CGM USE ASSOCIATED WITH REDUCTION IN ACUTE DIABETES COMPLICATIONS, EVEN IN PATIENTS USING LESS THAN FOUR TEST STRIPS PER DAY
Abstract
Background and Aims
Continuous glucose monitors (CGMs) simplify diabetes management by removing need for multiple daily finger-stick blood samples. We aim to describe CGM real-world clinical outcomes in patients with Type 1 and Type 2 diabetes (T1D, T2D), including those using less than four test-strips (L4S) pre-CGM.
Methods
IBM MarketScan™ Commercial Claims and Medicare Supplemental databases, 2016 Q1–2018 Q3, were used in this retrospective, observational analysis. MarketScan™ contains insurance billing claims for inpatient, outpatient, and pharmacy expenses. De novo CGM-users with fast-acting insulin, test strip purchases, and ≥ 6-months pre-CGM observation time were selected. L4S was defined as <4 strips/day over 6 months pre-CGM. Primary outcome was acute diabetes complication events per patient-year (ev/pt-yr) due to hyper-/hypoglycemia occurring in an inpatient or emergency outpatient setting. Andersen-Gill Cox regression compared event rates 6-months pre-/post-CGM.
Results
The overall T1D cohort (n=7,648, age 33.6±18.4 years, 49.7% male) experienced a reduction in acute diabetes complications from 0.37 to 0.15 ev/pt-yr (HR: 0.39 [0.35 0.43]; P:<0.001). A similar reduction was seen in the T1D L4S subset (n=4,211, 0.43 to 0.18 ev/pt.-yr, HR: 0.40 [0.36 0.46]; P:<0.001). The overall T2D cohort (n=1,129, age 53.6±13.1 years, 54.8% male) also saw a significant reduction in events from 0.23 to 0.10 ev/pt-yr (HR: 0.45 [0.33 0.62]; P:<0.001), as did the T2D L4S cohort (n=836, 0.22 to 0.11 ev/pt-yr, HR: 0.50 [0.35 0.72]; P:<0.001).
Conclusions
Lower acute diabetes complications post-CGM purchase support the real-world effectiveness of CGMs, even in diabetics with history of lower test-strip usage.
MANAGING DIABETES IN A ‘FLASH’: EFFECT OF 6 MONTHS’ FLASH GLUCOSE MONITORING IN ADOLESCENTS WITH HIGH-RISK GLYCAEMIC CONTROL – A RANDOMISED CONTROLLED TRIAL
Abstract
Background and Aims
To investigate whether flash glucose monitoring (FGM) significantly improves glycaemic control compared with traditional self-monitored capillary blood glucose (SMBG) in adolescents and young adults with high risk glycaemic control and type 1 diabetes (T1D).
Methods
This 6-month randomized, industry independent, two-arm, parallel, controlled, multi-center open-label study included adolescents with type 1 diabetes, and glycated haemoglobin (HbA1c) ≥ 75mmol/mol (9%). Patients were randomly assigned to either an intervention group (FGM; FreeStyle Libre, Abbott) or a control group (SMBG), in a 1:1 ratio. The primary outcome was change in HbA1c from baseline to 6 months.
Results
In an intent-to-treat analysis of 64 participants (mean ± SD age 16.6 ± 2.1; 33 male), 33 participants were randomized to FGM and 31 participants to control. Baseline HbA1c was 94.0 ± 18.0 mmol/mol (10.8 ± 3.8%) and 98.8 ± 17.8 (11.2 ±3.8 %) in the FGM and SMBG groups, respectively. At 6 months, HbA1c decreased in both groups (86.1 ± 16.5 [10.0 ± 3.7%] and 93.2 ± 15.9 [10.7 ± 3.6%] in the FGM and SMBG groups, respectively) with no evidence of differences in changes between groups (adjusted mean 2.1 mmol/mol greater improvement for FGM, 95% CI -5.4 to 9.6, p=0.576). Total glucose testing frequency increased in the FGM group, performing 2.8 more glucose checks/day compared to SMBG (p<0.001).
Conclusions
Despite demonstrating an increase in glucose testing behaviour, this study provides no evidence that FGM alone improves glycemic outcomes over SMBG in adolescents and young adults with high risk glycemic control.
IMPACT OF TWO DIFFERENT COMPARISON METHODS ON APPARENT SYSTEM ACCURACY OF 18 CE-MARKED CURRENT-GENERATION SELF-MONITORING BLOOD GLUCOSE SYSTEMS
Abstract
Background and Aims
Systems for self-monitoring of blood glucose (SMBG) have to be sufficiently accurate for effective glycemic control. In accuracy studies, the selected comparison method can influence the apparent level of measurement accuracy. This study aimed at assessing the impact of two different comparison methods on the apparent accuracy of 18 CE-marked current-generation SMBG systems.
Methods
Measurement accuracy was assessed in a setting based on ISO 15197:2013 and additional analyses were performed, including minimal deviation within which 95% of results were found, relative bias, and mean absolute relative difference (MARD). Comparison measurements were performed on a glucose oxidase-based (GOD) and a hexokinase-based (HK) method in parallel.
Results
While ≈80% of SMBG systems met the accuracy criteria of ISO 15197 (i.e., ≥95% of results found within ±15 mg/dl or ±15% of comparison method results) when compared to the manufacturers reference method, only ≈67% did so independently from the applied comparison method. The minimal deviation within which 95% of results were found ranged from 7.7 to 19.7 mg/dl or % (GOD-based method) and from 5.3 to 20.1 mg/dl or % (HK-based method). The mean relative bias ranged from -6.6% to +5.7% (GOD-based method) and from -11.1% to +1.3% (HK-based method), whereas MARD results ranged from 3.7% to 9.8% and from 2.3% to 10.5%, respectively.
Conclusions
The results of this study indicate that the selected comparison measurement method may have an appreciable impact on SMBG systems’ apparent level of accuracy. Therefore, further steps towards harmonization of comparison method results are important.
CORRELATION BETWEEN TIME IN RANGE AND GLUCOSE MANAGEMENT INDICATOR WITH THE EVERSENSE CGM SYSTEM
Abstract
Background and Aims
The safety and accuracy outcomes from multiple clinical studies of the implantable Eversense CGM System allowed for CE Marking in 2016 and FDA approval in 2018. Glucometric, accuracy, and safety data from the first 205 US real-world users has been reported and shown to corroborate clinical study results.
Methods
De‐identified sensor glucose (SG) data from the Eversense data management system (DMS) from an expanded cohort of 582 real-world commercial users who reached the end of the 90‐day sensor wear period were analyzed. Correlations between Glucose Management Indicator (GMI, an SG-derived assessment of A1C) and percent of SG values between 70-180mg/dL (TIR), percent SG values >180mg/dL, and percent SG values <70mg/dL were made.
Results
As shown in the graphs, GMI had a strong negative correlation with TIR with an R2 value of 0.87. The R2 values were 0.96 for time >180mg/dL, and 0.20 for time <70mg/dL. It was calculated that a TIR increase of 10% was associated with a decrease in GMI of 0.43%.
Conclusions
Data from a large cohort of Eversense CGM system users showed a strong correlation between TIR and GMI, a mathematical assessment of A1C. Monitoring and targeting TIR, in addition to percent of SG values in the hyperglycemic range, should help patients improve diabetes long-term outcomes, particularly in between laboratory assessments of A1C.