Intermittently scanned continuous glucose monitoring in adults with type 1 diabetes: A subgroup analysis from the FLASH‐UK study

Author:

Leelarathna Lalantha12,Sutton Christopher J.34,Evans Mark L.5,Neupane Sankalpa6,Rayman Gerry7,Lumley Sarah8,Cranston Iain9,Narendran Parth10ORCID,Krishan Ashma3,Taxiarchi Vicky P.11,Barnard‐Kelly Katharine12ORCID,Elliott Rachel A.13ORCID,Burns Matthew4,Camm Maisie1,Thabit Hood12ORCID,Wilmot Emma G.1415,

Affiliation:

1. Manchester Diabetes Centre, Manchester Royal Infirmary Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre Manchester UK

2. Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health University of Manchester Manchester UK

3. Centre for Biostatistics, Division of Population Health, Health Services Research & Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health University of Manchester Manchester UK

4. Manchester Clinical Trials Unit, Division of Population Health, Health Service Research & Primary Care University of Manchester Manchester UK

5. Wellcome Trust‐MRC Institute of Metabolic Science, NIHR Cambridge Biomedical Research Centre Cambridge University Hospitals and University of Cambridge Cambridge UK

6. Elsie Bertram Diabetes Centre Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich UK

7. The Diabetes and Endocrine Centre, Ipswich Hospital East Suffolk and North Essex NHS Foundation Trust Ipswich UK

8. The Adam Practice Dorset UK

9. Academic Department of Diabetes and Endocrinology Queen Alexandra Hospital Cosham, Portsmouth UK

10. Institute of Immunology and Immunotherapy, College of Medical and Dental Sciences University of Birmingham Edgbaston, Birmingham UK

11. Centre for Women's Mental Health, Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health University of Manchester Manchester UK

12. Barnard Health BHR Limited Hampshire UK

13. Manchester Centre for Health Economics, Division of Population Health, Health Service Research & Primary Care University of Manchester Manchester UK

14. University of Nottingham Nottingham UK

15. University Hospitals of Derby and Burton NHS Foundation Trust Royal Derby Hospital Derby UK

Abstract

AbstractAimsThe FLASH‐UK trial showed lower HbA1c with intermittently scanned continuous glucose monitoring (isCGM), as compared with self monitoring of blood glucose (SMBG), in adults with type 1 diabetes and HbA1c ≥58 mmol/mol (≥7.5%). Here, we present results from the pre‐specified subgroup analysis for the 24‐week HbA1c (primary outcome) and selected sensor‐based secondary outcomes.MethodsThis was a multi‐centre, parallel‐design, randomised controlled trial. The difference in treatment effect between subgroups (baseline HbA1c [≤75 vs. >75 mmol/mol] [≤9.0 vs >9.0%], treatment modality [pump vs injections], prior participation in structured education, age, educational level, impaired awareness of hypoglycaemia, deprivation index quintile sex, ethnic group and Patient Health Questionnaire‐9 [PHQ‐9] detected depression category) were evaluated.ResultsOne hundred fifty‐six participants (females 44%, mean [SD] baseline HbA1c 71 [9] mmol/mol 8.6 [0.8%], age 44 [15]) were randomly assigned, in a 1:1 ratio to isCGM (n = 78) or SMBG (n = 78). The mean (SD) baseline HbA1c (%) was 8.7 (0.9) in the isCGM group and 8.5 (0.8) in the SMBG group, lowering to 7.9 (0.8) versus 8.3 (0.9), respectively, at 24 weeks (adjusted mean difference −0.5, 95% confidence interval [CI] −0.7 to −0.3; p < 0.001]. For HbA1c, there was no impact of treatment modality, prior participation in structured education, deprivation index quintile, sex or baseline depression category. The between‐group difference in HbA1c was larger for younger people (a reduction of 2.7 [95% CI 0.3–5.0; p = 0.028] mmol/mol for every additional 15 years of age). Those with HbA1c 76–97 mmol/mol (>9.0%–11.0%) had a marginally non‐significant higher reduction in HbA1c of 8.4 mmol/mol (3.3–13.5) compared to 3.1 (0.3–6.0) in those with HbA1c 58–75 mmol/mol (p = 0.08). For ‘Time in range’ (% 3.9–10 mmol/L), the difference was larger for those with at least a bachelor's degree. For ‘Time below range’ (% <3.9 mmol/L), the difference was larger for those using injections, older people and those with less than bachelor's degree.ConclusionsIntermittently scanned continuous glucose monitoring is generally effective across a range of baseline characteristics.

Funder

Diabetes UK

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

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