Skip to main content
Top
Published in: Diabetes Therapy 2/2019

Open Access 01-04-2019 | Insulins | Original Research

Diagnostic Accuracy of Glycated Haemoglobin and Average Glucose Values in Type 2 Diabetes Mellitus Treated with Premixed Insulin

Authors: Magdalena Walicka, Jacek Jozwiak, Jacek Rzeszotarski, Anna Zonenberg, Malgorzata Masierek, Pawel Bijos, Edward Franek

Published in: Diabetes Therapy | Issue 2/2019

Login to get access

Abstract

Introduction

Studies assessing the relationship between glycated haemoglobin (HbA1c) and average blood glucose (ABG) were conducted in small groups of patients on different treatments and may be biased for these reasons. The aim of the study was to assess the relationship between HbA1c and ABG in a large group of type 2 diabetes patients treated with premix insulin.

Methods

In 4257 patients treated with premixed insulin, the parallel point-of-care assessment of HbA1c and ABG from the preceding 90 days (ABG90), calculated automatically from all values measured by the glucometer, was performed twice. The regression formulas and respective values of HbA1c and ABG90 were calculated.

Results

The mean number of recorded glucose values/patient was 2.37 estimations per day. The regression formula calculated using data from the first assessment was HbA1c = 5.28 + 0.01487 × ABG90 and that using data from the second one was HbA1c = 4.78 + 0.01683 × ABG90. The slopes of the regression lines are lower than that in a similar analysis from the A1c-Derived Average Glucose (ADAG) study. The comparison of ADAG formula and the formula derived from the present study shows that both formulas give similar results at low HbA1c values, but differ at higher HbA1c values. Additionally, the 95% confidence interval is broader in the PROGENS study e.g. a 95% probability of certainty that the actual HbA1c value was greater than 7.0% (53 mmol/mol) was achieved only at an ABG90 value of 220 mg/dL.

Conclusion

The relationship between HbA1c and ABG estimations may be different in various patients; therefore, it seems that the use of one equation in all populations may not be reliable. Broad assessment of ABG as a tool that may replace HbA1c measurements should be recommended only with caution, providing the possible limitations and confidence intervals.

