Skip to main content
Top
Published in: Systematic Reviews 1/2021

Open Access 01-12-2021 | Hypoglycemia | Research

Non-invasive and minimally invasive glucose monitoring devices: a systematic review and meta-analysis on diagnostic accuracy of hypoglycaemia detection

Authors: Nicole Lindner, Aya Kuwabara, Tim Holt

Published in: Systematic Reviews | Issue 1/2021

Login to get access

Abstract

Background

The use of minimally and non-invasive monitoring systems (including continuous glucose monitoring) has increased rapidly over recent years. Up to now, it remains unclear how accurate devices can detect hypoglycaemic episodes. In this systematic review and meta-analysis, we assessed the diagnostic accuracy of minimally and non-invasive hypoglycaemia detection in comparison to capillary or venous blood glucose in patients with type 1 or type 2 diabetes.

Methods

Clinical Trials.gov, Cochrane Library, Embase, PubMed, ProQuest, Scopus and Web of Science were systematically searched. Two authors independently screened the articles, extracted data using a standardised extraction form and assessed methodological quality using a review-tailored quality assessment tool for diagnostic accuracy studies (QUADAS-2). The diagnostic accuracy of hypoglycaemia detection was analysed via meta-analysis using a bivariate random effects model and meta-regression with regard to pre-specified covariates.

Results

We identified 3416 nonduplicate articles. Finally, 15 studies with a total of 733 patients were included. Different thresholds for hypoglycaemia detection ranging from 40 to 100 mg/dl were used. Pooled analysis revealed a mean sensitivity of 69.3% [95% CI: 56.8 to 79.4] and a mean specificity of 93.3% [95% CI: 88.2 to 96.3]. Meta-regression analyses showed a better hypoglycaemia detection in studies indicating a higher overall accuracy, whereas year of publication did not significantly influence diagnostic accuracy. An additional analysis shows the absence of evidence for a better performance of the most recent generation of devices.

Conclusion

Overall, the present data suggest that minimally and non-invasive monitoring systems are not sufficiently accurate for detecting hypoglycaemia in routine use.

