Aspire
Damiano
Accuracy Matters and Accuracy you can Trust
530G Owner's Guide
MDT SSED
100
11.9 Minutes
What is the average suspend time during the Aspire trial?
100
10.8% and 18.2%
What is MARD for Dexcom and Medtronic during the Damiano Study?
100
13.3%
What is the MARD for the G4 Platinum?
100
Page 11
What is page number that the exact same Tylenol/Acetaminophen verbage appears in the 530 G owner's manual.
100
60mg/dl - 90mg/dl
What is the range that the glucose threshold can be set at on the Threshold Suspend feature? Page 4
200
4.8 days
What is the average sensor life in each arm of the Aspire Study? (Second arm used enlite but no LGS)
200
23 Type 1
What is number of Type 1 patients that wore all three devices during the Damiano Study?
200
16.7%
What is the MARD for the MDT Enlite?
200
Double Jeopardy- May bet up to 1000 Points (200pt increments) ------------------------------------------------------------------ A feature that "cannot be used to prevent or treat hypoglycemia"
What is the Threshold Suspend Feature? Page 208 (also referenced at least 6 other places in the manual)
200
3, 6, 12 and 24
What is the choice the patient has to view the glucose history on the graphical display on the 530G? Page 5
300
31.8%
What is the amount of reduction in nocturnal hypoglycemia in the LGS arm of the Aspire Study?
300
2360
What is number of paired data points during the Damiano Study?
300
83%
What is the hypoglycemia accuracy for the G4 Platinum? (within 20mg/dl in 40-80 mg/dl)
300
2 hours, 6hours, 12 hours
What is the times that you have to calibrate your Medtronic 530 G when you start a new sensor.
300
61.7%- 79.2%
What is hypoglycemia accuracy for MDT with in 20mg/dl in the 40-80mg/dl range over the course of 6 days. Page 37
400
ZERO/ No Improvement (From the post study Survey with LGS vs. Control
What is the difference in the Quality of Life?
400
Accuracy
What is primary end point of the study?
400
51.5%
What is the false alert rate for the MDT Enlite at 70mg/dl?
400
Double Jeopardy- May bet up to 2000 Points (400pt increments) ------------------------------------------------------------------ 12 inches
What is how far you are recomended to keep your cell phone away from your pump in order to reduce "communication problems"? Page 18
400
64.3%
What is % of False alerts with the CGM Alert set at 60 mg/dl using 15 min +/-, with both Threshold and Predictive alerts turned on and Calibrating 3-4 times a day with an abdomen insertion site? (YSI compared to CGM) Page 41
500
The amount of food or gulcose ingested during the Aspire Study
What is Completely Unknown?
500
"G4 was markedly more accurate than Enlite"
What is a direct quote from Dr. Damiano Study that was presented at the ADA in 2013 regarding his Bionic Pancreas Project?
500
94%
What is the percent of G4 Platinum sensors that last 7 days?
500
Are three examples of differences between this 530g and the previous system.
What are now only indicated for 16 and older, only to be inserted in the abd, recomending 3-4 calibrations a day. page 11 & 145
500
73.1%
What is % of False alerts with the CGM Alert set at 60 mg/dl using 15 min +/-, with both Threshold and Predictive alerts turned on and Calibrating every 12 hours with an abdomen insertion site? (YSI compared to CGM) Same source as our 51.5% data just looking at 60mg/dl instead of 70mg/dl Page 42
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