Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

BACKGROUND Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence Based Laboratory Medicine Committee of the AACC jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. CONTENT In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A1c (Hb A1c) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of Hb A1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended.

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Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

Clinical Chemistry ◽

10.1373/clinchem.2011.163634 ◽

2011 ◽

Vol 57 (6) ◽

pp. 793-798 ◽

Cited By ~ 56

Author(s):

David B Sacks ◽

Mark Arnold ◽

George L Bakris ◽

David E Bruns ◽

Andrea Rita Horvath ◽

...

Keyword(s):

Diabetes Mellitus ◽

Laboratory Analysis ◽

Published Data ◽

Expert Committee ◽

Evidence Based ◽

Diagnosis And Management ◽

Hb A1c ◽

Patients With Diabetes ◽

Practice Committee

BACKGROUND Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. CONTENT In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A1c (Hb A1c) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of Hb A1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

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Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

Clinical Chemistry ◽

10.1093/clinchem/48.3.436 ◽

2002 ◽

Vol 48 (3) ◽

pp. 436-472 ◽

Cited By ~ 550

Author(s):

David B Sacks ◽

David E Bruns ◽

David E Goldstein ◽

Noel K Maclaren ◽

Jay M McDonald ◽

...

Keyword(s):

Diabetes Mellitus ◽

Scientific Evidence ◽

Glucose Monitoring ◽

Laboratory Analysis ◽

Published Data ◽

Expert Committee ◽

Clinical Value ◽

Diagnosis And Management ◽

Patients With Diabetes ◽

Practice Committee

Abstract Background: Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. Approach: An expert committee drafted evidence-based recommendations for the use of laboratory analysis in patients with diabetes. An external panel of experts reviewed a draft of the guidelines, which were modified in response to the reviewers’ suggestions. A revised draft was posted on the Internet and was presented at the AACC Annual Meeting in July, 2000. The recommendations were modified again in response to oral and written comments. The guidelines were reviewed by the Professional Practice Committee of the American Diabetes Association. Content: Measurement of plasma glucose remains the sole diagnostic criterion for diabetes. Monitoring of glycemic control is performed by the patients, who measure their own plasma or blood glucose with meters, and by laboratory analysis of glycated hemoglobin. The potential roles of noninvasive glucose monitoring, genetic testing, autoantibodies, microalbumin, proinsulin, C-peptide, and other analytes are addressed. Summary: The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are of minimal clinical value at the present time, and measurement of them is not recommended.

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Evaluation of perceived fears of COVID-19 virus infection and its relationship to health-related quality of life among patients with diabetes mellitus in Egypt during pandemic: a developing country single-center study

Diabetology International ◽

10.1007/s13340-021-00511-8 ◽

2021 ◽

Author(s):

Mohamed Abdelghani ◽

Mohamed G. Hamed ◽

Amira Said ◽

Eman Fouad

Keyword(s):

Quality Of Life ◽

Diabetes Mellitus ◽

Health Related Quality ◽

Single Center ◽

Single Center Study ◽

Patients With Diabetes ◽

Related Quality ◽

Health Related ◽

Center Study

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Do Guidelines for the Diagnosis and Monitoring of Diabetes Mellitus Fulfill the Criteria of Evidence-Based Guideline Development?

Clinical Chemistry ◽

10.1373/clinchem.2008.109082 ◽

2008 ◽

Vol 54 (11) ◽

pp. 1872-1882 ◽

Cited By ~ 17

Author(s):

Eva Nagy ◽

Joseph Watine ◽

Peter S Bunting ◽

Rita Onody ◽

Wytze P Oosterhuis ◽

...

Keyword(s):

Diabetes Mellitus ◽

Methodological Quality ◽

Guideline Development ◽

Evidence Based ◽

Test Results ◽

Time Period ◽

Therapeutic Guidelines ◽

Therapeutic Recommendations ◽

Evidence Based Guideline

Abstract Background: Although the methodological quality of therapeutic guidelines (GLs) has been criticized, little is known regarding the quality of GLs that make diagnostic recommendations. Therefore, we assessed the methodological quality of GLs providing diagnostic recommendations for managing diabetes mellitus (DM) and explored several reasons for differences in quality across these GLs. Methods: After systematic searches of published and electronic resources dated between 1999 and 2007, 26 DM GLs, published in English, were selected and scored for methodological quality using the AGREE Instrument. Subgroup analyses were performed based on the source, scope, length, origin, and date and type of publication of GLs. Using a checklist, we collected laboratory-specific items within GLs thought to be important for interpretation of test results. Results: The 26 diagnostic GLs had significant shortcomings in methodological quality according to the AGREE criteria. GLs from agencies that had clear procedures for GL development, were longer than 50 pages, or were published in electronic databases were of higher quality. Diagnostic GLs contained more preanalytical or analytical information than combined (i.e., diagnostic and therapeutic) recommendations, but the overall quality was not significantly different. The quality of GLs did not show much improvement over the time period investigated. Conclusions: The methodological shortcomings of diagnostic GLs in DM raise questions regarding the validity of recommendations in these documents that may affect their implementation in practice. Our results suggest the need for standardization of GL terminology and for higher-quality, systematically developed recommendations based on explicit guideline development and reporting standards in laboratory medicine.

