Experts call for increased standardization of insulin pump management

Insulin pumps have existed for more than 30 years, but the rapidly rising number of patients using these devices underscores the importance of management, especially concerning issues such as identifying patients who would benefit most from the technology, providers who can offer comprehensive clinical supervision and requirements for patient training programs.

A consensus statement published by the American Association of Clinical Endocrinologists addresses these problems, and experts said they hope that it provides a context for the tool’s use in clinical practice.

“More and more patients are using insulin pumps, but currently no guidance exists on what to do in terms of both appropriate patient and provider selection and the issue of safety,” George Grunberger, MD, chairman of the AACE Task Force on Insulin Pump Management, told Endocrine Today.

Grunberger said most information offered to the public derives from pump manufacturers or FDA reports on adverse events that may come from patients who did not consult their physicians about proper pump use.

“There is a need to provide some balance to the messages that patients and providers receive,” he said.

Patient selection

Good candidates for insulin pumps are patients with type 1 diabetes who perform at least four insulin injections and at least four self-monitored blood glucose measurements daily, according to the consensus statement. These patients not only have a genuine medical need but also exhibit an ample amount of commitment to their treatment.

“The patient must be interested, ambitious and dedicated enough to care about what happens,” said Grunberger, who is also founder of the Grunberger Diabetes Institute and professor of internal medicine, molecular medicine and genetics at Wayne State University. “You get out what you put into the technology.”

Additionally, the consensus panel recommended insulin pumps for emotionally mature patients with stable home lives and those with a readiness to communicate often with their providers and the ability to learn about proper pump use.

Using this technology in children is even more challenging; some research suggests that the therapy may reduce the risk of hospitalization in children with recurring diabetic ketoacidosis.

Providers should be cautious, however, about parents with unrealistic expectations or those who may not be willing or able to operate the pump properly, experts said. They should also consider concerns unique to the pediatric population, such as puberty, menses, parental situations and school or camp attendance.

Although the primary indication for this technology is in patients with type 1 diabetes, certain patients with type 2 diabetes, including those who require at least four insulin injections daily, may benefit from the therapy.

Prescriber criteria

Currently, no standardized guidelines exist for which providers can prescribe insulin pumps, and any physician today can prescribe an insulin pump, even without any experience with its use, according to the task force.

Grunberger highlighted how a lack of medical supervision and inappropriate patient use may complicate insulin pump use, leading to adverse events that are otherwise preventable.

Nevertheless, identifying provider selection criteria proves challenging. Grunberger said the task force was unable to determine whether a provider’s training, practical experience or other factors would designate the best candidates for proper prescribing, although task force members said raising the issue and generating questions were important to creating awareness of the problem and stimulating progress.

It is hoped that once guidelines are established, a standard certification process can be developed, Grunberger said. This idea falls outside of the consensus statement’s current scope, however.

Patient training

Currently, when patients receive insulin pumps, the company typically sends a trainer to the patient’s home or physician’s office to explain and demonstrate appropriate pump use. However, a patient can refuse this training and instead attempt to operate the device without proper instruction. Books and manuals penned by patients and practitioners are also available, Grunberger said, but standardized clinical supervision remains absent.

The task force recommended extensive education about issues such as catheter insertion and frequent glucose monitoring, as well as the meaning of pump alarms, possible adverse events and the importance of having backup supplies. Periodic re-testing was also endorsed by the consensus panel.

Grunberger said a standard certification process would be helpful, as would a national registry listing patients using insulin pumps, those who prescribed the devices and patient outcomes. Eventually, this information may provide a foundation for the development of specialized centers with certified individuals who can train and supervise patients.

Grunberger said, however, that these are all areas of future research, and the current consensus statement, which will undergo updates as new data become available, is only a precursor to improved implementation of insulin pumps.

“This is an opening statement,” he said. “The idea was to alert both professionals and lay people that the technology is here, it can improve patients’ quality of life when used appropriately, that outpatients require help with pump management and that industry needs to continue exploring advances in device development.”

Follow EndocrineToday.com on Twitter.