Dr. Stephen Ponder, who has Type 1 diabetes himself, has been a pediatric endocrinologist for 20 years. He is director of the Children’s Diabetes and Endocrine Center of South Texas at Driscoll Children’s Hospital. He’s also been working with a company called Diabetech on a diabetes monitoring device called GlucoMON for the past several years. Today, he has some big news to report.
But first, for those who are unfamiliar: GlucoMON is “a small, portable wireless appliance that makes it easy to collect and share blood glucose readings.” You don’t need an internet connection, or even a computer or a 
phone line to use it. Data is transferred over a proprietary network and stored in the company’s own secure patient record system. Expert D-writer David Mendosa has posted rave reviews of GlucoMON. Here’s also a video illustrating how it works for families with Type 1 children.
To be honest, the company’s been a bit annoyed with me that I haven’t written more about GlucoMON and the related Diabetes HouseCall program over the past few years. Somehow, it didn’t seem to capture my attention. But this new note from Dr. Ponder definitely did:
Amy,
I’m writing to let you know that several years of dedication and hard work has just paid off BIG. I just completed a year-long randomized controlled clinical trial of the GlucoMON device applied to a large cohort of pre-adolescent type 1 children here. You have perhaps been following the evolution of this technology over the past 7 years.
Well, this study showed significant improvements in A1C with (by clinical design) no additional intervention whatsoever from the diabetes provider or team! Daily BG monitoring frequency was sustained and at very high levels above norms. I knew you would appreciate these data. Overall, we saw a full point drop in mean A1C for patients with A1C > 8% at entry. Incredible! You know what that means if leveraged across over a population! If the same effect were accomplished with a pharmaceutical agent, it would become a billion dollar drug! Better yet, no adverse side effects to worry about down the road! Think about risk reduction over time as well! I know a 1 point A1C increase raises complication risk ~10%.
I need to explore if the reverse holds true. By actuarial analysis, if these data were to be leveraged across a large health plan population, cost savings would be huge! Also, the electronic format used to capture the data also flows effortlessly into the concept of Health Information Exchanges, which seem to be on their way soon. {PHR systems?}
Our data even appears to be better than those reported in New England Journal of Medicine with Continuous Glucose Monitoring technology (expensive, time and labor-intensive so far) in regards to change in A1C for this age population (they reported NO mean change).
The reason for our success seems to be related to several factors, including 1) the Day over Day BG plot format (simple) and 2) how it’s automatically forwarded to the patient/family by our ADMS system (elegant). The patient does not have to possess any technological skill, special knowledge, or equipment for this to work. In fact several families had no PC or internet access whatsoever. It works in rural and urban settings equally well. The background support is seamless and the patient does nothing extra (i.e., simple for patient to use). The GlucoMON device itself is only part of the solution. It’s the other systems quietly running in the background that drive the success as I see it. But best of all, I and my staff had to do nothing to obtain this benefit to our patients!
When you consider that we’ve all been searching for straightforward ways to 1) improve diabetes care for patients of all ages (and this device has been used with adults with type 1 and 2 with similar success), plus 2) hold down costs of diabetes and its complications, and 3) save time and burden to the health care provider, all while 4) encouraging positive self care behaviors in the patient, this meets and exceeds ALL those expectations and we have proof now from a year long randomized/controlled trial!
We now have Blue Cross Blue Shield of Texas and our local Medicaid managed care provider on board covering GlucoMON as a member benefit (as well as the Diabetes Housecall program, an innovative at home-based visual telemedicine program I created 4 years ago). There are even more powerful tools this technology can leverage that were never even activated for this year-long study. One of my next steps is to conduct a multi-center trial. I’ll be writing this report up over the next several weeks/months.
So…we now have evidence based clinical data to support the value of this device on lowering A1C’s. I think this speaks volumes since few (if any) in the constant stream of new diabetes products have produced any randomized, controlled evidence-based trial data to support their efficacy like the GlucoMON now has done. Like you, I’ve been living with diabetes (44 years). This kind of work is professionally and incredibly personally satisfying to see and soon in the literature and meetings. I’ll be speaking to some of these data in 2010 at the ADA Postgraduate Meeting in San Francisco, The ADA Marco Island Conference in Florida in May, and the Endocrine Society in San Diego in June. You might have been in attendance at this year’s ADA Scientific Sessions in New Orleans where I discussed some of this too.
Best regards and Happy Holidays,
Steve Ponder MD, FAAP, CDE
Pediatric Endocrinologist
Professor of Pediatrics
Driscoll Children’s Hospital
Corpus Christi, Texas
Note, lots of exclamation points in the correspondence above. I can certainly understand why Dr. Ponder is excited: In the medial world, everyone’s been long struggling to quantify the impact of data sharing/monitoring devices on patient outcomes – Check! In the patient world, we’ve likewise been wondering whether fussing with all these “extra” devices pays off, and if so, where will we get the evidence to convince insurers to cover this stuff? Check!