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Quality of Life and Suicide Risk in Patients With Diabetes Mellitus

Psychosomatics ◽

10.1176/appi.psy.50.1.16 ◽

2009 ◽

Vol 50 (1) ◽

pp. 16-23 ◽

Cited By ~ 44

Author(s):

Maurizio Pompili ◽

David Lester ◽

Marco Innamorati ◽

Eleonora De Pisa ◽

Mario Amore ◽

...

Keyword(s):

Quality Of Life ◽

Diabetes Mellitus ◽

Suicide Risk ◽

Patients With Diabetes

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Quality of life of patients with diabetes mellitus: Social domain of health

SANAMED ◽

10.5937/sanamed1402151g ◽

2014 ◽

Vol 9 (2) ◽

pp. 151-159

Author(s):

Dragana Grujic-Vujmilovic ◽

Zivana Gavric

Keyword(s):

Quality Of Life ◽

Diabetes Mellitus ◽

Social Domain ◽

Patients With Diabetes

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Quality of care for patients with diabetes mellitus type 2 in ‘model practices’ in Slovenia – first results

Slovenian Journal of Public Health ◽

10.1515/sjph-2016-0023 ◽

2016 ◽

Vol 55 (3) ◽

pp. 179-184 ◽

Cited By ~ 2

Author(s):

Davorina Petek ◽

Mitja Mlakar

Keyword(s):

Diabetes Mellitus ◽

Quality Of Care ◽

Quality Indicators ◽

Diabetes Mellitus Type 2 ◽

Process Quality ◽

Diabetes Mellitus Type ◽

Before And After ◽

Patients With Diabetes

Abstract Background A new organisation at the primary level, called model practices, introduces a 0.5 full-time equivalent nurse practitioner as a regular member of the team. Nurse practitioners are in charge of registers of chronic patients, and implement an active approach into medical care. Selected quality indicators define the quality of management. The majority of studies confirm the effectiveness of the extended team in the quality of care, which is similar or improved when compared to care performed by the physician alone. The aim of the study is to compare the quality of management of patients with diabetes mellitus type 2 before and after the introduction of model practices. Methods A cohort retrospective study was based on medical records from three practices. Process quality indicators, such as regularity of HbA1c measurement, blood pressure measurement, foot exam, referral to eye exam, performance of yearly laboratory tests and HbA1c level before and after the introduction of model practices were compared. Results The final sample consisted of 132 patients, whose diabetes care was exclusively performed at the primary care level. The process of care has significantly improved after the delivery of model practices. The most outstanding is the increase of foot exam and HbA1c testing. We could not prove better glycaemic control (p>0.1). Nevertheless, the proposed benchmark for the suggested quality process and outcome indicators were mostly exceeded in this cohort. Conclusion The introduction of a nurse into the team improves the process quality of care. Benchmarks for quality indicators are obtainable. Better outcomes of care need further confirmation.

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INTERRELATION BETWEEN THE CHANGES IN QUALITY OF LIFE AND ARTERIAL STIFFNESS IN PATIENTS WITH DIABETES MELLITUS TYPE 2 AND CONCOMITANT OBESITY

Актуальні проблеми сучасної медицини Вісник Української медичної стоматологічної академії ◽

10.31718/2077-1096.18.4.71 ◽

2018 ◽

Vol 18 (4) ◽

pp. 71-75

Author(s):

I.M. Fushtey ◽

Ye.A. Solovyuk ◽

A.O. Solovyuk

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Diabetes Mellitus ◽

Emotional State ◽

Eating Behaviour ◽

Overweight And Obesity ◽

Healthy Individuals ◽

Patients With Diabetes

The purpose of this work was to study the general characteristics of quality of life (QoL), the effect of overweight on QoL, the nature of eating behaviour in patients with diabetes mellitus (DM) type 2 and concomitant overweight (OW) and obesity, as well as to establish the correlation with indicators of functional state of the arterial vessels. 64 people (34 women and 30 men) with DM and concomitant overweight and obesity (average age 56.3 ± 10.23 years) formed the 1 group, 34 people (19 women and 15 men), whose average age was 55.6 ± 11.92 years constituted the 2 group, and 28 healthy individuals formed the control group. SF-36v2 questionnaires were used to evaluate QoL. The effect of overweight on QoL was analyzed according to the IWQOL-Lite questionnaire data, the patterns of eating behaviour were determined by the COEQ4 for 7 days using FPRS questionnaire. The functional state of the arterial vessels was assessed by estimating the pulse wave velocity using the automated rheographic complex ReoCom (KhAI Medika (Ukraine)). The patients with DM and concomitant overweight and obesity were found to experience some changes in QoL according to the SF-36v2 questionnaire. The changes were primarily characterized by a decrease in physical activity, as well as in social and emotional status. These changes differed not only from the QoL assessment by healthy individuals, but also from those of patients with DM and normal body weight. The nature of eating behaviour in overweight or obese patients with DM was characterized by an increased hunger in parallel with a worsened emotional state and an increased desire to eat certain types of foods that can contribute to weight gain. Structural changes in arterial vessels that typically are indicative of arterial stiffness correlate with indicators of emotional state and physical activity in patients with DM and comorbid overweight and obesity.

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