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. 2025 Mar 1;48(3):437-443.
doi: 10.2337/dc24-1833.

Time Below Range and Its Influence on Hypoglycemia Awareness and Severe Hypoglycemia: Insights From the Association of British Clinical Diabetologists Study

Harshal Deshmukh  1   2   3   4 , Emma G Wilmot  5   6 , Pratik Choudhary  7 , Emmanuel Ssemmondo  3   4 , Dennis Barnes  8 , Neil Walker  9 , Chris Walton  3 , Robert E J Ryder  10 , Thozhukat Sathyapalan  3   4
Affiliations

Time Below Range and Its Influence on Hypoglycemia Awareness and Severe Hypoglycemia: Insights From the Association of British Clinical Diabetologists Study

Harshal Deshmukh et al. Diabetes Care. .

Abstract

Objective: This study aimed to explore the relationship between time below range (TBR), impaired awareness of hypoglycemia (IAH), and severe hypoglycemia (SH).

Research design and methods: This cross-sectional study analyzed data from individuals with diabetes using continuous glucose monitors (CGMs) in the Association of British Clinical Diabetologists audit. Hypoglycemia awareness was assessed via the Gold score (≥4 denoting IAH), and SH was defined as hypoglycemia requiring third-party assistance. Logistic regression was used to determine the association between TBR percentage (<70 mg/dL; 3.9 mmol/L) at first follow-up and follow-up Gold score and SH incidence. The Youden J index identified optimal TBR percentage cutoffs for detecting IAH and SH.

Results: The study included 15,777 participants, with follow-up TBR and SH data available for 5,029. The median TBR percentage was 4% (interquartile range 2-6.6%), with 42% meeting the recommended TBR of ≤4%. Adjusted for age, sex, and BMI, TBR was significantly associated with SH (P < 0.001) and IAH (P = 0.005). Optimal TBR cutoffs for identifying IAH and SH were 3.35% and 3.95%, yielding negative predictive value (NPV) values of 85% and 97%, respectively.

Conclusions: Our findings support the international consensus recommending a TBR of <4% in type 1 diabetes, with high NPV values suggesting the utility of TBR in screening for SH.

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Conflict of interest statement

Duality of Interest. The nationwide FSL ABCD audit is supported by a grant from Abbott Laboratories. E.G.W. has received personal fees from Abbott, AstraZeneca, Dexcom, Eli Lilly, Embecta, Insulet, Medtronic, Novo Nordisk, Roche, Sanofi, Sinocare, and Ypsomed and research support from Abbott, Embecta, Insulet, Novo Nordisk, and Sanofi. C.W. has a spouse/partner serving on the advisory panel for Celgene and on the speakers bureaus for LEO Pharma and Novartis. R.E.J.R. serves on the advisory panel for Novo Nordisk and on the speakers bureau for BioQuest. T.S. reports a relationship with Bristol-Myers Squibb, Eli Lilly, and Sanofi. P.C. has received consulting fees from Medtronic, Dexcom, Insulet Corporation, Abbott Diabetes, Lilly Diabetes, and Sanofi; honoraria or payment for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Novo Nordisk, Medtronic, Insulet Corporation, Lilly Diabetes, Sanofi Diabetes, and Glooko; payment for expert testimony and support for travel and attending meetings from Abbott Diabetes; participation in data safety monitoring boards or advisory boards for Medtronic; is the chair of the Diabetes Technology Network–UK and the lead for Type 1 Diabetes Midlands UK; and was supported by National Institute for Health and Care Research (NIHR) Wellcome Trust clinical research facility at King’s College Hospital and the NIHR patient recruitment center at University Hospitals Leicester. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
A–C: ROC curves for detecting IAH and SH with TBR and baseline covariates (A), SH with TBR and GOLD score and baseline covariates (B), and SH with GOLD score and baseline covariates (C).
Figure 2
Figure 2
Diagnostic performance measures with TBR cutoff for optimal TBR cutoffs for IAH and SH.
See this image and copyright information in PMC

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