FDA approves iPhone connectible Dexcom G7 glucose monitor

Dexcom G7 works with Apple devices

The FDA has approved Dexcom's G7 wearable for glucose monitoring for people with all types of diabetes, and the company expects it hit pharmacy shelves in 2023.

The wearable is now cleared in the US for people with all types of diabetes aged two and older. It has a mean absolute relative difference (MARD) of 8.2%, which makes the Dexcom G7 the most accurate continuous glucose monitoring (CGM) system approved by the FDA, according to the company.

It offers real-time connectivity for integrated insulin delivery systems and can connect to other wearables, such as the Apple Watch. The G7 can also integrate with some digital health apps.

Other features

The new all-in-one device is 60% smaller than previous models, making it more discreet and uses fewer components. The redesigned receiver is also smaller and has an easier-to-read display.

Like the previous G6 model, the G7 doesn't require fingersticks, scanning, or calibration. Instead, it sends glucose readings in real-time every five minutes to a compatible display device.

The new G7 is smaller and more discrete than previous models

The system features a predictive low alert that provides a 20-minute warning of potentially dangerous low glucose levels so users can act to avoid a hypoglycemic event. Users can also share information with loved ones and care teams.

Availability

Dexcom says it's the number one covered and most reimbursed CGM on the market, with a third of patients with commercial coverage paying $0 out-of-pocket and the majority paying less than $40 per month.

The company expects to start a US launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, Dexcom will have accessible cash payment options as the company transitions coverage availability for G7.

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8 Comments

avon b7

said about 1 year ago

This is the expected good news for diabetics as it is smaller and uses less components but no system can currently eliminate pin picks completely, only reduce them.

That's good but any 'strange' readings must be checked via a traditional glucose monitor.

The Holy Grail is non-invasive continuous glucose monitoring and that is close to coming to market and will be a game changer even if precision isn't as good in early generation products.

All in all it is good news for diabetics especially if they qualify for low cost options on the G7 but the big news is yet to arrive.

zanoii

said about 1 year ago

While these solutions are great, the problem with these devices is that the glue that attaches them to the body is considered corporate secrets and is not examined by the FDA or similar authorities. This has lead to widespread skin hypersensitivity and rashes among users.

The adhesive must become part of the FDA approval process.

paxman

said about 1 year ago

I am a broken record on this subject. CGM's are very expensive but are covered by insurance for the lucky ones. Self financing is prohibitive for most people. Additionally CGM manufacturers greatly limit what end users can and cannot do with the devices making hacked solutions difficult. My plan (feel free to contact me for more brilliant advice, Apple :wink: ), is that Apple disrupt this market by buying one of the CGM companies, or manufacturing their own CGM's and then sell CGM's at cost so that virtually everyone can afford them. Apple should optionally bypass the iPhone and feed CGM data directly to the AW for live glucose readings. For deeper analysis and stats an iPhone or iPad would be required where it could all be integrated with Apple Health. There are approx 40 million Type 2 diabetics in the US alone, and god knows how many world wide. If CGM's were sold at cost (super cheap), all one would need is an AW and iPhone. Hell, instead of insurance companies financing CGM's for people they could finance AWs and iPhones. Sounds like a win win all-around, to me :)

Apple_Bar

said about 1 year ago

paxman said:

I am a broken record on this subject. CGM's are very expensive but are covered by insurance for the lucky ones. Self financing is prohibitive for most people. Additionally CGM manufacturers greatly limit what end users can and cannot do with the devices making hacked solutions difficult. My plan (feel free to contact me for more brilliant advice, Apple :wink: ), is that Apple disrupt this market by buying one of the CGM companies, or manufacturing their own CGM's and then sell CGM's at cost so that virtually everyone can afford them. Apple should optionally bypass the iPhone and feed CGM data directly to the AW for live glucose readings. For deeper analysis and stats an iPhone or iPad would be required where it could all be integrated with Apple Health. There are approx 40 million Type 2 diabetics in the US alone, and god knows how many world wide. If CGM's were sold at cost (super cheap), all one would need is an AW and iPhone. Hell, instead of insurance companies financing CGM's for people they could finance AWs and iPhones. Sounds like a win win all-around, to me :)

You want to side load on the CGM as well :D. You forgot to add to your dream requests that Apple should also forget about the FDA since the approval for the devices takes ages and also de for the apps which have to be FDA cleared as well.

Regarding the insurance comment: If you are in the position that your insurance doesn’t cover it at all. You have the option to shop around and get an insurance that will cover it because it is that important if you are a diabetic. I went from an insurance that didn’t cover it at all to an insurance that only cover it as a DME to now an insurance that I’ll just pick the items at a Pharmacy.

13485

said about 1 year ago

zanoii said:

While these solutions are great, the problem with these devices is that the glue that attaches them to the body is considered corporate secrets and is not examined by the FDA or similar authorities. This has lead to widespread skin hypersensitivity and rashes among users.

The adhesive must become part of the FDA approval process.

Pectin, made from apples, is a useful FDA-approved adhesive. On external devices, such as ostomy pouches for instance, it can adhere to the skin for several days with minimal or no issues. Skin contacting adhesives are absolutely examined by FDA if it is part of a medical device. Pectin may not be suitable in its entirety for this device, as I'm not sure of the duration of contact needed, but for other things it works well. Hydrogels are also designed for fairly long term skin contact, even for fragile skin, such as on those EKG electrode patches that they stick all over patients. Furthermore, there are a bunch of companies that will be happy to sell a device maker a suitable adhesive at any time. It's cheaper to buy a suitable product than invent it yourself. Been there.