Funding

Bioton S.A.
Literature
1.
go back to reference The International Expert Committee. International Expert Committee report on the role of the A1c assay in the diagnosis of diabetes. Diabetes Care. 2009;32:1327–34.PubMedCentralCrossRef The International Expert Committee. International Expert Committee report on the role of the A1c assay in the diagnosis of diabetes. Diabetes Care. 2009;32:1327–34.PubMedCentralCrossRef
2.
go back to reference World Health Organization Consultation. Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus. Diabetes Res Clin Pract. 2011;93:299–309. World Health Organization Consultation. Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus. Diabetes Res Clin Pract. 2011;93:299–309.
3.
go back to reference American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2017;40(Suppl1):S11–24.CrossRef American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2017;40(Suppl1):S11–24.CrossRef
4.
go back to reference Lippi G, Targher G. Glycated hemoglobin (HbA1c): old dogmas, a new perspective? Clin Chem Lab Med. 2010;48:609–14.PubMed Lippi G, Targher G. Glycated hemoglobin (HbA1c): old dogmas, a new perspective? Clin Chem Lab Med. 2010;48:609–14.PubMed
5.
go back to reference Sacks DB, Arnold M, Bakris GL, et al. National Academy of Clinical Biochemistry. Position statement executive summary: Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Diabetes Care. 2011;34:1419–23. Sacks DB, Arnold M, Bakris GL, et al. National Academy of Clinical Biochemistry. Position statement executive summary: Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Diabetes Care. 2011;34:1419–23.
6.
go back to reference Sacks DB. Measurement of HbA1c. A new twist on the patch to harmony. Diabetes Care. 2012;35:2674–80. Sacks DB. Measurement of HbA1c. A new twist on the patch to harmony. Diabetes Care. 2012;35:2674–80.
7.
go back to reference Shepard JG, Airee A, Dake AW, McFarland MS, Vora A. Limitations of A1c interpretation. South Med J. 2015;108:724–9.PubMedCrossRef Shepard JG, Airee A, Dake AW, McFarland MS, Vora A. Limitations of A1c interpretation. South Med J. 2015;108:724–9.PubMedCrossRef
8.
go back to reference Liao Y, Bang D, Cosgrove S, et al. Surveillance of health status in minority communities: Racial and Ethnic Approaches to Community Health Across the US (REACH U.S.) Risk Factor Survey, US 2009. MMWR Surveill Summ. 2011;60:1–44. Liao Y, Bang D, Cosgrove S, et al. Surveillance of health status in minority communities: Racial and Ethnic Approaches to Community Health Across the US (REACH U.S.) Risk Factor Survey, US 2009. MMWR Surveill Summ. 2011;60:1–44.
9.
go back to reference Nathan DM, Kuenen J, Borg R, Zheng H, Schoenfeld D, Heine RJ. A1c-Derived Average Glucose Study Group. Translating the A1c assay into estimated average glucose values. Diabetes Care. 2008;31:1473–1478. Nathan DM, Kuenen J, Borg R, Zheng H, Schoenfeld D, Heine RJ. A1c-Derived Average Glucose Study Group. Translating the A1c assay into estimated average glucose values. Diabetes Care. 2008;31:1473–1478.
10.
11.
go back to reference American Diabetes Association. Glycemic targets. Diabetes Care. 2017;40(Suppl 1):S48–56.CrossRef American Diabetes Association. Glycemic targets. Diabetes Care. 2017;40(Suppl 1):S48–56.CrossRef
12.
go back to reference Jansen H, Stolk RP, Nolte IM, Kema IP, Wolffenbuttel BH, Snieder H. Determinants of HbA1c in nondiabetic Dutch adults: genetic loci and clinical and lifestyle parameters, and their interactions in the lifelines cohort study. J Intern Med. 2013;273:283–93.PubMedCrossRef Jansen H, Stolk RP, Nolte IM, Kema IP, Wolffenbuttel BH, Snieder H. Determinants of HbA1c in nondiabetic Dutch adults: genetic loci and clinical and lifestyle parameters, and their interactions in the lifelines cohort study. J Intern Med. 2013;273:283–93.PubMedCrossRef
13.
go back to reference Prendergast C, Smyth O, Murray F, Cunningham SK, McKenna TJ. The relationship of blood glucose and haemoglobin A1 levels in diabetes subjects. Irish J Med Sci. 1994;163:233–5.PubMedCrossRef Prendergast C, Smyth O, Murray F, Cunningham SK, McKenna TJ. The relationship of blood glucose and haemoglobin A1 levels in diabetes subjects. Irish J Med Sci. 1994;163:233–5.PubMedCrossRef
14.
go back to reference Rohlfing CL, Wiedmeyer H-M, Little RR, England JD, Tennill A, Goldstein DE. Defining the relationship between plasma glucose and HbA1c. Analysis the glucose profiles and HbA1c in the Diabetes Control and Complications Trial. Diabetes Care. 2002;25:275–78. Rohlfing CL, Wiedmeyer H-M, Little RR, England JD, Tennill A, Goldstein DE. Defining the relationship between plasma glucose and HbA1c. Analysis the glucose profiles and HbA1c in the Diabetes Control and Complications Trial. Diabetes Care. 2002;25:275–78.
17.
go back to reference Van’t Riet E, Alssema M, Rijkelijkhuizen JM, Kostense PJ, Nijpels G, Dekker JM. Relationship between A1c and glucose levels in the general Dutch population. The New Hoorn Study. Diabetes Care. 2010;33:61–66. Van’t Riet E, Alssema M, Rijkelijkhuizen JM, Kostense PJ, Nijpels G, Dekker JM. Relationship between A1c and glucose levels in the general Dutch population. The New Hoorn Study. Diabetes Care. 2010;33:61–66.
