The seventh-generation (G7) continuous glucose monitor provides accurate and safe glucose readings during 10.5 days of use among adults that have diabetes.
Developments in diabetes technology in the past years include continuous glucose monitoring (CGM) systems, insulin delivery devices, and hybrid and closed-loop systems. Continuous glucose monitoring systems have been commonly used among people with diabetes to maintain their blood sugar levels. Earlier studies show that the presently used G6 CGM gives the correct glucose level measurement in the blood among adults and children. G6 CGM gives the value of the glucose within five minutes, which can be utilized in the treatments of diabetes. Another advantage of this system is optional user calibrations, user personalized alerts and settings, and Bluetooth for data transmission up to 20 feet. A seventh-generation Dexcom (G7) continuous glucose monitor was produced to improve the performance of the G6 CGM device. A new study by Garg and colleagues suggests Dexcom G7 CGM gives a correct or better reading for a patient with diabetes than the presently used CGM device in the market. G7 CGM is currently being evaluated by the US Food and Drug Administration (FDA), and it is expected to be an advanced version of Dexcom G6 in many ways. G7 has more advanced features than G6, such as an on-body size of 60% smaller than G6; each of its sensors has its single-use transmitter versus the current separate 3-month transmitter used with the G6 sensor. Its automated session uses a 27 min warm period after insertion compared with 2 hours warm-up period of G6. Also, the receiver can generate 24 hours of missed data. In this new study, the outcome of sensors worn on the arm and abdomen was evaluated during the 10.5-day wear period; wear, removal, various glucose concentration ranges, changes in glucose level were noted, and undesired events associated with sensor insertion were also reported in the study.
Garg and colleagues conducted this study at 12 sites in the United States. Written informed consent was obtained from participants before the study initiation between February and June 2021. It was a multicenter, single-armed study. Three hundred eighteen adults aged 18–78 years were enrolled in this study. Adults who have either type 1 or type two diabetes, and who either were on insulin therapy or not were included in this study. Participants were recruited without considering race, gender, or body mass index (BMI). Inclusion criteria were agreeing to wear about three G7 devices for the total period of the study and adhering to not injecting insulin, and wearing an insulin pump infusion set within 3 inches of the site of insertion. Participants were excluded if they had skin conditions at the sensor insertion site and other medical issues that could affect the patient or staff safety. In-Clinic visits were performed on days 1 or 2, 4, or 7, and the addition of another day for frequent comparison with a reference measurement was generated with the use of the YSI 2300 Stat Plus glucose analyzer. Participants were made to wear sensors on the upper and lower abdomen. Accuracy benchmark incorporates proportion of Continuous Glucose Monitoring within 15% of comparator glucose levels >100 mg/dL or within 15 mg/dL of comparator levels ≤100 mg/dL (%15/15), as well as the %20/20 and %30/30 agreement rates. The calculation was also performed for the mean absolute relative difference (MARD) between temporally matched CGM and comparator values.
Three hundred sixteen adult participants using insulin with type 1 or type 2 diabetes contributed data from 308 and 311 for arm and abdomen-placed blinded sensors, respectively, which resulted in 77,774 matched pairs of data within the blood glucose 40-400 mg/dL reportable range. G7 generated a precise blood glucose measurement of the mean absolute relative difference of 8.2% and 9.1% for arm and abdomen placed devices, respectively. Also, over the time duration of wear, the glucose concentration level and rates of change were 9% accurate. Previously reported G7 data agrees with this study because Dexcom reported 8.2% and 8.1% MARD in adults and pediatrics. Overall, there were no serious adverse events observed in this study.
In conclusion, G7 CGM reported in this pivotal study shows that it is safe and effective when inserted on the upper arm or abdomen of adults who have diabetes. The advantage of G7 over G6 is that it is remarkably smaller than G6 (by 60%) and has fewer components. It offers high detection of changes in blood sugar levels, which can assist users in better controlling their glycemic value. It is also easier to use when compared with G6. Its new features may influence its use clinically, encourage its long-term use, and alleviate the burden of managing diabetes.
Practice Pearls:
- The G7 CGM pivotal study shows that it is accurate and safe to use among adults with diabetes.
- G7 improved features may increase clinical use, encourage sustained use, and alleviate the challenges of diabetes management.
- Providers might find G7 helpful because it offers real-time remote monitoring functions to caregivers and medical providers.
Garg SK, Kipnes M, Castorino K, et al. Accuracy and safety of Dexcom G7 continuous glucose monitoring in adults with diabetes. Diabetes Technology & Therapeutics. 2022. doi:10.1089/dia.2022.0011
Janet Falade, PharmD Candidate, South College School of Pharmacy
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