Abstract
Objective
Hypoglycemia is common in type 1 diabetes mellitus (T1DM). We aimed to update the incidence of severe and symptomatic hypoglycemia and investigate several correlated factors.
Methods
In this multicenter, observational retrospective study, the data of 206 T1DM patients from a sample of 2,229 consecutive patients seen at 18 diabetes clinics were analyzed. Sociodemographic and clinical characteristics, severe hypoglycemia in the past 12 months, and symptomatic hypoglycemia in the past 4 weeks were recorded with a self-report questionnaire and a clinical form during a routine visit. Poisson multivariate models were applied.
Results
A minority of patients accounted for the majority of both severe and symptomatic episodes. The incidence rate (IR) of severe hypoglycemia was 0.49 (0.40–0.60) events/person-years. The incidence rate ratio (IRR) was higher in patients with previous severe hypoglycemia (3.71; 2.28–6.04), neuropathy (4.16; 2.14–8.05), long duration (>20 years, 2.96; 1.60–5.45), and on polypharmacy (1.24; 1.13–1.36), but it was lower when a complication was present. The IR of symptomatic hypoglycemia was 53.3 events/person-years, with an IRR significantly higher among women or patients with better education, or shorter duration or on pumps. The IRR was lower in patients with higher BMI or neuropathy or aged more than 50 years.
Conclusions
Fewer than 20 % of T1DM patients are free from hypoglycemia, with one in six having experienced at least one severe episode in the last year. The distribution is uneven, with a tendency of episodes to cluster in some patients. Severe and symptomatic episodes have different correlates and reflect different conditions.
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Acknowledgments
This study was organized and funded by the AMD Foundation Rome, with an unrestricted grant from Novo Nordisk.
Conflict of interest
Carlo B Giorda, Alessandro Ozzello, Sandro Gentile, Alberto Aglialoro, Anna Chiambretti, Fabio Baccetti, Francesco M. Gentile, Giuseppe Lucisano, Antonio Nicolucci and Maria Chiara Rossi declare that they have no conflict of interest.
Ethical standard
This study was approved by Institutional Interdipartimental Ethics Committee S. Luigi Hospital of Orbassano, Italy.
Human and animal rights
All procedures were carried out in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 [5].
Informed consent
Informed consent was obtained from all patients for being included in the study.
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Managed by Massimo Federici.
Please refer the “Appendix” section for HYPOS-1 Study Group of AMD investigators list.
Appendix: HYPOS-1 study group of AMD investigators
Appendix: HYPOS-1 study group of AMD investigators
R. Fornengo—Chivasso(TO), A. Alessiato—Chieri (TO), A. Ozzello—Pinerolo (TO), L. Sciangula—Mariano Comense (CO), N. Musacchio—Cusano Milanino (MI), G. Marelli—Desio (MB), A. Corsi—Sanpierdarena (GE), F. Baccetti—Massa (MS), V. Paciotti—Avezzano (AQ), R. Iannarelli L’Aquila (AQ), D. Antenucci—Lanciano (CH), F. Chiaramonte—Roma, S. Leotta—Roma, S. Gentile- Napoli, V. Armentano—Napoli, F.M. Gentile—Rutigliano (BA), F. Mastinu—Oristano (OR) and D. Cucinotta—Messina.
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Giorda, C.B., Ozzello, A., Gentile, S. et al. Incidence and risk factors for severe and symptomatic hypoglycemia in type 1 diabetes. Results of the HYPOS-1 study. Acta Diabetol 52, 845–853 (2015). https://doi.org/10.1007/s00592-015-0713-4
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DOI: https://doi.org/10.1007/s00592-015-0713-4