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

Abstract

Aims: The 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. Methods: This 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. Results: One 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. Conclusions: Intermittently scanned continuous glucose monitoring is generally effective across a range of baseline characteristics.