Diabetes research and clinical practice · 2020
Meta-analysis of average change in laboratory-measured HbA1c among people with type 1 diabetes mellitus using the 14 day Flash Glucose Monitoring System.
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Gordon Ian, Rutherford Carolyn, Makarounas-Kirchmann Kelly, Kirchmann Matt
Аннотация
AIM: FreeStyle Libre™ Flash Glucose Monitoring System (Flash GM), a novel, sensor-based, factory-calibrated system has been compared with self-monitoring of blood glucose in a well-controlled adult type 1 diabetes mellitus (T1D) population (HbA1c ≤ 7.5%, 58 mmol/mol), in a randomized controlled trial (RCT). The need for RCTs to recruit homogenous patients and for a well-controlled environment may not necessarily reflect use of a new technology in real clinical practice.
METHODS: A random effects meta-analysis of all identified studies in T1D was performed to investigate changes in laboratory-measured HbA1c following introduction of Flash GM.
RESULTS: Flash GM introduction showed a mean change from baseline to longest follow-up timepoint of -0.41% ([95% CI -0.51%, -0.31%]; P < 0.001; -4.5 [95% CI -5.6, -3.3] mmol/mol) in HbA1c in the random effects meta-analysis (34 studies comprising 5,466 participants). When the Flash GM arms of the two RCTs were excluded, there was a similar change in HbA1c of -0.41% ([95% CI -0.50%, -0.32%], P < 0.001; -4.5 [95% CI -5.4, -3.5] mmol/mol) in the 32 uncontrolled studies. Considerable heterogeneity was shown in all meta-analyses (I2 values > 85%), likely due to the inclusion of diverse populations and variations in study protocols, meaning random effects meta-analyses should be strongly preferred.
CONCLUSIONS: In people with T1D, use of Flash GM for 2 to 24 months was associated with an estimated HbA1c reduction from baseline of 0.4%. A similar reduction occurred in uncontrolled studies where baseline HbA1c was generally higher compared with Flash GM arms of well-controlled studies.
METHODS: A random effects meta-analysis of all identified studies in T1D was performed to investigate changes in laboratory-measured HbA1c following introduction of Flash GM.
RESULTS: Flash GM introduction showed a mean change from baseline to longest follow-up timepoint of -0.41% ([95% CI -0.51%, -0.31%]; P < 0.001; -4.5 [95% CI -5.6, -3.3] mmol/mol) in HbA1c in the random effects meta-analysis (34 studies comprising 5,466 participants). When the Flash GM arms of the two RCTs were excluded, there was a similar change in HbA1c of -0.41% ([95% CI -0.50%, -0.32%], P < 0.001; -4.5 [95% CI -5.4, -3.5] mmol/mol) in the 32 uncontrolled studies. Considerable heterogeneity was shown in all meta-analyses (I2 values > 85%), likely due to the inclusion of diverse populations and variations in study protocols, meaning random effects meta-analyses should be strongly preferred.
CONCLUSIONS: In people with T1D, use of Flash GM for 2 to 24 months was associated with an estimated HbA1c reduction from baseline of 0.4%. A similar reduction occurred in uncontrolled studies where baseline HbA1c was generally higher compared with Flash GM arms of well-controlled studies.