18.
go back to reference Ketema EB, Kibret K. Correlation of fasting and postprandial plasma glucose with HbA1c in assessing glycemic control; systematic review and meta-analysis. Arch Public Health. 2015;73:43.PubMedPubMedCentralCrossRef Ketema EB, Kibret K. Correlation of fasting and postprandial plasma glucose with HbA1c in assessing glycemic control; systematic review and meta-analysis. Arch Public Health. 2015;73:43.PubMedPubMedCentralCrossRef
19.
go back to reference Monnier L, Lipinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycaemia of type 2 diabetic patients. Diabetes Care. 2003;26:881–5.PubMedCrossRef Monnier L, Lipinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycaemia of type 2 diabetic patients. Diabetes Care. 2003;26:881–5.PubMedCrossRef
20.
go back to reference Walicka M, Jóźwiak J, Rzeszotarski J, et al. PROGENS-HbA1c study: safety and effectiveness of premixed recombinant human insulin (Gensulin M30). Arch Med Sci. 2016;12(5):985–91.PubMedPubMedCentralCrossRef Walicka M, Jóźwiak J, Rzeszotarski J, et al. PROGENS-HbA1c study: safety and effectiveness of premixed recombinant human insulin (Gensulin M30). Arch Med Sci. 2016;12(5):985–91.PubMedPubMedCentralCrossRef
21.
go back to reference Guidelines on the management of diabetic patients. A position of Diabetes Poland. Clin Diabetol. 2017;6 (suppl A):A1–A79. Guidelines on the management of diabetic patients. A position of Diabetes Poland. Clin Diabetol. 2017;6 (suppl A):A1–A79.
23.
go back to reference Marley JV, Oh MS, Hadgraft N, Singleton S, Isaacs K, Atkinson D. Cross-sectional comparison of point-of-care with laboratory HbA1c in detecting diabetes in real-world remote Aboriginal settings. BMJ Open. 2015;5:e006277.PubMedPubMedCentralCrossRef Marley JV, Oh MS, Hadgraft N, Singleton S, Isaacs K, Atkinson D. Cross-sectional comparison of point-of-care with laboratory HbA1c in detecting diabetes in real-world remote Aboriginal settings. BMJ Open. 2015;5:e006277.PubMedPubMedCentralCrossRef
24.
go back to reference Gialamas A, St John A, Laurence CO, Bubner TK, PoCT Management Committee. Point-of-care testing for patients with diabetes, hyperlipidemia or coagulation disorders in the general practice setting: a systematic review. Fam Pract. 2010;27:17–24. Gialamas A, St John A, Laurence CO, Bubner TK, PoCT Management Committee. Point-of-care testing for patients with diabetes, hyperlipidemia or coagulation disorders in the general practice setting: a systematic review. Fam Pract. 2010;27:17–24.
25.
go back to reference Al-Ansary L, Farmer A, Hirst J, et al. Point-of-care testing for Hb1c in the management of diabetes: a systematic review and meta-analysis. Clin Chem. 2011;57:568–76.PubMedCrossRef Al-Ansary L, Farmer A, Hirst J, et al. Point-of-care testing for Hb1c in the management of diabetes: a systematic review and meta-analysis. Clin Chem. 2011;57:568–76.PubMedCrossRef
26.
go back to reference Lenters-Westra E, Slingerland RJ. Three of 7 hemoglobin A1c point-of-care instruments do not meet generally accepted analytical performance criteria. Clin Chem. 2014;60(8):1062–72.PubMedCrossRef Lenters-Westra E, Slingerland RJ. Three of 7 hemoglobin A1c point-of-care instruments do not meet generally accepted analytical performance criteria. Clin Chem. 2014;60(8):1062–72.PubMedCrossRef
27.
go back to reference Herman WH, Cohen RM. Racial and ethnic differences in the relationship between HbA1c and blood glucose: implications for the diagnosis of diabetes. J Endocrinol Metab. 2012;97:1067–72.CrossRef Herman WH, Cohen RM. Racial and ethnic differences in the relationship between HbA1c and blood glucose: implications for the diagnosis of diabetes. J Endocrinol Metab. 2012;97:1067–72.CrossRef
28.
go back to reference Snieder H, Sawtell PA, Ross L, Walker J, Spector TD, Leslie RD. HbA1c levels are genetically determined even in type 1 diabetes: evidence from healthy and diabetic twins. Diabetes. 2001;50:2858–63.PubMedCrossRef Snieder H, Sawtell PA, Ross L, Walker J, Spector TD, Leslie RD. HbA1c levels are genetically determined even in type 1 diabetes: evidence from healthy and diabetic twins. Diabetes. 2001;50:2858–63.PubMedCrossRef
29.
go back to reference Soranzo N. Genetic determinants of variability in glycated hemoglobin (HbA1c) in humans: review of recent progress and prospects for use in diabetes care. Curr Diab Rep. 2011;11:562–9.PubMedPubMedCentralCrossRef Soranzo N. Genetic determinants of variability in glycated hemoglobin (HbA1c) in humans: review of recent progress and prospects for use in diabetes care. Curr Diab Rep. 2011;11:562–9.PubMedPubMedCentralCrossRef
Metadata
Title
Diagnostic Accuracy of Glycated Haemoglobin and Average Glucose Values in Type 2 Diabetes Mellitus Treated with Premixed Insulin
Authors
Magdalena Walicka
Jacek Jozwiak
Jacek Rzeszotarski
Anna Zonenberg
Malgorzata Masierek
Pawel Bijos
Edward Franek
Publication date
01-04-2019
Publisher
Springer Healthcare
Published in
Diabetes Therapy / Issue 2/2019
Print ISSN: 1869-6953
Electronic ISSN: 1869-6961
DOI
https://doi.org/10.1007/s13300-019-0570-1

Other articles of this Issue 2/2019

Diabetes Therapy 2/2019 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.