Ian Gordon1, Carolyn Rutherford2, Kelly Makarounas-Kirchmann3, Matt Kirchmann4. 1. Statistical Consulting Centre, School of Mathematics and Statistics, University of Melbourne, Victoria 3010, Australia. Electronic address: irg@unimelb.edu.au. 2. KMC Health Care, 45 Alicudi Avenue, Frankston South, Victoria 3199, Australia. Electronic address: carolyn@kmchealthcare.com. 3. KMC Health Care, 45 Alicudi Avenue, Frankston South, Victoria 3199, Australia. Electronic address: kelly@kmchealthcare.com. 4. KMC Health Care, 45 Alicudi Avenue, Frankston South, Victoria 3199, Australia. Electronic address: matt@kmchealthcare.com.
Abstract
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.
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.
Authors: Anita Jeyam; Fraser W Gibb; John A McKnight; Joseph E O'Reilly; Thomas M Caparrotta; Andreas Höhn; Stuart J McGurnaghan; Luke A K Blackbourn; Sara Hatam; Brian Kennon; Rory J McCrimmon; Graham Leese; Sam Philip; Naveed Sattar; Paul M McKeigue; Helen M Colhoun Journal: Diabetologia Date: 2021-10-07 Impact factor: 10.122
Authors: Isabel Leiva-Gea; Maria F Martos-Lirio; Ana Gómez-Perea; Ana-Belen Ariza-Jiménez; Leopoldo Tapia-Ceballos; Jose Manuel Jiménez-Hinojosa; Juan Pedro Lopez-Siguero Journal: J Clin Med Date: 2022-01-06 Impact factor: 4.241