.
Strength/consensus of recommendation: I
Level of evidence: III (opinions of respected authorities according to clinical experience)
Definitions:
Levels of Evidence
- Evidence includes consistent results from well-designed, well-conducted studies in representative populations.
- Evidence is sufficient to determine effects, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies; generalizability to routine practice; or indirect nature of the evidence.
- Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information.
Strength of Recommendations
A - The National Academy of Clinical Biochemistry (NACB) strongly recommends adoption; there is good evidence that it improves important health outcomes and concludes that benefits substantially outweigh harms.
B - The NACB recommends adoption; there is at least fair evidence that it improves important health outcomes and concludes that benefits outweigh harms.
C - The NACB recommends against adoption; there is evidence that it is ineffective or that harms outweigh benefits.
I - The NACB concludes that the evidence is insufficient to make recommendations; evidence that it is effective is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.
