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Assessment of hypoglycaemia during basal insulin therapy: Temporal distribution and risk of events using a predefined or an expanded definition of nocturnal events

Lookup NU author(s): Emeritus Professor Philip Home

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Abstract

© 2017. Aim: To describe in type 2 diabetes the 24-hour distribution of hypoglycaemia and compare the frequency of nocturnal events based on a predefined nocturnal window or an expanded interval, using illustrative data for two insulin glargine formulations. Methods: Temporal distribution of hypoglycaemic events was assessed descriptively and by profile using participant-level data from three randomized trials comparing insulin glargine 300 U/mL (Gla-300) and 100 U/mL (Gla-100). Risk of hypoglycaemia and annualized event rates were compared for the predefined nocturnal interval (00:00 to 05:59. h) and an expanded window (22:00. h to the pre-breakfast glucose measurement). Results: Confirmed (≤. 3.9. mmol/L [≤. 70 mg/dL]) or severe hypoglycaemic events were reported most frequently between 06:00 and 10:00 h with both insulins. Nearly threefold more events were identified using the expanded nocturnal interval. Risk of ≥. 1 nocturnal event was 25% lower with Gla-300 than Gla-100 with the predefined, and 16% lower with the expanded interval; annualized event rates were 31% and 24% lower with the predefined and expanded window, respectively. The between-insulin difference in number of nocturnal events depended markedly on the chosen nocturnal interval (556 vs. 1145 fewer events with Gla-300 using the predefined vs. expanded interval). Conclusions: The predefined 00:00-05:59. h nocturnal interval excluded many hypoglycaemic events occurring during the actual overnight interval. While Gla-300 reduced hypoglycaemic events versus Gla-100 (regardless of the interval considered), the results obtained using the expanded window better reflect the clinical experience of people treated with basal insulin.

Publication metadata

Author(s): Riddle MC, Bolli GB, Avogaro A, Alvarez MG, Merino-Trigo A, Boelle-Le Corfec E, Home PD

Publication type: Article

Publication status: Published

Journal: Diabetes and Metabolism

Year: 2018

Volume: 44

Issue: 4

Pages: 333-340

Print publication date: 01/09/2018

Online publication date: 11/12/2017

Acceptance date: 03/12/2017

Date deposited: 17/01/2018

ISSN (print): 1262-3636

ISSN (electronic): 1878-1780

Publisher: Elsevier Masson SAS

URL: https://doi.org/10.1016/j.diabet.2017.12.001

DOI: 10.1016/j.diabet.2017.12.001

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