Use of Continuous Glucose Monitors in Type-1 Diabetes: An Analysis of Wave Form Versus Glycemic Values in the Improvement of Glucose Control and Fear of Hypoglycemia

Type-1 diabetes is a disease of subtle complexities. Patients struggle to understand glucose patterns and their responses to insulin or food intake while maintaining hectic lifestyles. Minor misjudgments in treatments can result in disastrous consequences with significant hypo- or hyperglycemic excursions. Despite improvements in technologies available for diabetes management, including home monitoring of blood glucose, more predictable insulin therapies, and improved insulin delivery via insulin pump, the average HbA1c has remained relatively unchanged. Poor diabetes control is recognized as contributing to long-term diabetes comorbidities including neuropathy, nephropathy, retinopathy, and micro- and macrovascular disease. Real-time continuous glucose monitors, such as the Dexcom Seven PLUS, offer a tool with potential to improve glucose pattern management. Their integrated systems of alerts for high and low glucose levels offer an early warning system in the prevention of glucose excursions. While these systems have been available since 2006, adoption into practice has been slow. There is little understanding of how they impact a person\u27s glucose variability and their fear of hypoglycemia. This pilot study used a quasi-experimental design to assess reductions in HbA1c and standard deviations of glucose variability across a 12-week randomized clinical trial. Secondary endpoints included an assessment of change in the level of fear of hypoglycemia, as measured by the Fear of Hypoglycemia Survey tool, and changes in Quality of Life measures, using the Ferrans\u27 and Powers\u27 Quality of Life in Diabetes tool. An open-ended question was conducted on the final visit to elicit the patient\u27s perception of real-time continuous glucose monitors (rt-CGM). Subjects for this trial were persons with Type-1 diabetes, naïve to rt-CGM. They were randomly assigned to either the control group with unmodified Dexcom Seven PLUS devices or rt-CGM devices have been modified to obscure the glucose value but otherwise functioned normally. Subjects were followed through a 12 week trial with data downloads of their rt-CGM performed monthly, and HbA1c testing conducted at enrollment and termination of the study. Findings indicated a reduction in HbA1c, average glucose and standard deviation of the glucose in both the control and the experimental groups. Fear of Hypoglycemia and Quality of Life indicators indicated similar improvements