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Am J Perinatol 2023; 40(11): 1149-1157
DOI: 10.1055/a-2053-7650
SMFM Fellowship Series Article

Comparison of an Intermittently Scanned (Flash) Continuous Glucose Monitoring System to Standard Self-Monitoring of Capillary Blood Glucose in Gestational Diabetes Mellitus

Farrah N. Hussain 
1   Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Mount Sinai West, Icahn School of Medicine at Mount Sinai, New York, New York
,
Samantha Raymond
2   Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York
,
Kristina M. Feldman 
1   Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Mount Sinai West, Icahn School of Medicine at Mount Sinai, New York, New York
,
Sophia Scarpelli-Shchur
1   Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Mount Sinai West, Icahn School of Medicine at Mount Sinai, New York, New York
,
Tirtza S. Strauss
1   Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Mount Sinai West, Icahn School of Medicine at Mount Sinai, New York, New York
,
Zainab Al-Ibraheemi
1   Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Mount Sinai West, Icahn School of Medicine at Mount Sinai, New York, New York
,
Lois Brustman
1   Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Mount Sinai West, Icahn School of Medicine at Mount Sinai, New York, New York
› Author Affiliations Funding None.
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Abstract

Objective Gestational diabetes mellitus (GDM) requires close surveillance of blood glucose to prevent perinatal morbidity. Self-monitoring of capillary blood glucose (BGM) comes with considerable psychosocial burden. Intermittently scanned continuous glucose monitor (isCGM) devices are discreet and could considerably impact the lifestyle of the patient. They are designed to replace BGM testing in nonpregnant patients. Data on this technology in pregnancy are scant. The aim of this study was to assess concordance of BGM with isCGM in GDM.

Study Design Institutional review board approved prospective single-arm study evaluating agreement of isCGM (Freestyle Libre 14-day system) compared with BGM when determining glucose levels fasting and 2-hour postprandial for 14 days. This was documented as percentage of results within Zone A (clinically accurate measurements with no effect on clinical action) or Zone B (values that deviate from reference by >20% but would lead to benign/no treatment) of the Parkes Error Grid (developed for nonpregnant patients with diabetes). Per International Organization for Standardization criteria, agreement was defined as >95% within Zone A or B. Analytical agreement was evaluated using mean and median absolute relative difference (ARD), mean and median absolute difference (AD).

Results There were 1,604 pairs of BGM/isCGM observations for 41 patients. Mean glucose values were 102.0 (standard deviation [SD] = 20.5) and 89.4 (SD = 20.1) mg/dL for BGM and isCGM, respectively. Mean and median AD were 15.9 and 13.0 mg/dL, respectively. Mean and median ARD were 15.9 and 12.5%, respectively. Zones A and B contained 76.9 and 22.9% of values, respectively, in the Parkes Error Grid, for a total of 99.8%.

Conclusion BGM and isCGM demonstrate clinical agreement. However, glucose values with isCGM trended lower, with greater mean and median ARD than prior studies. Given the strict glycemic control required during pregnancy, physicians should be aware of these differences and their possible clinical implications.

Key Points

  • Gestational diabetes mellitus requires close surveillance of blood glucose.

  • isCGM is painless and discreet; however, values trend lower than capilary blood glucose.

  • Physicians should be aware of these differences and possible clinical implications.

Keywords

gestational diabetes - continuous glucose monitoring - glycemic control - freestyle libre

Note

Abstract was presented at the Society for Maternal-Fetal Medicine 42nd Annual Pregnancy Meeting, February 2022.




