Memorandum

iHealth launches Bluetooth-connected Smart-Gluco Monitoring System; meter wirelessly sends results to Apple iOS devices – October 30, 2013

Executive Highlights

  • iHealth Lab has launched its wireless Smart Gluco Monitoring System. The product includes a standalone meter that wirelessly sends results (via Bluetooth) to an accompanying iPhone/iPad/iPod touch app.
  • The meter plus 50 strips are retailing for $79.95 on iHealth’s website, BestBuy.com, and in select Best Buy retail stores nationwide.

Today, Mountain View, CA-based iHealth Lab announced the launch of its wireless Smart Gluco-Monitoring system in the US (cleared by the FDA on April 12, 2013). Similar in principle to LifeScan’s OneTouch VerioSync (cleared by the FDA on Feburary 7, but still not launched; read our original report), iHealth’s Smart-Gluco Monitoring System features a standalone meter that wirelessly sends results (via Bluetooth) to an accompanying iPhone/iPad/iPod touch app. The meter plus 50 strips are retailing for $79.95 on iHealth’s website. Notably, the device is also available on BestBuy.com and will be available in select Best Buy retail stores nationwide (“as part of the retail chain's effort to be the leading retailer of health and wellness technologies” – news to us!). The meter will also soon be available at a “leading national drug retail chain” – we assume Walgreens or CVS. The meter is not covered by insurance at this time – it’s unclear if the strips are covered by insurance, but we are following up with the company.

The accompanying iHealth Gluco-Smart app is free and currently available on the iTunes store. We downloaded the app and set up an account quite quickly. It does not seem as sleek as Sanofi’s iBGStar app, though we have not fully tested it with the new meter to say for certain.

The meter itself is quite futuristic-looking, about the size of two strip vials (3.8’’× 1.35’’× 0.75’’), has an LED display, and is rechargeable via USB (200 tests on a single charge). Its FAQ page notes that it meets the recently updated ISO 2013 requirements, which are more stringent than the 2003 requirements (see below). The iHealth-brand strips require a 0.7 micro-liter sample (larger than the industry-leading 0.3 microliter sample) and results are displayed in five seconds. Following initial setup, the meter can be used with or without a nearby Apple device. Up to 500 offline measurements can be stored in the meter. In addition to syncing with the app, results are also stored in the cloud on http://www.ihealthlabs.com. The device also has a novel feature to keep track of strip usage and code the meter – a QR code must be scanned with the app each time a new strip vial is opened. While it’s a downside that the strips require coding, it’s a plus that the company has made this easier than manual entry.

We see the approval and launch of this device as a good sign for patients (easier data collection and transmission), providers (easier access to blood glucose data), and a continuation of an industry trend towards smartphone/cloud-connected meters – below is a non-exhaustive list of those we are aware of (we acknowledge there are certainly many more). We believe the entire glucose monitoring industry is moving in this direction, and it will only be a matter of time before nearly all meters are cloud connected.

  • The iHealth Smart-Gluco Monitoring System was cleared by the FDA on April 12, 2013, reflecting slightly less than a four-month 510(k) application review. By comparison, the OneTouch VerioSync’s FDA review was 11 months. We continue to wait for the launch of the Verio Sync, which was cleared two months before iHealth’s product – in the ADA 2013 exhibit hall, we heard that it was launching “very soon.”  
  • iHealth has a suite of other health devices that connect to mobile apps: wireless blood pressure monitors, wireless scales, an activity and sleep tracker, and a wireless pulse oximeter. It’s great to see this holistic approach to health data collection, and we expect to see the new glucose meter interface with these other devices through the iHealth app(s).

Company/Product

Description

Status

Closer Look / diaTribe coverage

iHealth Smart Gluco-Monitoring System

Standalone meter; wireless Bluetooth sync to app on Apple devices

Launched in US on October 30, 2013; CE Marked

Enclosed

LabStyle Innovations Dario

All-in-one meter, lancing device, strips; meter plugs into headphone jack of iPhone and Android

Soft EU launch in late 2013

http://www.closeconcerns.com/knowledgebase/r/cf60b68c

Sanofi iBGStar

Standalone meter; plugs into iPhone charging port (iPhone 5 only with lightning adapter)

Available in US and EU

http://www.closeconcerns.com/knowledgebase/r/afddbe77
http://diatribe.org/issues/43/test-drive

J&J LifeScan OneTouch VerioSync

Standalone meter; wireless Bluetooth sync to iPhone app

FDA approved in February 2013; demo in ADA 2013 exhibit hall; launching “very soon”

http://www.closeconcerns.com/knowledgebase/r/164d9ab5
http://www.closeconcerns.com/knowledgebase/r/4f5547c3

Telcare

Cellular-enabled standalone blood glucose meter

Available in US

http://www.closeconcerns.com/knowledgebase/r/8b209452

http://diatribe.org/issues/41/test-drive

Ambio Remote Health Monitoring System

Wireless-enabled AgaMatrix Presto glucose meter

FDA 510(k) clearance on July 30

http://www.closeconcerns.com/knowledgebase/r/cc22e813

YOFi Meter

All-in-one meter, lancing device, strips; cellular chip; color touchscreen; built-in pedometer

On the market “next September” (unclear if US, EU, or both)

http://www.closeconcerns.com/knowledgebase/r/3623657f

VPD 2in1 Smart/ Philosys Gmate Smart

Meter plugs into headphone jack of iPhone and Android

CE Mark, available in 12 EU countries; under FDA review

http://www.closeconcerns.com/knowledgebase/r/3623657f

  • Updated ISO 2013 standards: 95% of measured glucose values must fall within 15 mg/dl of reference for values <100 mg/dl or within 15% for values >100 mg/dl. ISO has also added a new stipulation to tighten down on outliers: 99% of glucose values must fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes. The new published standard recommends a 36-month transition preceding “mandatory compliance” with the updated tighter requirements.
    • While the FDA chose to adopt the 2003 ISO 15197 standards, it is not legally required to adopt the revised 2013 ISO requirements. There have been indications at recent conferences that new FDA BGM requirements are coming – we hope to see them soon. 
    • The new ISO guidelines tighten the 2003 standards in two key ways. First, the older standard had less strict cutoffs for accuracy: 95% within ±15 mg/dl and ± 20% (looser than the new ±15%) at a threshold of <75 mg/dl and >75 mg/dl, respectively (looser than the new 100 mg/dl). Second, the 2003 ISO standard did not put any limits on the 5% of results that did not meet the specified criteria. The update now tightens down on outliers, mandating that 99% of values must also fall within zones A and B of the CEG (specifics below).

Close Concerns Questions

Q: Are the iHealth strips manufactured by another company and rebranded? Or are they proprietary iHealth strips?

Q: What is the device’s specific strip accuracy data at margins of 15 %/15 mg/dl and 10%/10 mg/dl

Q: What is currently the reimbursement situation for the strips?

Q: How will the iHealth glucose meter interface with the other devices/apps in the iHealth portfolio?

--by Adam Brown and Kelly Close