Systematic review registration

PROSPERO 2018 CRD42018104812
Appendix
Available only for authorised users
Literature
1.
go back to reference BM F. The incidence and impact of hypoglycemia in type 1 and type 2 diabetes. Int Diab Monit. 2009;21:210–8. BM F. The incidence and impact of hypoglycemia in type 1 and type 2 diabetes. Int Diab Monit. 2009;21:210–8.
3.
go back to reference Lee AK, Juraschek SP, Windham BG, et al. Severe hypoglycemia and risk of falls in type 2 diabetes: the Atherosclerosis Risk in Communities (ARIC) study. Diab Care. Jul 1 2020. Lee AK, Juraschek SP, Windham BG, et al. Severe hypoglycemia and risk of falls in type 2 diabetes: the Atherosclerosis Risk in Communities (ARIC) study. Diab Care. Jul 1 2020.
5.
go back to reference Johnson-Rabbett B, Seaquist ER. Hypoglycemia in diabetes: the dark side of diabetes treatment. A patient-centered review. J Diab. Apr 15 2019. Johnson-Rabbett B, Seaquist ER. Hypoglycemia in diabetes: the dark side of diabetes treatment. A patient-centered review. J Diab. Apr 15 2019.
6.
go back to reference NICE-guideline. Type 1 diabetes in adults: diagnosis and managment. 2015. NICE-guideline. Type 1 diabetes in adults: diagnosis and managment. 2015.
10.
go back to reference Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. Oct 18 2011;155(8):529-536. Whiting PF, Rutjes AW, Westwood ME, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. Oct 18 2011;155(8):529-536.
11.
go back to reference The Nordic Cochrane Centre, The Cochrane Collaboration [computer program]. Version Version 5.3. Copenhage; 2014. The Nordic Cochrane Centre, The Cochrane Collaboration [computer program]. Version Version 5.3. Copenhage; 2014.
13.
go back to reference Doebler P. mada: meta-analysis of diagnostic accuracy. 2017. Doebler P. mada: meta-analysis of diagnostic accuracy. 2017.
14.
go back to reference R: a language and environment for statistical computing [computer program]. Version. Vienna; 2008. R: a language and environment for statistical computing [computer program]. Version. Vienna; 2008.
15.
go back to reference metaplot [computer program]. Version 0.4; 2019. metaplot [computer program]. Version 0.4; 2019.
16.
go back to reference Macaskill P GC, Deeks JJ, Harbord RM. Chapter 10: analysing and presenting results. The Cochrane Collaboration. Cochrane handbook for systematic reviews of diagnostic test accuracy version 1.0.0. 2010. Macaskill P GC, Deeks JJ, Harbord RM. Chapter 10: analysing and presenting results. The Cochrane Collaboration. Cochrane handbook for systematic reviews of diagnostic test accuracy version 1.0.0. 2010.
18.
go back to reference van Enst WA, Ochodo E, Scholten RJ, Hooft L, Leeflang MM. Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study. BMC Med Res Methodol. 2014;14:70.CrossRef van Enst WA, Ochodo E, Scholten RJ, Hooft L, Leeflang MM. Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study. BMC Med Res Methodol. 2014;14:70.CrossRef
23.
go back to reference Nakamura K, Balo A. The accuracy and efficacy of the Dexcom G4 platinum continuous glucose monitoring system. J Diabetes Sci Technol. Mar 23 2015;9(5):1021-1026. Nakamura K, Balo A. The accuracy and efficacy of the Dexcom G4 platinum continuous glucose monitoring system. J Diabetes Sci Technol. Mar 23 2015;9(5):1021-1026.
24.
30.
go back to reference Rabiee A, Andreasik V, Abu-Hamdah R, et al. Numerical and clinical accuracy of a continuous glucose monitoring system during intravenous insulin therapy in the surgical and burn intensive care units. J Diabetes Sci Technol. Jul 1 2009;3(4):951-959. Rabiee A, Andreasik V, Abu-Hamdah R, et al. Numerical and clinical accuracy of a continuous glucose monitoring system during intravenous insulin therapy in the surgical and burn intensive care units. J Diabetes Sci Technol. Jul 1 2009;3(4):951-959.
33.
go back to reference Guillot FH, Jacobs PG, Wilson LM, et al. Accuracy of the Dexcom G6 glucose sensor during aerobic, resistance, and interval exercise in adults with type 1 diabetes. Biosensors (Basel). Sep 29 2020;10(10). Guillot FH, Jacobs PG, Wilson LM, et al. Accuracy of the Dexcom G6 glucose sensor during aerobic, resistance, and interval exercise in adults with type 1 diabetes. Biosensors (Basel). Sep 29 2020;10(10).
36.
go back to reference Sadhu AR, Serrano IA, Xu J, et al. Continuous glucose monitoring in critically ill patients with COVID-19: results of an emergent pilot study. J Diabetes Sci Technol. Oct 16 2020:1932296820964264. Sadhu AR, Serrano IA, Xu J, et al. Continuous glucose monitoring in critically ill patients with COVID-19: results of an emergent pilot study. J Diabetes Sci Technol. Oct 16 2020:1932296820964264.
38.
