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.
Final Thoughts
“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.
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