REAL-TIME CONTINUOUS GLUCOSE MONITORING IN THE MANAGEMENT OF TYPE 1 DIABETES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Diabetes Control and Complications Trial (DCCT) clearly demonstrated the importance of glycemic control in preventing and delaying the microvascular complications of type 1 diabetes (T1D) but at the cost of a 3-fold increase in the frequency of severe hypoglycemia and a 2-fold increase in the frequency of excessive weight gain. The DCCT also demonstrated that achieving and maintaining target glucose and HbA1c levels was more difficult in adolescents than adults with T1D. Compared with intensively treated adults, intensively treated adolescents in the DCCT had higher HbA1c levels, a 60% increase in the risk of severe hypoglycemia, and the same 2-fold increase in the rate of obesity. Despite increased use of insulin pumps and multiple injection regimens and the introduction of rapid and long-acting insulin analogs, the majority of individuals with T1D fail to achieve target HbA1c levels recommended by the DCCT more than 12 years ago. While self-monitoring of blood glucose plays an important role in achieving target HbA1c levels, most patients measure glucose levels infrequently immediately after meals and during the overnight period. Consequently, post-prandial hyperglycemia and asymptomatic nocturnal hypoglycemia are commonly oberved even in well-controlled individuals with T1D. In addition, the fear of hypoglycemia by patients, and for children's parents, is a major obstacle to successful intensive insulin therapy, and the lack of overnight monitoring is a problem since more than 50% of severe hypoglycemic events occur during sleep. Increasing the frequency of glucose monitoring was an important aspect of attaining improved glucose control in the DCCT. However, resistance to frequent blood glucose monitoring is a major impediment to attaining good (lower HbA1c level) glucose control. Real-time continuous glucose monitoring (RT-CGM) offers the opportunity to improve glycemic control, including reducing rather than increasing the incidence of severe hypoglycemia as control is "tightened". The GlucoWatch Biographer was the first "real-time" glucose sensor made available for daily use by patients. Unfortunateily, it was not tolerated well and few children found it to have long-term utility. Recently, several RT-CGM systems were approved by the FDA: the DexCom STS Continuous Glucose Monitoring System (DexCom, Inc.) and the Paradigm and Guardian REAL-Time Continuous Glucose Monitoring Systems (Medtronic Minimed). The same sensor is used by the Paradigm and Guardian systems. Therefore, for this protocol we are considering the Paradigm and Guardian devices as the same device. An additional RT-CGM system, the FreeStyle Navigator Continuous Glucose Monitoring System (Abbott Diabetes Care, Inc.) has been evaluated by the Diabetes Research in Children Network (DirecNet) and is expected to receive FDA approval shortly. The proper role of the RT-CGM in the management of T1D has not been determined. Clinical trials of RT-CGM technology are critically important to demonstrate that this technology is effective and to provide information on how it should be implemented and used. The primary objective of the study is to determine if RT-CGM can imporve glycemic control and quality of life in children and adults with T1D. In addition, an evaluation of the cost-effectiveness of RT-CGM will be conducted.