Priming the Pump: Diabetes Technology Guideline Keeps up with Innovations

Insulin pumps and continuous glucose monitors are changing quickly — and their impact is only expected to grow. Details on how these devices should be used with patients are outlined in a new Endocrine Society Clinical Practice Guideline.

New technologies for monitoring and delivering insulin are well-established in the treatment of diabetes but their use is lagging behind their potential because many endocrinologists hesitate to implement them, according to the lead author of a new Endocrine Society clinical guideline.

The technologies should see greater use, but treatment should be individualized to the patient, says Anne L. Peters, MD, a professor at the Keck School of Medicine at the University of Southern California and chair of the committee that wrote the guideline, “Diabetes Technology — Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline.” [The guideline was published in print in the November issue of The Journal of Clinical Endocrinology & Metabolism and is available online.]

“These technologies are continuously improving and indications for their use are expanding — especially in type 2 diabetes. This document provides a thoughtful set of recommendations as well as a framework for organizing future evidence about [their] effectiveness. It will be helpful to diabetes clinicians by presenting a thorough review of the medical literature to establish which technologies and which indications are supported by high-quality evidence.” – David C. Klonoff, MD, medical director of the Diabetes Research Institute at Mills-Peninsula Health Services in San Mateo, Calif.

Peters says that it was time for a guideline because technology is changing so quickly that it is difficult for both clinicians and researchers to keep up. “Technology keeps advancing so fast that when you study device A, by the time that paper comes out, device C [is already on the market]. The generations of technology are advancing too fast for the studies to keep up,” Peters says.

Despite its goal of writing an evidence-based guideline, the committee had to rely on clinical experience for some recommendations because of this difficulty in keeping up with the pace of technological change, Peters says. She acknowledges that the new technologies are not for everyone, but because they expand patients’ options, she’d like to see the choice made available to as many patients as possible.

Measuring the Benefits

“Insulin pumps are very beneficial in a patient who wants one,” Peters says. “I would argue that every patient with type 1 diabetes who fits the appropriate criteria for being able to use one — and we discuss those in the guideline — should be offered that as a choice,” even though studies show that pumps do not necessarily improve control of hemoglobin A1C compared with injections. “Providers shouldn’t say, ‘you must go on a pump because your control will get better,’ but rather, ‘a pump is one way to treat diabetes, these are your options.’ It is always the user who makes the device work.”

Peters says that studies often cannot measure subjective benefits of the technology. “A lot of the benefits [of technology] that I see have to do with the patient feeling safer or more in control, [or that their] quality of life is better, and those things are not well-measured in studies.”

The guideline stresses that treatment needs to be individualized, and it notes that technology can be difficult to learn to use, hence the caveat about patients being willing and able.

Continuous Glucose Monitors

The guideline recommends that adult type 1 diabetes patients consider using real-time continuous glucose monitors whether their A1C levels are well-controlled or above target. It also recommends the devices for short-term, intermittent use in willing adults with type 2 diabetes who have A1C levels greater than or equal to 7%.

The guideline emphasizes the need for education about the devices: “We suggest that adults with T1DM and T2DM who use continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring receive education, training, and ongoing support to help achieve and maintain individualized glycemic goals.”

Peters says that technology can be intimidating because it takes more training time and commitment on the part of the patient. The guideline acknowledges these challenges by recommending that before prescribing an insulin pump, the physician should assess the patient’s mental and psychological status, record of adherence, interest in the device, and availability for follow-up visits.

The March of Technology

But it notes that modern pumps have come a long way from the early models, which “were heavy, crude syringe pumps with suboptimal quality control, inadequate battery power, and limited dosing flexibility that used infusion sets with rigid needles. Today, there are five Food and Drug Administration-approved pumps available in the U.S. providing numerous features to improve accuracy, safety, dosing decisions, convenience, and overall usability.”

Similarly, technological advances in monitors mean that patients and clinicians no longer need to rely on standard capillary blood glucose measurements — with their discrete values that supply a limited perspective on the constant daily changes in blood glucose levels. Today’s continuous glucose monitors provide alarms that indicate when blood glucose levels are above or below various thresholds and record trends in blood glucose levels. “Current models measure the glucose concentration in the interstitial fluid, and devices are evolving steadily in terms of accuracy and ease of use,” the guideline notes.

“Providers shouldn’t say, ‘you must go on a pump because your control will get better,’ but rather, ‘a pump is one way to treat diabetes, these are your options.’ It is always the user who makes the device work.” – Anne L. Peters, MD, professor, Keck School of Medicine, University of Southern California, Los Angeles

A Good Time to Evaluate Evidence

“CSII therapy and continuous glucose monitoring technologies have been among the most widely used technologies for adults with diabetes over the past ten years. Now is an appropriate time to bring together the evidence for using [both these technologies] in the same evidence-based guideline,” says David C. Klonoff, MD, medical director of the Diabetes Research Institute at Mills-Peninsula Health Services in San Mateo, Calif. Klonoff chaired the committee that wrote a 2011 Endocrine Society guideline on continuous glucose monitoring, but was not involved in writing this current guideline. “These technologies are continuously improving and indications for their use are expanding — especially in type 2 diabetes. This document provides a thoughtful set of recommendations as well as a framework for organizing future evidence about [their] effectiveness. It will be helpful to diabetes clinicians by presenting a thorough review of the medical literature to establish which technologies and which indications are supported by high-quality evidence.”

“This guideline goes into more detail than has ever been compiled to guide clinicians in terms of understanding the right patient for the technology and how to teach the technology,” Peters says. “We involved a diabetes educator on our committee, who was able to give that whole realm of knowledge about using it.”

The American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology co-sponsored the guideline.

Despite the potential benefits of the technology, “we often fail to teach providers how to integrate it in their own practice, so we tried both to summarize the available data and then to help people use it,” Peters says.

— Seaborg is a freelance writer based in Charlottesville, Va. He wrote about the Endocrine Society’s new Clinical Practice Guideline on treating primary aldosteronism in the September issue.