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Flash glucose monitoring system in gestational diabetes: a study of accuracy and usability

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Abstract

Purpose

Studies of flash glucose monitoring systems (FGMSs) in pregnancy are insufficient, especially in gestational diabetes (GD). Our aim was to evaluate Freestyle Libre’s usability and accuracy (compared to self-monitoring of blood glucose [SMBG]) for GD patients in real-life conditions.

Methods

This is a prospective study with pregnant women diagnosed with GD (n = 24 for the usability analysis; n = 19 for the accuracy analysis). The study duration was up to 28 days (lifetime of two sensors). Participants executed a minimum of four daily FGMS readings obtained immediately after capillary SMBG. Analytical accuracy was assessed with mean absolute relative difference (MARD) and mean absolute difference (MAD); clinical accuracy was assessed with Surveillance Error Grid (SEG). Usability was evaluated with a user acceptability questionnaire.

Results

The mean pregestational BMI was 25.21 ± 5.15 kg/m2 (mean ± SD), the mean gestational age was 30.31 ± 2.02 weeks, and the mean glucose values were 76.63 ± 7.49 mg/dL. A total of 1339 SMBG–FGMS pairs of values were obtained. Analytical accuracy was good with an overall MARD of 14.07% and an in-target MARD of 13.79%. The number of SMBG–FMGS pairs for above-target values was low (122 of 1339) with an associated MARD of 17.95%. Clinical accuracy of the FGMS was demonstrated, with 94.4% of values in the no-risk or slight, lower risk zones of the SEG. FGMS accuracy was unaffected by pregestational BMI or gestational age. The user acceptability questionnaire showed high levels of satisfaction, with 95.8–100% preferring FGMS to SMBG. No unexpected or severe adverse effects occurred.

Conclusion

FGMS showed good performance in GD regarding accuracy and usability. Larger studies are needed to corroborate our results, verify the analytical accuracy of above-target values as this glucose range might lead to initiation or adjustment of pharmacological therapy, and ultimately establish definitive recommendations regarding prescription of FGMS for GD patients.

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Authors and Affiliations

  1. Department of Endocrinology, Hospital de Braga, Braga, Portugal

    Sara Campos Lopes, Mariana Barbosa, Ana Catarina Matos, Maria Lopes Pereira, Ana Margarida Monteiro & Vera Fernandes

  2. School of Medicine, University of Minho, Braga, Portugal

    Ana Isabel Brito

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  1. Sara Campos Lopes
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  2. Ana Isabel Brito
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  3. Mariana Barbosa
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Correspondence to Sara Campos Lopes.

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This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee for Health of Hospital de Braga and the Ethics Committee for Life and Health Sciences of University of Minho.

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Campos Lopes, S., Brito, A.I., Barbosa, M. et al. Flash glucose monitoring system in gestational diabetes: a study of accuracy and usability. Hormones 22, 703–713 (2023). https://doi.org/10.1007/s42000-023-00485-z

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