go back to reference Alva S, Bailey T, Brazg R, et al. Accuracy of a 14-day factory-calibrated continuous glucose monitoring system with advanced algorithm in pediatric and adult population with diabetes. J Diabetes Sci Technol. Sep 19 2020:1932296820958754. Alva S, Bailey T, Brazg R, et al. Accuracy of a 14-day factory-calibrated continuous glucose monitoring system with advanced algorithm in pediatric and adult population with diabetes. J Diabetes Sci Technol. Sep 19 2020:1932296820958754.
39.
go back to reference Szadkowska A, Michalak A, Losiewicz A, et al. Impact of factory-calibrated Freestyle Libre System with new glucose algorithm measurement accuracy and clinical performance in children with type 1 diabetes during summer camp. Pediatr Diabetes. Oct 9 2020. Szadkowska A, Michalak A, Losiewicz A, et al. Impact of factory-calibrated Freestyle Libre System with new glucose algorithm measurement accuracy and clinical performance in children with type 1 diabetes during summer camp. Pediatr Diabetes. Oct 9 2020.
40.
go back to reference Castorino K, Polsky S, O'Malley G, et al. Performance of the Dexcom G6 continuous glucose monitoring system in pregnant women with diabetes. Diabetes Technol Ther. Apr 23 2020. Castorino K, Polsky S, O'Malley G, et al. Performance of the Dexcom G6 continuous glucose monitoring system in pregnant women with diabetes. Diabetes Technol Ther. Apr 23 2020.
43.
go back to reference Fokkert M, van Dijk PR, Edens MA, et al. Performance of the Eversense versus the Free Style Libre Flash glucose monitor during exercise and normal daily activities in subjects with type 1 diabetes mellitus. BMJ Open Diabetes Res Care. 2020;8(1). Fokkert M, van Dijk PR, Edens MA, et al. Performance of the Eversense versus the Free Style Libre Flash glucose monitor during exercise and normal daily activities in subjects with type 1 diabetes mellitus. BMJ Open Diabetes Res Care. 2020;8(1).
44.
go back to reference Avari P, Reddy M, Oliver N. Is it possible to constantly and accurately monitor blood sugar levels, in people with type 1 diabetes, with a discrete device (non-invasive or invasive)? Diabet Med. Feb 25 2019. Avari P, Reddy M, Oliver N. Is it possible to constantly and accurately monitor blood sugar levels, in people with type 1 diabetes, with a discrete device (non-invasive or invasive)? Diabet Med. Feb 25 2019.
45.
go back to reference Howsmon D, Bequette BW. Hypo- and hyperglycemic alarms: devices and algorithms. J Diabetes Sci Technol. Apr 30 2015;9(5):1126-1137. Howsmon D, Bequette BW. Hypo- and hyperglycemic alarms: devices and algorithms. J Diabetes Sci Technol. Apr 30 2015;9(5):1126-1137.
46.
go back to reference NICE. FreeStyle Libre for glucose monitoring. 2017. NICE. FreeStyle Libre for glucose monitoring. 2017.
47.
go back to reference Ida S, Kaneko R, Murata K. Utility of real-time and retrospective continuous glucose monitoring in patients with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials. J Diabetes Res. 2019;2019:4684815.PubMedPubMedCentral Ida S, Kaneko R, Murata K. Utility of real-time and retrospective continuous glucose monitoring in patients with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials. J Diabetes Res. 2019;2019:4684815.PubMedPubMedCentral
48.
go back to reference Koziel CBD, Morel D, Petisce J, Saliu D. Impact of continuous glucose monitors’ accuracy on their clinical utility—a quantitative assessment. Diabetes. 2018;67(Supplement 1). Koziel CBD, Morel D, Petisce J, Saliu D. Impact of continuous glucose monitors’ accuracy on their clinical utility—a quantitative assessment. Diabetes. 2018;67(Supplement 1).
49.
go back to reference Hansen EA, Klee P, Dirlewanger M, Bouthors T, Elowe-Gruau E, Stoppa-Vaucher S, et al. Accuracy, satisfaction and usability of a flash glucose monitoring system among children and adolescents with type 1 diabetes attending a summer camp. Pediatr Diabetes. 2018;19(7):1276–84. https://doi.org/10.1111/pedi.12723.CrossRefPubMed Hansen EA, Klee P, Dirlewanger M, Bouthors T, Elowe-Gruau E, Stoppa-Vaucher S, et al. Accuracy, satisfaction and usability of a flash glucose monitoring system among children and adolescents with type 1 diabetes attending a summer camp. Pediatr Diabetes. 2018;19(7):1276–84. https://​doi.​org/​10.​1111/​pedi.​12723.CrossRefPubMed
51.
go back to reference Takwoingi Y, Leeflang MM, Deeks JJ. Empirical evidence of the importance of comparative studies of diagnostic test accuracy. Ann Intern Med. Apr 2 2013;158(7):544-554. Takwoingi Y, Leeflang MM, Deeks JJ. Empirical evidence of the importance of comparative studies of diagnostic test accuracy. Ann Intern Med. Apr 2 2013;158(7):544-554.
Metadata
Title
Non-invasive and minimally invasive glucose monitoring devices: a systematic review and meta-analysis on diagnostic accuracy of hypoglycaemia detection
Authors
Nicole Lindner
Aya Kuwabara
Tim Holt
Publication date
01-12-2021
Publisher
BioMed Central
Keyword
Hypoglycemia
Published in
Systematic Reviews / Issue 1/2021
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/s13643-021-01644-2

Other articles of this Issue 1/2021

Systematic Reviews 1/2021 Go to the issue