Publication History

Received: 14 September 2022

Accepted: 24 February 2023

Accepted Manuscript online:
14 March 2023

Article published online:
10 April 2023

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  • References

  • 1 ACOG Practice Bulletin No. ACOG Practice Bulletin No. 190: gestational diabetes mellitus. Obstet Gynecol 2018; 131 (02) e49-e64
    CrossrefPubMedGoogle Scholar
  • 2 Metzger BE, Lowe LP, Dyer AR. et al; HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med 2008; 358 (19) 1991-2002
    CrossrefPubMedGoogle Scholar
  • 3 Rosenstein MG, Cheng YW, Snowden JM, Nicholson JM, Doss AE, Caughey AB. The risk of stillbirth and infant death stratified by gestational age in women with gestational diabetes. Am J Obstet Gynecol 2012; 206 (04) 309.e1-309.e7
    CrossrefPubMedGoogle Scholar
  • 4 Cengiz E, Tamborlane WV. A tale of two compartments: interstitial versus blood glucose monitoring. Diabetes Technol Ther 2009; 11 (01) S11-S16
    CrossrefPubMedGoogle Scholar
  • 5 Koschinsky T, Jungheim K, Heinemann L. Glucose sensors and the alternate site testing-like phenomenon: relationship between rapid blood glucose changes and glucose sensor signals. Diabetes Technol Ther 2003; 5 (05) 829-842
    CrossrefPubMedGoogle Scholar
  • 6 American Diabetes Association. 7. Diabetes technology: standards of medical care in diabetes-2021. Diabetes Care 2021; 44 (Suppl. 01) S85-S99
    CrossrefPubMedGoogle Scholar
  • 7 Lane AS, Mlynarczyk MA, de Veciana M, Green LM, Baraki DI, Abuhamad AZ. Real-time continuous glucose monitoring in gestational diabetes: a randomized controlled trial. Am J Perinatol 2019; 36 (09) 891-897
    Article in Thieme ConnectPubMedGoogle Scholar
  • 8 Yu F, Lv L, Liang Z. et al. Continuous glucose monitoring effects on maternal glycemic control and pregnancy outcomes in patients with gestational diabetes mellitus: a prospective cohort study. J Clin Endocrinol Metab 2014; 99 (12) 4674-4682
    CrossrefPubMedGoogle Scholar
  • 9 Alfadhli E, Osman E, Basri T. Use of a real time continuous glucose monitoring system as an educational tool for patients with gestational diabetes. Diabetol Metab Syndr 2016; 8: 48
    CrossrefPubMedGoogle Scholar
  • 10 Feig DS, Donovan LE, Corcoy R. et al; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet 2017; 390 (10110): 2347-2359
    CrossrefPubMedGoogle Scholar
  • 11 Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Ther 2017; 8 (01) 55-73
    CrossrefPubMedGoogle Scholar
  • 12 Laboratories A. . The FreeStyle Libre 14 day system. Accessed January 10, 2023 at: https://www.freestyle.abbott/us-en/products/freestyle-14-day.html
    PubMed
  • 13 Scott EM, Bilous RW, Kautzky-Willer A. Accuracy, user acceptability, and safety evaluation for the FreeStyle Libre flash glucose monitoring system when used by pregnant women with diabetes. Diabetes Technol Ther 2018; 20 (03) 180-188
    CrossrefPubMedGoogle Scholar
  • 14 Cheng YW, Block-Kurbisch I, Caughey AB. Carpenter-Coustan criteria compared with the national diabetes data group thresholds for gestational diabetes mellitus. Obstet Gynecol 2009; 114 (2 Pt 1): 326-332
    CrossrefPubMedGoogle Scholar
  • 15 Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010; 12 (09) 679-684
    CrossrefPubMedGoogle Scholar
  • 16 Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 2000; 23 (08) 1143-1148
    CrossrefPubMedGoogle Scholar
  • 17 International Standards Organization. ISO 15197:2013. In vitro diagnostic test systems – requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. 2018 http://www.iso.org/cms/render/live/en/sites/isoorg/contents/data/standard/05/49/54976.html
    PubMedGoogle Scholar
  • 18 Danne T, Nimri R, Battelino T. et al. International consensus on use of continuous glucose monitoring. Diabetes Care 2017; 40 (12) 1631-1640
    CrossrefPubMedGoogle Scholar
  • 19 Team RC. A language and environment for statistical computing. 2020 https://www.R-project.org/
    PubMedGoogle Scholar
  • 20 Schmolze D. . ega: Error grid analysis 2017 https://CRAN.R-project.org/package=ega
    PubMed
  • 21 Jason Bryer KS. . likert: analysis and visualization Likert items 2016 https://CRAN.R-project.org/package=likert
    PubMed
  • 22 Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The performance and usability of a factory-calibrated flash glucose monitoring system. Diabetes Technol Ther 2015; 17 (11) 787-794
    CrossrefPubMedGoogle Scholar
  • 23 Nørgaard SK, Mathiesen ER, Nørgaard K, Ringholm L. Comparison of glycemic metrics measured simultaneously by intermittently scanned continuous glucose monitoring and real-time continuous glucose monitoring in pregnant women with type 1 diabetes. Diabetes Technol Ther 2021; 23 (10) 665-672
    CrossrefPubMedGoogle Scholar
  • 24 Kristensen K, Ögge LE, Sengpiel V. et al. Continuous glucose monitoring in pregnant women with type 1 diabetes: an observational cohort study of 186 pregnancies. Diabetologia 2019; 62 (07) 1143-1153
    CrossrefPubMedGoogle Scholar
  • 25 Davison JM. Edema in pregnancy. Kidney Int Suppl 1997; 59: S90-S96
    PubMedGoogle Scholar
  • 26 Marchetti D, Carrozzino D, Fraticelli F, Fulcheri M, Vitacolonna E. Quality of life in women with gestational diabetes mellitus: a systematic review. J Diabetes Res 2017; 2017: 7058082
    CrossrefPubMedGoogle Scholar
  • 27 Kopec JA, Ogonowski J, Rahman MM, Miazgowski T. Patient-reported outcomes in women with gestational diabetes: a longitudinal study. Int J Behav Med 2015; 22 (02) 206-213
    CrossrefPubMedGoogle Scholar