{"id":48773,"date":"2018-03-31T11:01:07","date_gmt":"2018-03-31T15:01:07","guid":{"rendered":"https:\/\/asweetlife.org\/?p=48773"},"modified":"2018-03-31T11:01:07","modified_gmt":"2018-03-31T15:01:07","slug":"first-look-at-dexcoms-g6-cgm","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=48773","title":{"rendered":"First Look at Dexcom&#8217;s G6 CGM"},"content":{"rendered":"<p>Thirty-one years ago, I was checking my blood sugar with\u00a0<a href=\"http:\/\/sixuntilme.com\/2009\/11\/diabetes_torture_devices.html\">this giant lancing device<\/a>, using a heavy brick of a glucose meter, and chasing my blood sugars with Regular and NPH insulin. \u00a0If you told me that the future of diabetes would include streaming video of where my blood sugars have been and where they might be headed, I\u2019d have bonked you on the nose with a newspaper. \u00a0\u201cNo. \u00a0NO! \u00a0Bad dog. \u00a0Don\u2019t make false promises \u2013 they\u2019ve already told me a cure would be here in five years and I know that\u2019s bullshit.\u201d<\/p>\n<p>But oh hey, Dexcom G6. \u00a0Just <a href=\"https:\/\/asweetlife.org\/fda-approves-the-dexcom-g6-cgm-system-no-finger-sticks-necessary\/\">approved by the FDA<\/a> and slated to hit the market (and my body) sometime in the second half of the year (but potentially at the close of Q2), continuously monitoring my blood sugar just got easier.<\/p>\n<p>I know a lot of sites have already covered the Dexcom G6 approval (<a href=\"https:\/\/www.healthline.com\/diabetesmine\/newsflash-fda-oks-dexcom-g6-cgm#10\">this write up at DiabetesMine is very thorough<\/a>), but I wanted to give a few quick details and a look at the demo kit I received yesterday.<\/p>\n<p>Here are the new Dexcom bits and pieces that were sent over to me. \u00a0No, none of these pieces actually work as they are part of a marketing outreach plan, and\u00a0<strong>yes\u00a0<\/strong>I was disappointed as hell that I couldn\u2019t stick on the new G6 sensor as I am very excited to try it.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-48774 lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Quarter.jpg\" alt=\"Dexcom - Sensor and Inserter\" width=\"451\" height=\"500\" data-sizes=\"auto\" data-srcset=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Quarter.jpg 451w, https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Quarter-271x300.jpg 271w\" sizes=\"(max-width: 451px) 100vw, 451px\" \/><\/p>\n<p>This is the new insertion device \u2013 looks straight outta Wall-E \u2013 and the new transmitter and sensor. \u00a0The G6 transmitter is much thinner than the G5, by about a third.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-48775 lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Quarter2.jpg\" alt=\"Dexcom G6 Sensor\" width=\"500\" height=\"386\" data-sizes=\"auto\" data-srcset=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Quarter2.jpg 500w, https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Quarter2-300x232.jpg 300w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/><\/p>\n<p>Here is a visual only useful for Americans. \u00a0But this is the transmitter and sensor pitted against a quarter, for reference.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-48776 lazyload\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Sensor.jpg\" alt=\"Dexcom - G6 - Sensor\" width=\"500\" height=\"220\" data-sizes=\"auto\" data-srcset=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Sensor.jpg 500w, https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Sensor-300x132.jpg 300w, https:\/\/asweetlife.org\/wp-content\/uploads\/2018\/03\/Dexcom-G6-Sensor-340x150.jpg 340w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/><\/p>\n<p>And here is the transmitter and sensor all on their own. \u00a0It\u2019s very thin and it would have been great if I had a G5 transmitter to compare it to, but my current sensor is only on day 4 and there\u2019s no way I\u2019m ripping that thing of yet.<\/p>\n<p>Here\u2019s a quick look at the demo receiver (with an off-center thumbs up at the end):<\/p>\n<p>https:\/\/www.youtube.com\/watch?time_continue=3&#038;v=iDUFH4HzTNU<\/p>\n<p>First impressions on this new iteration of my CGM standard?<\/p>\n<ul>\n<li>YES the\u00a0<a href=\"https:\/\/www.dexcom.com\/faq\/what-are-main-differences-between-dexcom-g5-mobile-and-g6?category=2596\">Tylenol indication is gone<\/a>. \u00a0Now a headache can be treated without screwing up my Dexcom\u2019s sensor integrity.<\/li>\n<li>It\u2019s so much smaller than the G5. \u00a0I can\u2019t wait to wear this lower profile device.<\/li>\n<li>The insertion device looks way friendlier than the current G5 (and all the previous versions, way back to my first STS insertion device). \u00a0From what I\u2019ve heard, this insertion device comes with every single sensor. \u00a0Which I think is a huge waste of plastic, so I\u2019m hoping that\u00a0<a href=\"https:\/\/www.dexcom.com\/faq\/dexcom-creating-recycling-program-sensor-applicator-launch?category=2596\">a recycling program for this thing comes about<\/a>.<\/li>\n<li>There\u2019s a\u00a0<a href=\"https:\/\/www.dexcom.com\/faq\/can-sensor-be-restarted-after-10-days?category=2596\">hard stop at the 10 day mark<\/a>\u00a0for this sensor. \u00a0I currently restart my sensors, but haven\u2019t ever made it a full two rounds with one sensor as my skin hates most adhesives and only recently stopped having a blistering reaction to the Dexcom adhesive. \u00a0The inability to restart a sensor is a big deal for people paying out of pocket, among other reasons \u2014 more on that in a minute.