DIABETES TECHNOLOGY CONTINUES ITS ADVANCE

Technological advances have changed the face of diabetes treatment in recent years, with the advent of continuous glucose monitors and new insulin types to complement improvements in insulin pumps and delivery systems

The new techniques have demonstrated the ability to improve care, but require an investment in education from both practitioners and patients. Innovations can make diabetes management simpler and more effective overtime, but a patient’s commitment and understanding are keys to making them work.

Monitors Improve Care

Experts singled out continuous glucose monitors (CGMs)as being on the cutting edge for improving care because as the monitors shrink and become easier to use, studies back their effectiveness.

Thier evolution has been similar to that of insulin pumps, which were, at first, too big and uncomfortable,said Stephen Ponder, MD, a pediatric endocrinologist at Texas A&M University. The first pumps were challenging to wear and use. Some patients compared the first CGM sensorsto harpoons, but the sensors have become small wires with shallower penetration that no longer cause bruising.CGMs off er long-lived sensors and batteries, safety alarms,and sophisticated software.

A recent literature review by an Endocrine Societyexpert panel confirmed that the monitors improve controlof glycosylated hemoglobin levels while limiting the risk ofhypoglycemia. Th e panel’s clinical practice guideline calls for more widespread use of CGMs by children, adolescent,and adult outpatients.

Th e monitors measure glucose levels in the interstitialfluid and require regular calibration based on bloodprickmeasurements by a glucose meter. CGMs are still notFDA-approved for use in treatment decisions, but patientsregularly use them successfully in off -label fashion for determining the irinsulin doses, said Irl Hirsch, MD, professorof medicine at the University ofWashington Medical Center in Seattle.The additional data they provide can beextremely helpful by enabling the userto quickly spot and respond to upwardand downward trends.

Although the monitors bring tomind children as the target population,adults stand to benefit a great deal.Long-term patients striving to maintaintight blood-sugar control risk episodesof severe hypoglycemia.

Hirsch said that in people who have had diabetes formore than 40 years, the frequency of hypoglycemic seizuresor comas is 12% per year. He described a 63-year-old patientwho was having monthly hypoglycemic events requiringintervention by paramedics, but hasn’t had a single incidentsince he began wearing a CGM two years ago.

Th ere are only a few CGMs currently on the U.S.market. Th e Dexcom G4 Platinum ( for adult use) andthe Medtronic Guardian Real-Time ( for pediatric andadult use) are both standalone CGMs. Th eMedtronic MiniMed Paradigm Real-timeRevel ( for pediatric and adult use) is a combinationCGM and insulin pump [Editor’sNote: See page 7 for information on a recentsafety alert regarding the Medtronic Paradigminsulin pump.] Th e Abbott NavigatorCGM was withdrawn from the U.S. market but is still available in Europe and some other countries.

Th e biggest drawback is, of course, the cost, some $1,000 or more for the meter itself, along with continued cost of consumables.Some insurance plans now cover them, but Medicare does not.

The other difficulty is the learning curve for using them properly. Ponder and Hirsch both said they often see patients who have a bad experience or do not improve quickly and give up on the sensors, often because there is no one in their physicians’ offices who can give them adequate guidance. Compounding that problem is that undercurrent reimbursement models, practices are not paid top rovide the education and training needed for diabetic patients to take advantage of the technology that off ersbetter control of their conditions.

Computer and Phone Tracking

Online data tracking and phone apps sound great, but can they improve outcomes?
Studies say yes.

Ponder’s team developed a program designed to generate easy-to-understand graphs and feedback. They reported last year in Diabetes Care on a randomized, year long clinical trial among 48 children under 12 years old who used standard blood glucose meters and test strips.Th e experimental group received a system that automatically collected their blood glucose values and sent an email with a 21-day blood glucose trending report each night.Th e children in the experimental group had significantly lower glycosylated hemoglobin levels. They also became more meticulous in their diabetes self-care.

There are so many online and phone apps to choose from that narrowing down which to use can be a daunting task. The American Diabetes Association (ADA) offers an online tool called Diabetes 24/7 that is tied into Microsoft’s Health Vault data storage center. The user can import and track factors such as blood glucose, A1C,blood pressure, cholesterol, physical activity, weight,and medications, and share the information with physicians and others, according to Matt Petersen, the ADA’s managing director of medical information and professional engagement.

The program Hirsch considers the “gold standard as far as insulin management” is Care link, a Medtronicproduct. It works with a Med tronic insulin pump, but can download data from most glucose meters.

