Continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) represent 2 of the recent technological advances in diabetes care that aim to improve glucose control and quality of life and minimize hypoglycemia. Reliable data on such technology are scarce, however, due to the rapid pace of advancement in such products and the less stringent US Food and Drug Administration (FDA) regulation—and thus less demand for clinical trials—of medical devices compared with pharmaceuticals.
In September 2016, a task force appointed by the Clinical Guidelines Subcommittee of the Endocrine Society published a practice guideline pertaining to the use of CSII and CGM technologies in adult patients with type 1 diabetes and type 2 diabetes, based on a thorough review of relevant studies. The guideline is co-sponsored by the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology.
“I think the guideline is making more clinicians aware of the established role of technology in the treatment of diabetes,” said Task Force Chair Anne L. Peters, MD, director of the clinical diabetes program and professor at the Keck School of Medicine at the University of Southern California in Los Angeles.
“It is a good starting point for a field that is rapidly advancing,” she told Endocrinology Advisor.
The task force made recommendations that they considered either strong or weak based on the quality of the evidence available. For the former, they used the term “recommend,” and for the latter, they used the term “suggest.” They denoted the quality of evidence for each area reviewed, which ranged from very low quality to high quality. “The Task Force has confidence that persons who receive care according to the strong recommendations will derive, on average, more good than harm,” they stated in the document. “Weak recommendations require more careful consideration of the person’s circumstances, values, and preferences to determine the best course of action.”
Throughout the 6 covered areas below, the guideline authors emphasize the importance of patient and caregiver training and education, as well as capability and willingness to use the devices.
“Educating our patients on the use of these technologies is vitally important,” Matthew Freeby, MD, director of the Gonda Diabetes Center and associate director of diabetes clinical programs in endocrinology at the David Geffen UCLA School of Medicine, said in an interview. “Providing education increases the chances of using them well and ensuring safety.”
1. Insulin pump therapy without sensor augmentation
The authors recommend CSII vs analog-based basal-bolus multiple daily injections in patients with type 1 diabetes who have not achieved their HbA1c goal, as well as those who, despite having achieved their HbA1c goal, continue to have severe hypoglycemia or high glucose variability.
They also suggest CSII for patients with type 1 diabetes in need of more insulin delivery flexibility or improved satisfaction. “The flexibility provided by CSII with rapid-acting analog insulin could be an advantage for those who exercise and potentially those with gastroparesis because the basal delivery dose and pattern can be modified,” they explained in the paper.
The guideline offers a detailed description of how to select candidates for insulin pump therapy.