Congratulations to Dr. Ponder and the Diabetech team. Note that he’s been tweeting about these results as well.
Interesting device. Thanks for sharing, I’ll have to look into it more.
Hi Amy-
Small request. If you are going to allow such promotion of a device [whether justified or not], shouldn’t you actually decribe what it does and how/why that translates into an improved patient experience. it does not seem that merely knowing one’s glucose levels and recording them has to translate into lower A1C and that seems to be the claim here. What am I missing?? Thanks
Ah, never mind, now I see how this works. The key phrase in the writeup was: [Daily BG monitoring frequency was sustained and at very high levels above norms], i.e. enough daily data is being taken to safely allow behavior modification [dietary adjustments or insulin schedules] so that the frequency and severity of hyperglycemic excursions can be reduced and lower fasting values can be reached while maintaining reasonable safety, thus pushing down average glucose over time. The extension of this mechanism is that one who only infrequently monitors glucose levels would be expected to see no improvement using this device. While this device may provide a significant incentive for more frequent glucose measurements, it will never be a substitute for it.
The GlucoMON is not as much a device as it is a data delivery portal into a wireless system that supports the PWD. We’re often too focused on the technology surrounding our diabetes. The system behind the GlucoMON (quietly running in the background) is what drives the results we saw. First, it was beyond easy to use. Second, it simplified the patient’s data stream and handed it right back to them so they could decide what to do. Third, the medical team was not required to play “air traffic control” with everyone’s BG data (we were not even allowed to see it!). GlucoMON is an empowering feedback tool. Among other things, our study suggests our existing diabetes self care technologies (e.g., SMBG) can be leveraged towards improved control by reducing, not increasing, the users effort!
Ive read this twice and some of the links and still dont understand. Isnt it true that getting more BG data and acting on it is the key ? And also the barrier ? Kids and adults dont test and dont act on it. How does this system help someone who isnt testing and wont act on the tests they take ?
Hi Peeps – this post was not meant to be a product review, but rather an announcement of research results. I provided multiple links to descriptions of the product, and you can also read a little more about it here:
http://www.diabetesmine.com/2008/04/mobile-health-s.html
A “clinical trial” that charges its enrollees for the privilege, and lets its participants self-select.
I believe the true breakthrough here is that the company has figured out how to sell a medical device before FDA approval.
@Felix – who said the study participants were charged? As far as I know, this was a standard clinical study, with no charge to participants and no “self-selection.”
@Amy
There has been a charge to participate since day one
http://mygluco.com/4platinum
“The cost of supporting this research is sometimes sponsored for the participant and in other cases participants are asked to pay all or a portion of the costs of conducting the research.”
This particular study was conducted under a grant from a local diabetes foundation here. In fact the protocol was originally submitted for a Robert Wood Johnson Grant and we made finalist (a high honor) even though the funding was not provided and we went with another grantor. No patient was ever charged for the device or service. All costs were covered by the grant. Actually, GlucoMON’s are never “bought”. They are leased. It would be similar in concept to how you get a cell phone, except that you don’t buy the GlucoMON like you would a cell phone, the company leases the device to a PWD or uses it under a research protocol. Costs are for the access to the wireless network. I hope that helps.
The randomized controlled trial that Dr. Ponder describes above is now published in the ADA’s journal Diabetes Care:
According to a comparison of two studies published in the print edition of “Diabetes Care” in early 2012, frequent pattern management (review of spot blood sugar measurements for trends) made possible by specialized handheld cellular devices, advances in wireless networks and mobile health technology (ie – GlucoMON®-ADMS by Diabetech, LP) delivers superior results compared to either:
Conventional Self Monitoring of Blood Glucose (SMBG) – based on analysis of the recently published ADMS study conducted by the Morris Lichtenstein Medical Research Foundation (Published online before print February 1, 2012, doi:10.2337/dc11-1597 Diabetes Care February 1, 2012) – http://care.diabetesjournals.org/content/early/2012/01/25/dc11-1597.abstract
Continuous Glucose Monitoring systems (CGM/CGMS) – based on analysis of the recently published CGM study conducted by DirecNet (Published online before print; December 30, 2011, doi:10.2337/dc11-1746 Diabetes Care February 2012vol. 35 no. 2 204-210) – http://care.diabetesjournals.org/content/35/2/204.abstract
In summary, this trial proves that at least weekly review of blood sugars for patterns significantly reduces A1c and self-care skills vs. no review which is what pretty much exists for anyone with diabetes today. The technology made it easy for anyone to perform the frequent review.