Phone Apps

In terms of phone apps, the user may need to concentrate onparticular needs they want to address. Hirsch’s patients havehad success with RapidCalc by Gilport Enterprises, an Australiancompany: “It is a bolus calculator that can work on your iPhone or your iPad, for people who are not on pumps.”

Petersen said that the company WellDoc has publishedclinical trial data to back up the effectiveness of itsDiabetesManager System app, which integrates mobilephones and the Internet, but is available only through diseasemanagement organizations such as Alere or throughsome employers. Later this year, the company expects torelease a version available by prescription that will featureautomated clinical coaching, a medication adherence program,and capture and transmission of blood glucose datafor type 2 diabetes patients.

The MyGlucoHealth (Entra Health Systems) glucosemonitor has offered wireless Bluetooth technology to talk with a variety of smartphones for several years, and LifeScan gainedFDA approval for the first monitor with Bluetooth capabilityfor iPhone and other Apple products earlier this year.

Today’s glucose meters are all built with capabilitiesthat make it easy to download a wealth of potentially helpfulinformation, but there is a limiting factor: physiciansthemselves. “Most physicians don’t download glucose meters,” Hirsch said, which is a shame because the data iseasy to see and figure out and “has opened up our eyes as a tremendous tool for both patients to help themselves and for doctors and other educators to help patients.

Insulin Delivery: Pens vs. Syringes

No one claims to have a certain answer: Why are syringesmore popular than pens for insulin delivery in the U.S.,when pens are the standard in Europe? One factor maybe that insulin from pens is more expensive. Another is that European insurance coverage was faster and morecertain to include pens. U.S. insurance coverage has at least been perceived to be spotty, although a study in the Journal of Medical Economics found that 90% of U.S. privateplans cover pens (although sometimes with higherco-pays). And another factor could simply be a resistanceby U.S. caregivers to change.

But pens have been growing in popularity among U.S.patients. “I’ve seen pens catch on in the past four or fi ve years,”Ponder said. Perhaps as basal-bolus therapy became standard,the convenience of the pens became more compelling.

About 20% of Americans with type 1 diabetes use the most expensive option—insulin pumps. The pumps continueto shrink in size and grow in convenience and, ofcourse, off er the advantage of data downloads for tracking insulin use and patient behavior.

Artificial Pancreas on the Horizon?

An artificial pancreas has been called the holy grail ofdiabetes technology, and it appears to be getting closer.Patients already use insulin pumps and continuous glucosemonitors, so couldn’t forming a feedback loop mimicthe job of the pancreas to pump out insulin when it senses the hormone level is low?

Medtronic, the leader in insulin pump and CGM sales,submitted for FDA review in June 2012 a device that ifapproved would be the only integrated insulin pump andcontinuous glucose monitor in the U.S. to feature “low glucosesuspend:” It automatically suspends insulin delivery ifthe sensor glucose value drops below a threshold level. Apump with that feature has been in use in Europe since 2009.

Johnson & Johnson’s Animas division has a similarsystem in trials consisting of a subcutaneous insulinpump, CGM, and software in what it calls the hypoglycemia-hyperglycemiaminimizer system designed to automaticallypredict rises and falls in glucose and respondwith anticipatory insulin delivery.

And there are other researchers attacking the problem.For example, a group at the University of Virginia is adaptinga CGM and insulin pump loop controlled by a smartphone.

Researchers report progress, but Hirsch says: “The problem is, our insulins are not fast enough, our sensorsare not accurate enough, and the algorithms are not quitethere yet to make it so that we can do a better job than avery adherent and knowledgeable patient can do on theirown. Still, these first steps are exciting.” Of course, themany less-than-adherent patients having a hard time controllingtheir glucose levels may benefit the most.

The Promise and the Problem

With the promise of innovations like the artificial pancreas,recent advances may be only the beginning. “I think we are going to see tremendous gains in technology in thenext five years,” Hirsch said. But, he is frustrated that too few physicians are enthusiastic about introducing theirpatients to the benefits of new technology, in large partbecause of reimbursement policies that will not pay for theinvestment of practice time required to educate patientsabout the proper use of gadgets like CGMs.

Ponder said the advances in technology off er greatopportunities, but successful diabetes management continuesto be driven by the motivation of patients to devote theirtime and energy to keeping their blood sugar levels in line,and their physicians can play a key role in leading the way.

—Seaborg is a freelance writer in Charlottesville, Va., and a regular contributor to Endocrine News.

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