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Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials

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Abstract

Aims

Self-monitoring of blood glucose (SMBG) represented a major breakthrough in the treatment of type 1 diabetes. The aim of the present meta-analysis is to assess the effect of continues glucose monitoring (CGM) and flash glucose monitoring (FGM), on glycemic control in type 1 diabetes.

Materials and methods

The present analysis includes randomized clinical trials comparing CGM or FGM with SMBG, with a duration of at least 12 weeks, identified in Medline or clinicaltrials.gov. The principal endpoint was HbA1c at the end of the trial. A secondary endpoint was severe hypoglycemia. Mean and 95% confidence intervals for HbA1c and Mantel–Haenzel odds ratio [MH-OR] for severe hypoglycemia were calculated, using random effect models. A sensitivity analysis was performed using fixed effect models. In addition, the following secondary endpoints were explored, using the same methods: time in range, health-related quality of life, and treatment satisfaction. Separate analyses were performed for trials comparing CGM with SMBG, and those comparing CGM + CSII and SMBG + MDI and CGM-regulated insulin infusion system (CRIS) and CSII + SMBG.

Results

CGM was associated with a significantly lower HbA1c at endpoint in comparison with SMBG (− 0.24 [− 0.34, − 0.13]%); CGM was associated with a significantly lower risk of severe hypoglycemia than SMBG. Treatment satisfaction and quality of life were not measured, or not reported, in the majority of studies. FGM showed a significant reduction in the incidence of mild hypoglycemia and an increased treatment satisfaction, but no significant results are shown in HbA1c. CGM + CSII in comparison with SMBG + MDI was associated with a significant reduction in HbA1c. Only two trials with a duration of at least 12 weeks compared a CRIS with SMBG + CSII; HbA1c between the two treatment arms was not statistically significant (difference in means: − 0.23 [− 0.91; 0.46]%; p = 0.52).

Conclusion

GCM compared to SMBG has showed a reduction in HbA1c and severe hypoglycemia in patient with type 1 diabetes. The comparison between CGM + CSII and SMBG + MDI showed a large reduction in HbA1c; it is conceivable that the effects of CSII + CGM on glycemic control additives. The only comparison available between FGM and SMBG was conducted in patients in good control.

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Funding

This research was performed independently of any funding, as part of the institutional activity of the investigators. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

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  1. I. Dicembrini and C. Cosentino have contributed equally to this work.

Authors and Affiliations

  1. Diabetology, Careggi Hospital, Florence, Italy

    I. Dicembrini, C. Cosentino, M. Monami, E. Mannucci & L. Pala

  2. University of Florence, Florence, Italy

    I. Dicembrini & E. Mannucci

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  1. I. Dicembrini
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  2. C. Cosentino
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Correspondence to L. Pala.

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Dicembrini, I., Cosentino, C., Monami, M. et al. Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials. Acta Diabetol 58, 401–410 (2021). https://doi.org/10.1007/s00592-020-01589-3

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