<\/li>\n<\/ul>\n<p>I talked with Dexcom\u2019s CEO,\u00a0<a href=\"https:\/\/www.dexcom.com\/dexcom-leadership\/kevin-sayer\">Kevin Sayer<\/a>, about the new G6, and he was kind and patient as I took the call from a busy coffee shop. \u00a0(And if you have other questions,\u00a0<a href=\"https:\/\/www.dexcom.com\/faq\/g6\">there\u2019s a very good FAQ section on Dexcom\u2019s site that might have an answer or two for you<\/a>.)<\/p>\n<p>I asked him about factory calibration for the G6, and he said that the goal was to have the algorithm perform consistently on all days and all ranges, and that performance is very strong. \u00a0The accuracy is a experience similar to the 505 and across all ranges, it performs better on the first day than G5 did. \u00a0 (A nice note, as many Dexcom users have complained about poor response from their sensor on the first day.)<\/p>\n<p>And even though the G6 comes out of the box calibrated,\u00a0<a href=\"https:\/\/www.dexcom.com\/faq\/does-g6-accept-calibrations?category=2596\">patients can still calibrate their sensor<\/a>\u00a0if they think it\u2019s necessary. \u00a0\u201cIf a patient truly thinks the system needs to be calibrated, they can calibrate it. \u00a0Also, our pump partners may want the system calibrated. If a patient feels there is variation and they want to calibrate the system, they can,\u201d said Sayer.<\/p>\n<p>There\u2019s also a\u00a0<a href=\"https:\/\/www.dexcom.com\/faq\/are-there-any-changes-alarms-and-alerts?category=2596\">new alert in play for the G6 system<\/a>, one that alarms when a low is expected. \u00a0\u201cThe \u201cUrgent Low Soon\u201d alert is a new alert that can warn users in advance (within 20 minutes) of a severe hypoglycemic event (55 mg\/dL) \u2014 allowing them time to take appropriate action before an event happens.\u201d<\/p>\n<p>On the 10 day use period for the G6, it\u2019s confirmed that the sensor times out and can\u2019t be restarted. \u00a0\u201cAs we got our system approved under the special controls required by the FDA, the system cannot be used longer than it\u2019s approved duration,\u201d said Kevin Sayer. \u00a0Personally, this is a rough change, as many people with diabetes pay for their CGM supplies out of pocket, and a hard stop at 10 days would cut into a lot of budgets. \u00a0But he mentioned that a company goal is to extend the life of the sensor, and that they are working for approval for 14 day use, after they can meet the requirements set forth by the FDA. \u00a0There isn\u2019t a set timeline for a 14 day sensor, but Sayer was hopeful for 2019. \u00a0He also mentioned that Dexcom will be providing their own overtape to help keep the sensors in place for approved duration.<\/p>\n<p>The sensor size is much smaller, and Kevin says that another company goal is to continue to reduce the sensor size. \u00a0\u201cWhen I see kids running around with the sensor on, I look at them and say, \u2018This has got to be smaller.&#8217;\u201d \u00a0Agreed. \u00a0And the new G6 is smaller in hopes of reducing tugging and snagging on clothes, which will be useful in my house (see also: \u00a0my son uses my sensor as a rung with which to climb me)<\/p>\n<p>One of the big things about this approval is that Dexcom is moving to the FDA 510K class. The FDA has established standards as to how sensors have to perform to be approved.\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPMN\/pmn.cfm\">The FDA website defines a 510K class device as<\/a>\u00a0\u201cA 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR \u00a7807.92(a)(3)) that is not subject to premarket approval.\u201d \u00a0Basically, approvals should be able to roll out in a more expedited fashion as a result. \u00a0Which is exciting. \u00a0Full docs from the FDA on that process\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf17\/DEN170088.pdf\">can be found here<\/a>.<\/p>\n<p>Technology keeps getting better. \u00a0It\u2019s an exciting time to be a CGM user. \u00a0But as I write this, I\u2019m reminded that this technology is only great for people who can access it, and that folks in our community still struggle to access insulin every day. \u00a0Which is why I\u2019m closing with a request for you to consider\u00a0<a href=\"https:\/\/lifeforachild.org\/you-can-help\/donate.html\">donating to the International Diabetes Federation\u2019s Life for a Child program<\/a>, and\/or to explore participating in the\u00a0<a href=\"https:\/\/www.t1international.com\/usainsulin4allaction\/\">T1International #insulin4life efforts<\/a>. \u00a0Access matters, and even the best devices are useless if we are without insulin.<\/p>\n<p>Let\u2019s all move forward, making sure we take care of our community as a whole along the way.<\/p>\n<p>Originally published on <a href=\"http:\/\/sixuntilme.com\/wp\/\">Six Until Me<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&hellip;<\/p>\n","protected":false},"author":62,"featured_media":48751,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"image","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1437],"tags":[115],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>First Look at Dexcom&#039;s G6 CGM<\/title>\n<meta name=\"description\" content=\"The Dexcom G6 CGM was just approved by the FDA and slated to hit the market (and my body) sometime in the second half of the year. 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