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"FDA Innovation Pathways, iCGM, etc." - Courtney Lias of FDA at #DData18


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Courtney Lias of FDA talks about the new iCGM classification and diabetes innovation pathways at the DiabetesMine D-Data ExChange event on June 22 in Orlando.

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"FDA Innovation Pathways, iCGM, etc." - Courtney Lias of FDA at #DData18

  1. 1. FDA Innovation Pathways: iCGMs, etc. Courtney H. Lias, Ph.D. Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Food and Drug Administration D-data exChange June 22, 2018
  2. 2. 2 D-Data exChange June 2016
  3. 3. 3 Business as Usual = = = FDA Approval FDA Approval FDA Approval AID Controller PumpiCGM AID Controller PumpiCGM AID Controller PumpiCGM
  4. 4. 4 CGM modification 1 CGM modification 1 CGM modification 2 Time AID System 1 AID System 2 Business as Usual
  5. 5. 5 Goal: Greater Interchangeability AP Algorithm 2 AID PumpiCGM PumpiCGM PumpiCGM • More efficient regulatory pathways • Faster innovation • A more vibrant device ecosystem
  6. 6. 6 iCGM de novo
  7. 7. 7 New iCGM Regulation
  8. 8. 8 Performance Standard •Adult data must meet a specific performance standard •Pediatric data must be reasonably similar to adult data. Robust clinical iCGM accuracy data must be obtained from a clinical study
  9. 9. 9 Performance Standard Glucose Range 95% Lower Bound of the Confidence Interval of the % Within 15mg/dL/15%† 95% Lower Bound of the Confidence Interval of the % Within 40mg/dL/40%† <70 mg/dL > 85% > 98% 70-180 mg/dL > 70% > 99% >180 mg/dL > 80% > 99% †The absolute differences in mg/dL of values compared to the of the comparator method are calculated for all values below 70 mg/dL. For all values 70 mg/dL and above, percentage differences compared to the comparator method are calculated. • 95% Lower Bound of the Confidence Interval of the % Within 20mg/dL/20% must be > 87% • When blood glucose is <70 mg/dL, no iCGM values above 180 mg/dL • When blood glucose is >180 mg/dL, no iCGM values <70 mg/dL
  10. 10. 10 Variability and Sample Size will Affect Confidence Interval Estimates Why the lower bound? Performance goal
  11. 11. 11 Performance Standard iCGM Rate Range (mg/dL/min) Comparator Rate Range (mg/dL/min) <-2 [-2,-1) [-1,-0) [0,1] (1,2] >2 <-2 [-2,-1) [-1,0) [0,1] (1,2] >2 The most dangerous trend errors must be significantly limited <1% <1%
  12. 12. 12 iCGM Communication Protocols A detailed strategy to ensure secure and reliable means of iCGM data transmission to digitally connected devices must be submitted. • How will communication protocols be provided • Proprietary protocol • Published protocol • Open protocol • Open standard • Any relevant risk mitigations • Describe how complaints/problems will be handled with another system is involved
  13. 13. 13 Continued Performance Controls • Must describe manufacturing release testing protocols and acceptance criteria • No interferences that pose unmitigated clinical risk. • The iCGM must include appropriate measures to ensure that disposable sensors cannot be used beyond the claimed sensor wear period.
  14. 14. 14 Transparency iCGM labeling must describe sensor performance: • Accuracy in specific blood glucose concentration ranges: • Accuracy of positive and negative rate of change data. • Frequency and duration of gaps in sensor data. • True, false, missed, and correct alert rates* • Observed duration of iCGM life for the device. • True Notification Rate - the % of time the device alarmed when the blood glucose level exceeded the alert setting • False Notification Rate - the % of time the device alarmed when the blood glucose level did not exceed the alert setting • Correct Detection Rate - the % of time the device alarmed when the blood glucose level exceeded the alert setting • Missed Detection Rate - the % of time the device did not alarm when the blood glucose level exceeded the alert setting * <54 mg/dL 54-69 mg/dL 70-180 mg/dL 181-250 mg/dL >250 mg/dL
  15. 15. 15 To market an iCGM a sponsor must: • Demonstrate accuracy and reliability in the hands of the intended user (performance standard) • Provide an acceptable communication process that includes a process to communicate postmarket issues • Have adequate methods to assure that the iCGM maintains performance across devices and lots • Make the performance of the device transparent by including certain specific descriptive information in the labeling • Factory calibration is not required • iCGM clearance does not mandate a sponsor must agree to connect with any other device, though it also does allow it
  16. 16. 16 AID Controller PumpCGM How does this change things? AID Controller PumpCGM System approved with this CGM New PMA New clinical data AID Controller PumpiCGM AID Controller PumpiCGM System approved for any iCGM Cleared iCGM No submission Approved process Labeling Update
  17. 17. 17 • Makes iCGM upgrades/modification availability more efficient • Reduces the need for duplicative regulatory submissions • Separates the iCGM from the AID (or other compatible device) system • Allows connected systems to be updated more quickly and with a predictable process • Works for many different business models (from open to closed systems) • Should allow more opportunity for patient choice • Regulatory advantages may incentivize additional technology development for accuracy and reliability
  18. 18. 18
  19. 19. 19 Software that provides insulin therapy adjustment recommendations to physicians to aid in the management of patients with Type 1 diabetes who use an insulin pump and a CGM • Provides recommendations for adjustments: • basal insulin delivery rate(s) • insulin to carbohydrate ratio • correction factor (insulin sensitivity) Results are sent to physicians who can approve, reject or change the recommendations and issue the updated treatment plan to the patient. DreaMed Advisor Pro
  20. 20. 20 De Novo granted June 12, 2018 Insulin Therapy Adjustment Device (21 CFR 862.1358, class II): An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus. Special controls include: • Describe algorithm and data inputs (including timeframe and number of data points required) • Describe outputs and insulin therapy adjustment recommendations, including how the recommendations are generated. • Demonstrating clinical validity, and appropriate measures to mitigate and minimize dosing errors • Describe input data specifications, including accuracy requirements for CGM data • Describe data communication plan • Human factors • Transparent labeling DreaMed Advisor Pro
  21. 21. 21 Thursday, June 21, 2018: MiniMed 670G HCL System approved for use in 7-13 yo children MiniMed 670G
  22. 22. 22 June 21, 2018: Senseonics Eversense CGM Approved Senseonics Eversense
  23. 23. 23 June 21, 2018: t:slim X2 Insulin Pump with Basal IQ Technology Approved Tandem PLGS Basal IQ Technology incorporates predictive low glucose suspend software into the t:slim pump platform Approved for use with: • Dexcom G5 CGM • Any iCGM