Introduction Evidence supporting use of continuous glucose monitoring in type 2 diabetes treated with basal insulin is unclear. This real-world study aimed to assess the impact on glycated hemoglobin (HbA1c) of flash glucose monitoring use in adults with type 2 diabetes managed with basal insulin. Research design and methods Medical records were reviewed for adult individuals with type 2 diabetes using basal insulin for ≥1 year with or without additional antihyperglycemic medication, HbA1c 8.0%–12.0% prior to FreeStyle Libre Flash Glucose Monitoring use for ≥90 days and an HbA1c measurement recorded between 90 and 194 days after device use. Exclusion criteria included utilization of bolus insulin. Meta-analysis data are from the current study (USA) and a similar Canadian cohort. Results Medical record analysis (n=100) from 8 USA study sites showed significant HbA1c decrease of 1.4%±1.3%, from 9.4%±1.0% at baseline to 8.0%±1.2% after device use, p<0.0001 (mean±SD). Meta-analysis of medical records from USA and Canada sites (n=191) showed HbA1c significantly decreased by 1.1%±0.14% (mean±SE), from baseline 9.2%±1.0% to 8.1%±1.1%, p≤0.0001, with moderate to high heterogeneity between sites (Q=43.9, I2=74.9, p<0.0001) explained by differences in baseline HbA1c between sites. The HbA1c improvement in both groups was observed by age group, body mass index, duration of insulin use and sex at birth. Conclusions In a real-world retrospective USA study and a meta-analysis of a larger USA and Canada cohort, HbA1c significantly reduced in basal insulin-treated type 2 diabetes, without bolus insulin initiation and following the commencement of flash glucose monitoring technology.
Introduction Evidence supporting use of continuous glucose monitoring in type 2 diabetes treated with basal insulin is unclear. This real-world study aimed to assess the impact on glycated hemoglobin (HbA1c) of flash glucose monitoring use in adults with type 2 diabetes managed with basal insulin. Research design and methods Medical records were reviewed for adult individuals with type 2 diabetes using basal insulin for >= 1 year with or without additional antihyperglycemic medication, HbA1c 8.0%-12.0% prior to FreeStyle Libre Flash Glucose Monitoring use for >= 90 days and an HbA1c measurement recorded between 90 and 194 days after device use. Exclusion criteria included utilization of bolus insulin. Meta-analysis data are from the current study (USA) and a similar Canadian cohort. Results Medical record analysis (n=100) from 8 USA study sites showed significant HbA1c decrease of 1.4%+/- 1.3%, from 9.4%+/- 1.0% at baseline to 8.0%+/- 1.2% after device use, p<0.0001 (mean +/- SD). Meta-analysis of medical records from USA and Canada sites (n=191) showed HbA1c significantly decreased by 1.1%+/- 0.14% (mean +/- SE), from baseline 9.2%+/- 1.0% to 8.1%+/- 1.1%, p <= 0.0001, with moderate to high heterogeneity between sites (Q=43.9, I-2=74.9, p<0.0001) explained by differences in baseline HbA1c between sites. The HbA1c improvement in both groups was observed by age group, body mass index, duration of insulin use and sex at birth. Conclusions In a real-world retrospective USA study and a meta-analysis of a larger USA and Canada cohort, HbA1c significantly reduced in basal insulin-treated type 2 diabetes, without bolus insulin initiation and following the commencement of flash glucose monitoring technology.
