Dose-Normalised Time in Range (dn-TIR) Improves Following Hybrid Closed-Loop (HCL) Therapy in Type 1 Diabetes: A Real-World Cohort Study From Australia and the United Kingdom.
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Abstract
Objective: To evaluate dose-normalised time in range (dn-TIR) and its log relative change (Δdn-TIR) as measures of within-person glycaemic change relative to total daily insulin exposure following hybrid closed-loop therapy (HCL/AID).
Research design and methods: We conducted a retrospective two-cohort study of people with type 1 diabetes commencing hybrid closed-loop/automated insulin delivery (HCL/AID) therapy in Australia and the United Kingdom (UK). dn-TIR was calculated as time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) divided by total daily insulin dose (TDD) and Δdn-TIR as log[(TIR/TDD)post/(TIR/TDD)pre].
Results: The study comprised 86 people living with type 1 diabetes in Australia and 288 in the UK. In the fixed Australian dn-TIR cohort, TIR increased from 53.2% ± 20.7% to 70.4% ± 14.6% (n = 86; p < 0.001), whereas mean TDD changed from 53.3 to 52.0 units/day (n = 86; p = 0.724). Median Δdn-TIR was 0.224 [IQR: -0.033, 0.583]. In the UK cohort, TIR increased from a median 54% [34, 68] to 66% [54, 74] (n = 257; p < 0.001), whereas mean TDD changed from 44.1 to 46.3 units/day (n = 242; p = 0.152). Median Δdn-TIR was 0.194 [IQR: -0.097, 0.541].
Conclusions: HCL/AID therapy improved TIR relative to TDD in two real-world cohorts. dn-TIR and Δdn-TIR are not replacements for established CGM metrics or direct measures of insulin sensitivity; they may provide an adjunct longitudinal description of whether glycaemic improvement was accompanied by proportionately greater, similar or lower insulin exposure.
期刊介绍：
Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.
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