Consensus statement identifies appropriate patients for continuous glucose monitoring

Blevins TC. Endocr Pract. 2010;16.

The increasing complexity of diabetes and the improvement of technologies for controlling the disease prompted the American Association of Clinical Endocrinologists to produce its first consensus statement providing practitioners with recommendations regarding patient selection and future research for continuous glucose monitoring.

“There are many options available to the practitioners and, more importantly, the patient,” Victor Lawrence Roberts, MD, co-chairman of the AACE Continuous Glucose Monitoring Task Force, told Endocrine Today. He added that “most of this new technology is only about 15 years old.

“This document was specifically designed to provide leadership in a specific area of diabetes care and clarity on how to choose proper tools to treat the disease,” said Roberts, who is also professor of internal medicine at the University of Central Florida College of Medicine, Orlando.

Patient selection recommendations

While drafting the document, task force members considered available scientific evidence and pinpointed which patients are appropriate candidates for continuous glucose monitoring (CGM).

According to the task force, personal CGM is suitable for patients with type 1 diabetes who experience hypoglycemic unawareness or frequent hypoglycemia, as well as those with high HbA1c levels or excessive hypoglycemia. Patients without increased hypoglycemia whose HbA1c levels still need lowering are also recommended for personal CGM, as are women who are pregnant or trying to become pregnant.

Other patients who may qualify for personal CGM include children and adolescents with type 1 diabetes who have HbA1c levels lower than 7% or those who have higher HbA1c levels and are able to use the device almost daily. There may be a role for the use of CGM in patients with type 2 diabetes; however, additional well-controlled studies within this patient population are needed to make definitive comments and to guide physicians properly, Roberts said.

Some special patient populations may qualify for personal CGM, but the consensus panel recommends a 2- to 4-week trial period before regular use. This would include children and adolescents who frequently monitor their blood glucose levels and young children with committed families, particularly if the patient has problems with hypoglycemia.

“When managing diabetes, a team effort is required,” Roberts said. “The team does not just include the doctor, the nurse, the educator and the dietitian, but also requires the patient’s personal support system.”

The task force also recommends professional CGM for certain populations.

“If there’s a problem, professional CGM gives the doctor, nurse or diabetes educator a documented data set to analyze,” Roberts said.

Youth, for instance, with shifting treatment regimens or those who experience nocturnal hypoglycemia, hypoglycemia unawareness or postprandial hyperglycemia may benefit from intermittent professional CGM.

Future research goals

The AACE consensus statement also maps out future research goals. Extending studies to include 3 to 5 years of follow-up, investigating methods to improve blood glucose reading accuracy and developing single platform, intuitive software for CGM technology are important areas of exploration. Additionally, examination of CGM’s use in acute care facilities may lead to new indications for hospitalized patients, thereby alleviating the difficulty of diabetes management in these settings.

Research, however, is not limited to patient selection and CGM indications. Product development also remains key. For example, Roberts highlighted Medtronic’s efforts to create an implantable artificial pancreas, also referred to as a closed-loop system.

Further economic analyses are also essential because, although reimbursement for CGM varies by region, overall coverage remains low. ICD-9 codes and insurance companies’ desire for more data contribute to this problem, and studies demonstrating the tool’s cost-effectiveness may increase compensation.

It is hoped that this research and new information will be integrated into future versions of the consensus statement, Roberts said.

“We plan to have new iterations of this document as we acquire more data and published studies. Although we do not know how often new drafts will be published, the current pace of technology may require updates approximately every 2 to 3 years.” – by Melissa Foster

This is an excellent statement, and to my knowledge, it is the first of its kind regarding CGM — a tool that definitely requires attention. CGM is still a fairly new technology, and many people remain unfamiliar with it. This statement, however, provides a framework for its use and also offers guidelines for people who may be confused about the difference between personal CGM use and diagnostic, or professional, use. Furthermore, by employing scientific evidence, the consensus panel strengthened the recommendations’ validity, as evidence-based approaches are difficult to refute.

Nevertheless, the document does not limit the scope of patient selection to populations for whom the data are strong. Instead, it leaves the door open to new indications in other people who may benefit from CGM by speculating on how future research may expand the tool’s value in different patient populations.

As for future areas of research, additional studies in people with type 2 diabetes who are on intensive insulin regimens may prove helpful. I suspect that this population will benefit to the same degree that people with type 1 diabetes do. After a patient with type 2 diabetes reaches the point at which multiple daily insulin injections are required, there is not much difference between them and a patient with type 1 diabetes. Therefore, this is an area that deserves exploration.

The consensus panel also notes that data on CGM use in hospitals are lacking and highlight it as a potential area of research. Monitoring glucose levels in this setting is difficult, and a great deal of hypoglycemia is probably being missed. The use of CGM might open a lot of eyes as to what the pattern of glucose control really is in patients who are in the hospital.

The statement also mentions the need for further studies in pediatric patients. Behavioral research aimed at improving motivation in adolescents, for instance, could be particularly helpful when dealing with this population.

Overall, this document is comprehensive and incorporates the current data available on CGM. This is a great start, but the development of this technology is moving so quickly that updates to the consensus statement during the next couple of years are essential. The consensus panel should continue to create recommendations using the same methods and manner. Again, the statement is very well done and will benefit both patients and practitioners.

– Jennifer B. Marks, MD
Professor of Medicine, Division of Endocrinology, Diabetes and Metabolism
Diabetes Research Institute, University of Miami Miller School of Medicine
Section Chief, Endocrinology, Diabetes and Metabolism
Director, Diabetes Management Program, Miami VA Medical Center

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