November 16, 2016
Guidelines for CGM and CSII in Diabetes
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. The fact that type 2 is even mentioned should be an encouragement that there may be hope for us to obtain this equipment.
“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.
#2. Insulin pump therapy in type 2 diabetes. The task force suggests CSII for patients with type 2 diabetes who have poor glycemic control despite all reasonable efforts with insulin or other injectable therapy, oral agents, and lifestyle modifications.
#3. Insulin pump use in the hospital. The guideline authors suggest continuation of CSII in patients with type 1 diabetes or type 2 diabetes who are admitted to the hospital, as long as the hospital has established protocols for evaluating and monitoring the use of CSII in such patients. This approach is supported by both the American Diabetes Association and the American Association of Clinical Endocrinologists.
#4. Selection of candidates for insulin pump therapy. Before prescribing CSII, the authors recommend that clinicians conduct a comprehensive assessment of the patient's mental and psychological status, history of adherence to other self-care measures pertaining to the disease (such as carbohydrate counting and sick-day rules), availability for necessary follow-up visits, and willingness to use the device.
#5. Use of bolus calculators in insulin pump therapy. The task force suggests that clinicians encourage “patients to use appropriately adjusted embedded bolus calculators in CSII and have appropriate education regarding their use and limitations.” They do not recommend the use of non-CSII insulin calculators, such as those available via smartphone apps, which are not FDA-approved.
#6. Real-time continuous glucose monitors in adult outpatients. The authors recommend real-time CGM devices for patients with type 1 diabetes and above-target HbA1c levels, as well as those with well-controlled type 1 diabetes, who are capable of using such devices almost daily. They suggest short-term, intermittent real-time CGM use in adults with type 2 diabetes who are not on prandial insulin and have HbA1c levels ≥7%.
They suggest that both patients with type 1 diabetes and type 2 diabetes using CSII and CGM receive appropriate education, training, and support to achieve and maintain their glycemic goals. They note that data showing improved long-term glycemic control using GCM underscores the importance of the patient's skill in using the new technology.
“The authors of this guideline did an excellent job reviewing the recommendations based on the current available data,” said Dr Freeby. “As stated in the guideline, there are plenty of data to support the benefits of pump therapy and continuous glucose monitoring in type 1 diabetes, and anecdotally, these therapies really work in day-to-day practice.”
Dr Peters hopes clinicians will be excited about data analysis and how the new devices can help patients. “I don't think they should be oversold—type 1 diabetes is still a challenge, but these are all steps on the way to more fully automated systems,” she said.