How Glucose Sensors Check Their Own Reliability for Insulin Pumps
This patent describes a system that automatically checks how trustworthy a continuous glucose sensor's readings are and then adjusts how an insulin pump delivers medicine based on that trust level.
Patent Number
US 9282925
Status
Active
Filing Date
March 25, 2010
Grant Date
March 15, 2016
Expiration
March 25, 2030
Claims
25
Assignee
Dexcom
Inventors
Aarthi Mahlingam, Apurv Ullas Kamath, James H. Brauker
Citations
10 forward · 718 backward
What it covers
The patent details a system (Claim 14) and method (Claim 1) for a continuous glucose sensor (CGS) to assess its own data quality. An "electronics unit" receives glucose data from the CGS. A "signal reliability module" on a processor then determines a "level of reliability" for that data. This reliability level is chosen from at least three pre-set options, stored in memory (Claim 1). For example, if the sensor detects "transient non-glucose related signal artifacts" (Claim 8) or a "drift in sensitivity" (Claim 3), it might lower its reliability score. Crucially, this reliability score is then used to "control the administration of a medicament" (Claim 1), such as adjusting insulin delivery from an insulin pump. The system can also prompt a user for a reference glucose value if reliability is low (Claim 13).
What it doesn't cover
- —Does not cover systems that only detect noise without using a "level of reliability" selected from "three or more predetermined reliability levels" (Claim 1).
- —Does not cover systems where the reliability assessment does not directly "control the administration of a medicament" (Claim 1).
- —Does not cover systems that only filter noise from glucose data without using the reliability level to influence medicament delivery.
- —Does not cover systems where the reliability is determined by only one or two levels, as "three or more predetermined reliability levels" are specified (Claim 1).
- —Does not cover systems that only display reliability to a user without also controlling medicament administration.
The clever bit
The novelty lies in not just detecting signal issues, but in assigning a specific, multi-level "reliability score" to the sensor data and then directly using that score to control medicament administration. This moves beyond simple error flags to a more nuanced, automated decision-making process for drug delivery.
Why it matters
This patent is significant for the development of "closed-loop" or artificial pancreas systems for diabetes management. By enabling a continuous glucose monitor (CGM) to assess its own data quality and automatically adjust insulin delivery, it helps make these systems safer and more effective. It addresses the critical challenge of ensuring reliable sensor data for automated drug delivery.
Real-world examples
- 1.Automated insulin delivery systems
- 2.Artificial pancreas systems
- 3.Dexcom G6/G7 continuous glucose monitoring systems
- 4.Medtronic MiniMed 780G insulin pump system
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