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Multicenter Study
. 2024 Sep;61(9):1177-1184.
doi: 10.1007/s00592-024-02298-x. Epub 2024 Jun 4.

Effectiveness of the flash glucose monitoring system in preventing severe hypoglycemic episodes and in improving glucose metrics and quality of life in subjects with type 1 diabetes at high risk of acute diabetes complications

Alessandra Dei Cas  1   2 , Raffaella Aldigeri  3 , Giulia Bellei  4 , Davide Raffaeli  4 , Paolo Di Bartolo  5 , Alessandra Sforza  6 , Giulio Marchesini  7 , Anna Vittoria Ciardullo  8 , Valeria Manicardi  9 , Maurizio Bianco  10 , Marcello Monesi  11 , Anna Vacirca  12 , Maria Cristina Cimicchi  13 , Paola Anna Sordillo  5 , Mattia Altini  14 , Federica Fantuzzi  3 , Riccardo C Bonadonna  3   15 ; Flash-glucose monitoring Emilia Romagna Regional network
Collaborators, Affiliations
Multicenter Study

Effectiveness of the flash glucose monitoring system in preventing severe hypoglycemic episodes and in improving glucose metrics and quality of life in subjects with type 1 diabetes at high risk of acute diabetes complications

Alessandra Dei Cas et al. Acta Diabetol. 2024 Sep.

Abstract

Aims: To assess the effectiveness of the intermittent-scanned continuous glucose monitoring (isCGM) system in preventing severe hypoglycemic episodes and in improving glucose parameters and quality of life.

Methods: Four hundred T1D individuals were enrolled in a prospective real-word study with an intermittently scanned continuous glucose monitoring device during the 12-months follow-up. The primary endpoint was the incidence of severe hypoglycemic events.

Results: 82% of subjects were naïve to the use of the device (group A) and 18% were already wearing the system (group B). The cumulative incidence of severe hypoglycemia (SH) at 12 months was 12.06 per 100 person-year (95% CI: 8.35-16.85) in group A and 10.14 (95% CI: 4.08-20.90) in group B without inter-group differences. In group A there was a significant decrease in SH at 12 months compared to 3 months period (p = 0.005). Time in glucose range significantly increased in both groups accompanied with a significant decrease in glucose variability. HbA1c showed a progressive significant time-dependent decrease in group A. The use of the device significantly improved the perceived quality of life.

Conclusion: This study confirmed the effectiveness of the isCGM in reducing hypoglycemic risk without glucose deterioration, with potential benefits on adverse outcomes in T1D individuals.

Trial registration: ClinicalTrials.gov registration no. NCT04060732.

Keywords: Intermittent-scanned continuous blood glucose monitoring; Severe hypoglycemia; Type 1 diabetes.

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Conflict of interest statement

ADC has received lecture fees from MSD, AstraZeneca, Eli Lilly, Sanofi, DOC generici, Servier. PDB has been a board member/advisory panel for Abbott Italia, Astra Zeneca Italia, Allergan/Abvie, Bayer Italia, Boehringer Italia, Eli Lilly Italia, Glaxo Italia, Menarini Diagnostic, Novonordisk Italia, Sanofi Italia and speaker bureau for Abbott Italia, Astra Zeneca Italia, Allergan/Abbvie, Ascensia Italia, Bayer Italia, Boehringer Italia, Eli Lilly Italia, Guidotti, Insulet, Menarini Diagnostic, Novonordisk Italia, Sanofi Italia, Theras Italia. RCB has received lecture fees from AstraZeneca, Eli Lilly, Sanofi, MSD, Janssen and has been a board member/advisory panel for Eli Lilly, Sanofi, MSD, Amgen. RA, GB, DR, AS, GM, AVC, VM, MB, MM, AV, MCC, APS, MA, FF have no potential conflicts of interest. No other potential conflicts of interest relevant to this article were reported.

Figures

Fig. 1
Fig. 1
Study CONSORT flow chart. Group A: naive user for FGM device; Group B: former user for FGM device
Fig. 2
Fig. 2
Incidence rates *100 person year for severe hypoglycaemia events (SHE) in the 2 groups (Group A-naive user for FGM device, white bars; Group B-former user for FGM device, gray bars) over time (3 to 12 months). Data plot represent incidence rates and bars show 95% confidence intervals
Fig. 3
Fig. 3
Time (minutes, %) in different glucose ranges: < 54 mg/dL (TBR level 2, very low, dark red), 54–69 mg/dL (TBR level 1, low, red), 70–180 mg/dL (TIR, target, green), 181–250 mg/dL (TAR level 1, high, yellow), e > 250 mg/dL (TAR level 2, high, orange) in the 2 groups (Group A-naive user for FGM device,left panel; Group B-former user for FGM device, right panel). TBR:time below range, TIR: time-in-range, TAR: time above range
Fig. 4
Fig. 4
Diabetes quality of life (DQOL) score in the 2 groups (Group A-naive user for FGM device, white boxes; Group B-former user for FGM device, gray boxes) at baseline and 12 months. Truncated violin plots extend from the minimum and maximum values and median and quartiles are shown
See this image and copyright information in PMC

References

    1. https://www.idf.org/aboutdiabetes/type-1-diabetes.html
    1. Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C, (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329:977–986. 10.1056/NEJM199309303291401 10.1056/NEJM199309303291401 - DOI - PubMed
    1. Nathan DM, Cleary PA, Backlund JY et al (2005) Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 353(25):2643–2653. 10.1056/NEJMoa052187 10.1056/NEJMoa052187 - DOI - PMC - PubMed
    1. Williams SA, Pollack MF, Dibonaventura M (2011) Effects of hypoglycemia on health-related quality of life, treatment satisfaction and healthcare resource utilization in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract 91(3):363–370. 10.1016/j.diabres.2010.12.027 10.1016/j.diabres.2010.12.027 - DOI - PubMed
    1. McCoy RG, Van Houten HK, Ziegenfuss JY, Shah ND, Wermers RA, Smith SA (2012) Increased mortality of patients with diabetes reporting severe hypoglycemia. Diabetes Care 35(9):1897–1901. 10.2337/dc11-2054 10.2337/dc11-2054 - DOI - PMC - PubMed

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