This retrospective, real-world, chart review study determined the effectiveness of the FreeStyle Libre® Flash Glucose Monitoring System on HbA1c when used by adults with type 2 diabetes (T2D) in a real-world setting between 3 months to 6 months after starting FreeStyle Libre. The study population included adults on a basal insulin regimen for at least 1 year, with HbA1c between 8.0 and 12.0% (64 to 108 mmol/mol), using FreeStyle Libre regularly for at least 3 months. Pregnant patients were excluded, as were patients on dialysis. A total of 100 records from basal insulin using patients with T2D from 8 clinical sites in the US were included in this chart review. Mean HbA1c was 9.4±1.0% (79.2±11.1 mmol/mol), prior to FreeStyle Libre use, age was 56.0±10.3 years, BMI was 36.1±7.8 kg/m2 and average duration of insulin use 4.5±3.5 years (mean±SD); 96.0% of patients were on oral anti-diabetic medications in addition to basal insulin and 52.0% were male. HbA1c results were recorded between 90 to 194 days from the start of use of FreeStyle Libre, between December 2017 and March 2020. To minimise selection bias records were selected on a systematic basis. After at least 3 months of using FreeStyle Libre in addition to their usual clinical care, HbA1c (primary outcome) was significantly reduced by 1.4±1.3% (mean±SD); p<0.0001. Sub-group analysis by baseline HbA1c (<9.0%, ≥9.0%) showed both groups significantly reduced HbA1c; with reductions of 0.8±0.7%, p<0.0001 and 1.7±1.4%, p<0.0001, respectively. This real-world, chart review study concluded that people with T2D on basal insulin therapy, using FreeStyle Libre for between 3 to 6 months significantly reduced HbA1c. Disclosure A. L. Carlson: Board Member; Self; JDRF, Other Relationship; Self; Medtronic, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Omnipod, Sanofi, UnitedHealth Group. T. D. Daniel: Advisory Panel; Self; Abbott Diabetes, Bayer Healthcare Pharmaceuticals Inc. A. Desantis: None. S. Jabbour: None. E. Karslioglu-french: None. D. F. Kruger: Advisory Panel; Self; Abbott Diabetes, Novo Nordisk, Sanofi US, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Novo Nordisk, Speaker’s Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Stock/Shareholder; Self; Pendulum Therapeutics. E. Miller: Advisory Panel; Self; Abbott Diabetes, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk Inc., Research Support; Self; Pendulum Therapeutics, Research Support; Spouse/Partner; Abbott Diabetes. K. Ozer: Research Support; Self; Abbott Diabetes, AbbVie Inc., Eli Lilly and Company, Novo Nordisk, Senseonics, Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk. Funding Abbott Diabetes Care
Two retrospective chart review studies evaluated the effectiveness of the FreeStyle Libre® Flash Glucose Monitoring System on HbA1c when used by adults with type 2 diabetes (T2D) in a real-world setting. Each study aimed to determine the effect of FreeStyle Libre when used for between 3 months to 6 months on HbA1c. Each study population included adults on a basal insulin regimen for at least 1 year who had been using FreeStyle Libre regularly for at least 3 months and with HbA1c between 8.0 and 12.0% (64 to 108 mmol/mol). Pregnant patients were excluded, as were patients on dialysis. This meta-analysis comprised of a total of 191 records from basal insulin using patients with T2D from 14 medical centers across Canada and the US. On average, HbA1c was 9.2±1.0% (76.8±10.7 mmol/mol) prior to FreeStyle Libre use, age was 60.0±11.3 years and average duration of insulin use 4.3±3.3 years (mean±SD), 95.8% of patients were on oral antidiabetic medications and 60.2% were male. Renal and CVD complications were reported by 31.4% and 28.3% of patients, respectively. HbA1c results were recorded between 90 and 194 days from the start of use of FreeStyle Libre, between December 2017 and March 2020. Overall mean change in HbA1c, after at least 3 months of using FreeStyle Libre, was significantly reduced by 1.1±0.14% (mean±SE); p<0.0001, with moderate to high heterogeneity between centers (Q=43.9, I2=74.9, p<0.0001) explained by differences in initial HbA1c between centers. No significant differences were detected between: age group, sex, BMI or duration of insulin use. This meta-analysis of two real-world, chart review studies concludes that people with T2D on basal insulin therapy, using FreeStyle Libre for between 3 to 6 months significantly reduced HbA1c. Disclosure A. L. Carlson: Board Member; Self; JDRF, Other Relationship; Self; Medtronic, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Omnipod, Sanofi, UnitedHealth Group. T. D. Daniel: Advisory Panel; Self; Abbott Diabetes, Bayer Healthcare Pharmaceuticals Inc. A. Desantis: None. S. Jabbour: None. E. Karslioglu-french: None. D. F. Kruger: Advisory Panel; Self; Abbott Diabetes, Novo Nordisk, Sanofi US, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Novo Nordisk, Speaker’s Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Stock/Shareholder; Self; Pendulum Therapeutics. E. Miller: Advisory Panel; Self; Abbott Diabetes, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk Inc., Research Support; Self; Pendulum Therapeutics, Research Support; Spouse/Partner; Abbott Diabetes. K. Ozer: Research Support; Self; Abbott Diabetes, AbbVie Inc., Eli Lilly and Company, Novo Nordisk, Senseonics, Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk. T. Elliott: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk, Other Relationship; Self; Abbott Diabetes. Funding Abbott Diabetes Care
IN BRIEF Glucose variability is a potential independent risk factor of poor clinical outcome among people with diabetes, with adequate measurement technically difficult and cumbersome. For this study, a novel 14-day continuous sensor was used to assess glucose variability among people with type 2 diabetes (T2D). The aim was to characterize glucose profiles for up to 2 weeks in T2D and to survey device utilization in a standard clinical setting and its potential to collect clinically meaningful data.