Abstract
Two articles in this issue illustrate the potential benefits and limitations of new technologies: Schmidt and Nørgaard 1 report on the durable benefit of sensor-augmented pump therapy in a small number of adult patients with T1D, and Realsen et al. 2 address potential dangers of pump therapy in children with T1D. The Diabetes Control and Complications Trial 3 established, for patients with T1D, the benefit of intensive insulin therapy with multiple daily injections or insulin pump use and close follow-up by a diabetes care team. The improvement in hemoglobin A1c (A1C) came at a price, a marked increase in hypoglycemia. This was particularly true in the youngest subjects, the adolescent cohort. Subsequent therapeutic development has focused on improving A1C and diminishing the risk for hypoglycemia. The development of rapid- and long-acting insulin analogs has arguably improved both postprandial glucose elevations as well as fasting and nocturnal hypoglycemia. Pumps offer the ability to more precisely deliver smaller and markedly more precise quantities of insulin. For that reason they are an attractive option for younger children, who have marked insulin sensitivity and are generally more injection-averse. Continuous glucose monitoring (CGM) has begun to address both ends of the glycemic spectrum. Despite these advances, glycemic targets remain elusive for the majority of our patients, and the management of T1D remains an intrusive burden on patients and their families.
CGM presents the opportunity for patients and their diabetes care providers to benefit from greater granularity of glucose data, but there are notable limitations. CGM devices have yet to achieve the accuracy of blood glucose monitoring, and CGM remains dependent upon self-monitoring of blood glucose (SMBG) for calibration. In addition, SMBG is still recommended for making acute treatment decisions. The size of sensor electrodes, site selection, and discomfort remain barriers to wider acceptance among children. These concerns also impact adherence and clinical efficacy for those initiating CGM use. Several studies, including the Juvenile Diabetes Research Foundation (JDRF) Continuous Glucose Monitoring Study, 4 have highlighted limitations of CGM, particularly for those populations at highest risk for acute and eventual chronic complications. Findings of the JDRF study, conducted in 322 randomized T1D patients over a 26-week period, showed that CGM, in conjunction with intensive insulin regimens, lowered A1C in selected adults (age ≥25 years) with T1D. This older group achieved a 0.5% reduction in A1C (from approximately 7.6% to 7.1%) compared with usual intensive insulin therapy with SMBG. Although the evidence for A1C lowering was less strong in children, teens, and younger adults, CGM also appeared to be helpful in these groups as well. The greatest predictor of A1C lowering for all age groups was frequency of sensor use, which was lower in younger age groups. Although there was no statistically significant difference in hypoglycemia between any of the groups, it was suggested that CGM may be a valuable adjuvant to SMBG in those patients with hypoglycemia unawareness and/or frequent episodes of hypoglycemia. In theory, CGM should improve blood glucose control by offering less invasive and more immediate feedback that leads to altered behavior resulting in tighter blood sugar control while more effectively addressing the ever-present fear of serious hypoglycemia leading to embarrassing loss of control in the best-case scenario and a “dead-in-bed” scenario in the worst.
Technology-assisted diabetes management in 2012 remains dependent upon the patient's active engagement and adherence to a complex management plan in order to achieve improved control. As reported by Realsen et al. 2 at the Barbara Davis Center for Childhood Diabetes, Aurora, CO, therapies require intensive education not only to maximize the potential benefits, but also to minimize potential adverse events. In the case of pump therapy, caretakers must master the concepts of basal-bolus therapy, basic pump operation, infusion set preparation and placement, and, ideally, advanced pump features including square-wave/dual-wave boluses, temporary basal rates, and trouble-shooting skills.
Adherence is a particular challenge in adolescents and young adults. As was highlighted in the American Diabetes Association position statement on transition of diabetes care, 5 adolescents and young adults with T1D are a high-risk population. This is a consequence of their independence-seeking, risk-taking developmental stage coupled with, all to often, the failure to adequately transition from pediatric to adult diabetes care providers. Concerted efforts by the American Diabetes Association, American Association of Clinical Endocrinologists, Endocrine Society, Pediatric Endocrine Society, National Diabetes Education Program, Centers for Disease Control and Prevention, JDRF, Children with Diabetes, American Academy of Pediatrics, and the American College of Osteopathic Family Physicians are focused on putting tools in the hands of adult and pediatric diabetes care providers and patients and their families to facilitate and promote more effective transition of this vulnerable population. Effective mitigation of current barriers will require novel strategies by dedicated families and their diabetes care teams thinking “outside the box” utilizing relevant venues such as social media (e.g., Facebook, twitter, tumblr) to engage, educate, and motivate these patients. Additional strategies may include improved integration of increasingly available “personal diabetes health records” with individual hospital electronic health records and across systems to facilitate blood glucose, CGM, and pump data transfer and communication between patients and their diabetes care providers and among the providers themselves.
Insurance coverage remains a constant battle for patients seeking coverage for basic diabetes care supplies necessary for blood glucose monitoring and insulin administration and even more so for the newer technologies. It is not unusual for carriers to request months of blood glucose data or poor control as evidenced by an elevated A1C prior to considering coverage for pump therapy or CGM. The landscape is slowly improving in response to advocacy efforts by JDRF and others and favorable legislation. The Affordable Care Act addressed the loss of coverage for young adults, who can now remain on their parents' insurance plans until 22 years of age. Also, the Affordable Care Act eliminated denials for “preexisting conditions.”
New technologies, to date, only ease the burden of care. Until we achieve a cure or the “closed-loop system”/“artificial pancreas,” these technologies are merely better tools that enable educated, committed patients and their families to actively pursue optimal blood sugar control in daily lives. It is incumbent upon the diabetes care community to best prepare these individuals to be active partners in achieving optimal blood sugar control while we continue to advocate for the support necessary to accelerate development of cure therapeutics and technologies that will permit a biological or functional cure.