Insulin pump therapy and real-time, continuous glucose monitoring are recommended for people with both poorly controlled and well-controlled type 1 diabetes who are willing and able to use the devices, according to a new clinical practice guideline from the Endocrine Society.
The guideline task force also recommended insulin pump therapy for patients with poorly controlled type 2 diabetes as well as short-term, intermittent use of continuous glucose monitoring (CGM) when appropriate. The American Association for Clinical Chemistry, the American Association of Diabetes Educators and the European Society of Endocrinology co-sponsored the guideline.
The timing of the guideline was designed provide reliable guidance as development of artificial pancreas systems are underway, said Anne L. Peters, MD, director of the University of Southern California Clinical Diabetes Program and professor at the Keck School of Medicine of USC.
Anne L. Peters
“Technology is advancing quickly,” Peters told Endocrine Today. “It is hard for guidelines, which rely on published data, to keep up. “Rather than always playing catch up, this seemed the perfect time to create guidelines for pumps and sensors so that we are poised for the advent of the artificial pancreas.”
In developing the guideline, the task force commissioned a systematic review and individual patient data meta-analysis of 11 randomized controlled trials enrolling patients with type 1 diabetes and comparing real-time CGM vs. control groups. Researchers used a two-step regression model to pool patient data from trial lists and device manufacturers.
Researchers found that the use of real-time CGM was associated with a mean –0.276% reduction in HbA1c (95% CI, –0.465 to –0.087) vs. controls. Researchers did not observe between-group differences for time spent in hypoglycemia or the number of hypoglycemic episodes, but acknowledged analyses were imprecise.
Researchers made six recommendations regarding use of the technology:
Insulin pump therapy without sensor augmentation is recommended for patients with type 1 diabetes who either have not met their HbA1c goal or reached their HbA1c goal but continue to experience hypoglycemia or glucose variability, as well as for those who require increased insulin delivery flexibility.
Insulin pump therapy is recommended for patients with type 2 diabetes with poor glycemic control despite intensive insulin therapy, oral agents, other injectable therapies and lifestyle modifications.
Insulin pump therapy should be continued in the hospital setting for patients with type 1 or type 2 diabetes, if the institution has clear protocols in place for appropriate monitoring and safety procedures.
Clinicians should perform a structured assessment of a patient’s mental and psychological status, prior adherence to self-care measures and willingness and interest in trying any device before recommending insulin pump therapy.
Patients should be encouraged to use appropriately adjusted, embedded bolus calculators in insulin pump therapy and have appropriate education regarding their use.
CGM is recommended for patients with type 1 diabetes who have not met their HbA1c target and those with well-controlled diabetes who are willing and able to use the devices on a near-daily basis; short-term, intermittent use is recommended for patients with type 2 diabetes not on prandial insulin with an HbA1c of at least 7%.
The researchers recommended that patients using pump therapy or CGM receive training and education to safely and effectively use the devices.
“I hope [the guideline] will focus people on the user, rather than the technology, per se,” Peters said. “Education, of both providers and patients, is key for success, as is ongoing interpretation and feedback. We have good tools in existing pumps and sensors. Ideally, we will be using them in more and more people, but, we need to provide the support people need in order for them to be successful.” – by Regina Schaffer
For more information:
Anne Peters, MD, can be reached at the USC Clinical Diabetes Program, 150 N. Robertson Blvd, Suite 210, Beverly Hills, CA 90211.
Disclosure: Peters reports significant financial interest or leadership positions with Abbott Diabetes Care, AstraZeneca, BD, Biodel, Boehringer Ingelheim, Janssen, Lilly, Medtronic, Merck and Novo Nordisk,. Please see the full clinical practice guideline for the other authors’ relevant financial disclosures.