Standard Operating Procedure for Medtronic continuous glucose monitor
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1 Standard Operating Procedure for Medtronic continuous glucose monitor Effective date: Review due date: Original Author Name: Richard Metcalfe Position: PhD Student Date: Reviewer Name: Pippa Heath Signature: Approved by Name: Dr Lisa Austin Position: Physiology Technician Date: Position: DfH Research Manager Date: Signature: Amendment Chronology Version Effective Reason for amendment Reviewed/Amended by number date First issue Richard Metcalfe No amends, review only Ben Lee Reviewed, updated RA link Pippa Heath
2 Medtronic Continuous Glucose Monitor Safety Information: Ensure that you have had appropriate training and have read the relevant operator s manual/s and any specific documentation prior to using the equipment or undertaking the following task. Prior to using the CGMS you should refer to the risk assessment: o RA_cgms Equipment (for insertion): Gloves Medtronic lancing device Glucose sensor (to be stored in the fridge) Glucose monitor (kept on charger) Alexander magnetic wand Freestyle lite finger prick glucose monitor Steret alcohol wipe Sharps bin Autoclave bag Blue Roll 2 x IV Hand Cannula Dressing Computer with Medtronic Solutions CGMS ipro glucose monitoring software Abbott wire-usb to Serial Plug USB to serial connection wire with ipro receiver attached. Method: 1. Talk participant through procedure and check informed consent has been provided. 2. Discuss the positioning of the monitor with the participant to ensure it will not interfere with daily activities/sports. As a guide this should be above the waistband approximately level with the belly button, slightly to one side (5-10cm). N.b if the participant has undergone an adipose biopsy on the same day always insert the monitor on the opposite side that this was carried out. 3. Remove sensor from fridge (this should be left for 10 minutes at room temperature prior to use). 4. Load lancing device with indwelling sensor. Retract central white section until it clicks. 5. Remove top layer of clear plastic from around the needle on the sensor to expose sticky surface.
3 6. Remove plastic safety sleeve from the needle. 7. Clean target area with alcohol wipes. 8. Ask participant to pull skin upwards from above where the sensor is to be inserted so that skin is taut. 9. Place lancing device firmly against skin at an angle of 45 degrees. (N.b In particularly lean individuals where there is little abdominal fat this angle needs to be reduced to ~30 degrees) 10. Press white button on end of the lancing device to fire the sensor into the skin. 11. While holding the sensor stable with one hand, pull the lancing device away from the sensor. 12. Remove the needle slowly at the same angle as it was inserted and dispose of in sharps bin. 13. Pull the white tab on the end of the sensor away from the belly button, to expose the attached adhesive patch, place down on participants skin to secure the sensor. Get participant to sit or lie down after the securing the sensor. 14. Before attaching the monitor to the glucose sensor it must be in situ for 5 minutes, during this period complete steps Check computer is set to American time, if not change it to this setting via the regional and language options in the control panel. 16. Establish which comm ports the Stereo plug and ipro receiver are attached to. This is done by right clicking on my computer>selecting manage>then device manager>then ports. Note these down. 17. Open software named Solutions CGMS ipro. 18. Click on Start New under New Patient Setup. 19. Double check the time and date displayed are correct for American time then select next. 20. Select FreeStyle meter from the options, select the comm port for the Abbott Stereo plug, then attach the meter to this wire and click next. (The programme will ask if the time is correct for the meter, if it is not then this can be adjusted by holding down the the m button on the meter until SET is shown on the screen. To scroll to the next part of the time or date settings hit m, to adjust the selected value on the screen up hit c). 21. Enter the glucose monitor serial number on the back of the monitor as shown by the diagram, then click next. 22. Select the appropriate comm port for the ipro receiver. 23. Attach the monitor to the sensor. When done correctly there will be an audible click. With a successful attachment the monitors yellow light will also begin to flash,
4 when this occurs click on next and ask the participant to stand as close as possible to the ipro receiver. 24. The ipro receiver will then check the monitor, once this has been successfully located, click on next. 25. Take the Alexander magnetic wand and place the magnetic end on the curved edge of the monitor and slide slowly around the edge for a minimum of 5 seconds, and then click next. 26. There should be a message to say that the monitor has been successfully installed. 27. Tape the monitor down using Micropore in an x shape so that the tape is across both the sensor and monitor. Place two of the cannula dressings on top of the sensor by firstly removing the orange backing and then placing it on the skin around the sensor, and then pulling the clear thick backing off to leave a thin clear plastic covering on the sensor. Place the second dressing above the first to create a seal so that water will not get under the dressing with showering. 28. Show participant how to take a fingerprick blood sample using the freestyle meter. (During wearing of the continuous glucose monitor these samples must be taken 4 times a day ((upon waking, before lunch, before dinner and immediately prior to sleep)) so the monitor can be calibrated). The participant needs to take the first fingerprick test 1 hour after insertion. 29. Check participant is feeling ok and then send away with Freestyle glucose meter and spare cannula dressings if they want to change the dressings following showering etc Equipment (for removal): Gloves Autoclave bag Steret Plaster Tissues 1. Explain procedure to participant. 2. Get participant to sit or lie down. 3. Remove adhesive dressings from monitor. 4. Remove monitor from sensor by holding edges of the sensor firmly and then pulling the monitor away from the belly button. Once removed clean monitor of any excess glue using steret. 5. Pull sensor slowly out of participant and dispose of in autoclave bag. 6. If there is any bleeding, apply pressure to area with a folded up tissue. 7. Clean area around sensor of any dried on blood/dirt with steret.
5 8. Place plaster where puncture hole for sensor was. 9. Check participant is ok and then send away. Equipment (for reading): Medtronic glucose monitor tester device Computer with Medtronic Solutions CGMS ipro glucose monitoring software Abbott wire-usb to Serial Plug USB to serial connection wire with ipro receiver attached. Alexander magnetic wand Freestyle lite finger prick glucose monitor 1. Open Solutions CGMS ipro software. 2. Click on Patient data from CGMS ipro and meter under download device data. 3. Enter an appropriate file name in patient ID, participant name and the experimenters name as physician. Do not adjust the target glucose range or pre-set time blocks. Click next. 4. Select the appropriate comm port for the CGMS ipro receiver and then click next. 5. Enter as instructed the monitor serial no. which is found on the flat side of the monitor. 6. Attach the monitor to the tester, when it flashes, slowly slide the Alexander magnetic wand around the curved edge of the monitor and click ok. 7. Once successfully downloaded, select the Freestyle meter from the options on screen and attach the Freestyle Lite to the Abbott Stereo plug. Select the appropriate comm port and then select download. 8. Select yes to saving the data before adding event markers. 9. Once this is completed the data will have been formed into a file and saved in the C drive, remember to save as and move the file to an appropriate location on a centrally backed up \\x:drive. 10. If you want to look at your data, select the icon with multi-coloured graphs, this will allow you to view your traces. End of Document
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