Introduction: FDA guidance recommends continuous glucose monitoring (CGM) for diabetes clinical trials. Real-time monitoring in such trials demands high-speed data frameworks. Here, we sought to develop a fully GxP-compliant platform that integrates with CGM devices and rapidly transmits regulatory submission quality data to study servers.
Methods: Software acquired glucose readings directly from Dexcom G6 CGM transmitters and sensors via Bluetooth. Live transmitter samples were considered real-time readings; backfill samples were excluded from real-time classification. Software synchronized with study servers after each sample acquisition, pending network connectivity. Descriptive statistics were evaluated for this pilot study.
Results: CGM readings (n=5,996) were generated over a 24 day study period. Median inter-sample interval was 5.0 minutes, and 99.4% of all sample intervals were between 4.9 and 5.1 minutes. Sample validity was high (98.6%), where 1.3% of samples were lost to sensor warmup and 0.05% of samples were lost to sensor error. Real-time measurements made up 96.4% of readings. Median transmitter sync time was 0.50 seconds (IQR: 0.26 - 0.75 seconds). Server upload times were fastest at 12 seconds; median upload time was 10.3 minutes (IQR: 5.3 - 25.3 minutes). Participant showed normal glycemic variability (19.7%), time-in-range (97.3%), and glycemic risk index (3.6%), with few Level-1 (n=3) and Level-2 (n=1) hypoglycemic events.
Conclusions: We developed a fully GxP-compliant high-speed data platform directly integrated with CGM devices. There is potential for low latency data availability - on the order of seconds - and further investigation is required to understand sources of server upload lag, for example network connectivity. Future development of this platform will include integrated hypo forms triggered by CGM data streams. Further work is needed to understand network dynamics of this framework in a larger study cohort.
D. Anderson: Employee; Clinical ink. M. Merickel: None. A. Best: Employee; Clinical Ink. B.T. Severson: Employee; Clinical Ink. C.B. Djurhuus: Stock/Shareholder; Novo Nordisk A/S. J. Goldman: Employee; Clinical ink.
