New Guidelines: Greater Use of Insulin Pumps, CGMs in Diabetes

Miriam E Tucker

September 30, 2016

New clinical practice guidelines endorse the broader use of insulin pumps and continuous glucose monitors (also called sensors) in diabetes patients.

The guidelines, published in the Journal of Clinical Endocrinology and Metabolism, were sponsored by the US Endocrine Society in conjunction with the American Association for Clinical Chemistry, American Association of Diabetes Educators, and European Society of Endocrinology.

The eight-member writing panel that endorsed the new guidelines, led by Anne L Peters, MD, professor of endocrinology at the University of Southern California, Los Angeles, recommends the use of insulin pumps over multiple daily injections of analog-based insulin for most patients with type 1 diabetes who are "willing and able" to use the devices, and they also suggest pump use among selected patients with type 2 diabetes who require insulin therapy.

In addition, real-time continuous glucose monitoring (RT-CGM) is recommended for adults with type 1 diabetes, again who are "willing and able" to use these devices. For type 2 diabetes patients, the document suggests the use of intermittent RT-CGM for those not on premeal insulin with HbA1c levels of 7% or above.

The guidelines also cover patient selection criteria, considerations regarding education, training, and ongoing support for all patients using both devices, and use of the devices in the hospital setting.

Shortly after the guidelines were published, the US Food and Drug Administration (FDA) approved a new artificial pancreas, the MiniMed 670G (Medtronic) ― the first officially approved insulin-delivery system to "close the loop," thereby connecting the insulin pump to the CGM so that the whole apparatus automatically monitors blood glucose and administers appropriate basal insulin doses.

It is approved for use in patients aged 14 years and older with type 1 diabetes. But the MiniMed still requires patients to enter meal information for bolus dosing of insulin.

Dr Peters said that while she welcomes the approval of the Medtronic MiniMed 670G, she believes it is too soon to incorporate this into the guidance.

"We need more data and clinical use to see the risks and benefits [of the artificial pancreas]. The published trial is an observational study and is not rigorous enough for a guideline...but the same principles [as for insulin pumps and CGMs] apply in terms of patient safety, education, and follow-up. I think it is a good step toward the future, but it is still a complex device that requires troubleshooting and mealtime insulin dosing."

She added: "I am very much looking forward to seeing how it works in my patients who are interested in using it. My patients will teach me what its true value is."

Guidelines Will Help PCPs as Well as Endocrinologists

The new guidelines are evidence-based and use the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The panel commissioned one systematic review and used the best available evidence from other published reviews and individual studies.

"These guidelines are to help everybody. from endocrinologists who want to expand their care to primary-care clinicians," Dr Peters told Medscape Medical News, pointing out that "even though many endocrinologists know about prescribing pumps and CGMs, many haven't had the training or [don't have] the bandwidth in their office to do the training that they need."

Indeed, she noted that there are no testing standards or training courses for use of these devices or for interpretation of the data they generate. "We have training courses for thyroid biopsies, but not for interpretation and use of CGM and pumps."

The document was also meant to establish current practice in anticipation of the coming "artificial-pancreas" technologies.

"We're setting the stage for the advances that are coming, by providing a rational framework for what we know so far.…If we're going to layer a level of complexity on top of this with artificial-pancreas systems, we have to have people with some idea of how to help patients troubleshoot….We're going to need even more experts who know how to do this," Dr Peters said, just prior to the FDA approval of the new MiniMed 670G system.

She also stressed that the role of diabetes educators ― represented on the writing panel and in their professional society's endorsement of the guideline ― will also be essential.

What Does "Willing and Able" Mean?

Asked to comment on the document, Simon R Heller, MB, professor of clinical diabetes at the University of Sheffield School of Medicine, United Kingdom, told Medscape Medical News: "Overall I am supportive of the guidance," but he added a few caveats.

"There are welcome comments throughout that both insulin pumps and, in particular, CGMs are successful when people are 'able and willing' to use them, but it isn't entirely clear from the statement what that means.

"I would have liked to see more emphasis that in type 1 diabetes CGM and pumps provide potentially exciting technological support for the very complex task of self-management and that 'success' means active engagement in all aspects of self-care," Dr Heller stressed.

Thus, he continued, "Those who do really well from technology ― from blood glucose testing upward ― are those who engage actively in their self-management."

Technological support won't work for people who think it will manage their diabetes for them, he stressed, but it is important and useful for those who self-manage well to aid the huge effort they put into their condition.

Evidence Weaker for Use of Pumps, CGM, in Type 2 Diabetes

And as far as the guidance for type 2 diabetes, "I personally think the current evidence supporting the use of insulin pumps in type 2 diabetes is rather scant and generally not supported by high-level evidence," Dr Heller observed.

"While I agree that there are individuals who are likely to benefit from pumps, there is a risk that those with type 2 diabetes will be encouraged to believe that their condition will be solved by technology when the main focus ― and always a challenge ― is alterations in lifestyle."

Dr Peters also acknowledged that the type 2 diabetes data were weaker; hence, the "suggested" rather than "recommended" language. "We of course don't have a lot of good data there....I think we need more research on how best to use technology in type 2 diabetes."

The guidelines are also aimed at influencing US payers to cover the technology, including reimbursement of CGMs under Medicare, currently done only under very limited circumstances.

Regarding insurance policies that require criteria such as hypoglycemic unawareness before allowing a patient to access the technology, Dr Peters said: "Our intention was to allow for everyone who wants a pump or CGM to have one....I don't think you should be forced to have a bad low [blood glucose level] before you can get a CGM."

Noted Dr Peters, whose patients include several celebrities and elite athletes, "Type 1 diabetes is an expensive disease. But if you put the money and time into it, people have amazing outcomes. My patients live huge long healthy lives and do what they want to do. To me it's a crime not to offer [technology] to all."

Dr Peters has served or serves as a director, officer, partner, employee, advisor, consultant, or trustee for Abbott Diabetes Care, Becton Dickinson, Bigfoot Biomedical, Biodel, Boehringer Ingelheim, CVS/Caremark, Eli Lilly, Bristol-Myers Squibb, AstraZeneca, Intarcia, Merck, Janssen, Lexicon, Novo Nordisk, Omada Health, OptumRx, and Thermalin. She has served or serves as a speaker or member of a speaker's bureau for Janssen and Eli Lilly and has received research grants from Janssen and Medtronic. Disclosures for the coauthors are listed in the article. Dr Heller has served or serves as a director, officer, partner, employee, advisor, consultant, or trustee for Eli Lilly, Novo Nordisk, Takeda Pharmaceuticals North America, Boehringer Ingelheim, and Merck Sharp & Dohme. She has served or serves as a speaker or member of a speaker's bureau for Eli Lilly, Novo Nordisk, Takeda Pharmaceuticals North America, Merck Sharp & Dohme, and AstraZeneca and has received a research grant from Medtronic UK.

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J Clin Endocrinol Metab. Published online September 2, 2016. Article

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