Trial reportBMJ paediatrics open2026
Impact of flash glucose monitoring versus capillary blood glucose monitoring on glycaemia in Indian youth with type 1 diabetes: a randomised crossover study.
Trial report in BMJ paediatrics open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
backgroundData relating to flash glucose monitoring (FGM) use in low-resource settings are limited. Our study investigated the impact of FGM versus self-monitoring of blood glucose (SMBG) on glycaemia in Ahmedabad, India.
methodsA randomised crossover study of FGM versus SMBG was undertaken. Participants aged 10-25 years (type 1 diabetes (T1D)>1 year) were randomised 1:1 to either Freestyle Libre 1 FGM use (intervention) for 6 months, followed by SMBG≥4 times/day (local care standard) for 6 months; or SMBG≥4 times/day, followed by FGM. After 12 months, everyone entered a 6-month observation period using the monitoring method choice. Insulin and dietary adjustments were undertaken as per local care standards. Glycated haemoglobin (HbA1c) was measured at 0, 3 and 6 months (period 1) and 9 and 12 months (period 2). Analyses included use of linear mixed-effects analysis of covariance, a paired Wilcoxon signed-rank test, and cumulative link mixed tests and model.
resultsOf 106 participants, 91 (86%) completed 12 months follow-up (47.3% female). At baseline, mean±SD age was 17.8±3.8 years, diabetes duration 9.9±5.0 years and HbA1c 8.6±1.9% (70±21 mmol/mol).HbA1c decreased when using FGM versus SMBG (difference -0.44% (4.8 mmol/mol); p=0.006), with greater reduction in those with higher baseline HbA1c (p=0.003). In the FGM→SMBG group, HbA1c initially decreased from 8.6±2.2% (70±24 mmol/mol) to 7.9±1.1% (62±12 mmol/mol) at 3 and 6 months (both p<0.05). After SMBG crossover, HbA1c was unchanged (7.9±1.1% (63±12 mmol/mol) at 9 months and 8.1±1.3% (65±14 mmol/mol) at 12 months). In the SMBG→FGM group, HbA1c was initially stable (8.6±1.4% (70±15 mmol/mol) at baseline; 8.8±1.7% (73±19 mmol/mol) at 6 months), but decreased after crossover to FGM (8.4±1.4% (68±15 mmol/mol) at 9 months; 8.3±0.9% (67±10 mmol/mol) at 12 months; p=0.023).
conclusionThis study provides evidence of improvement in glycaemic outcomes while using FGM in youth living with T1D in India. TRIAL REGISTRATION NUMBER: Clinical Trial Registry of India (CTRI/2022/02/020175).
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