ADA 2019: Hypoglycemia and Technology
One of the greatest fears people living with diabetes have is having hypoglycemia, especially severe hypoglycemia. Avoiding hypoglycemia is therefore often a major driver in how people with diabetes evaluate their own care and control. The HbA1c is the gold standard for clinicians to evaluate overall diabetes control in type 1 (T1D) and type 2 diabetes (T2D), but it would be useful to know whether this was as valuable an outcome to patients. This was a discrete choice experimental survey study of 300 individuals with T1D, with an average age of 47 years, and 400 caregivers of children. These individuals were asked to gauge the importance of aspects of diabetes care such as time in range or achieving a target HbA1c. The results of this study showed that, to people with T1D, the most important aspects of care were low blood sugar events per week, high blood sugar events per week, and the cost of diabetes care. The most important components of these aspects were reducing the number of hyperglycemia and hypoglycemia events per week. The same importance in terms of hypoglycemia and hyperglycemia events per week was also placed by the caregiver group. It was more important to the vast majority of those surveyed to reduce hypoglycemia and hyperglycemia events than anything else, with the HbA1c level being the least important factor in both groups.
Technology has eased the burden in the management of diabetes over time, and this has never been truer than in the past decade. Continuous glucose monitoring (GCM) technology has become more and more accurate, and the overnight warnings for hypoglycemia have given people with diabetes a new sense of security. Work presented by Ehrmann et al was done to determine how long it takes wearing a CGM device until a reduction in hypoglycemia occurs and if there are different courses of effect taper for different people with diabetes. This work was a secondary analysis of the previously published HypoDE study. The analysis was done on data from 75 people who wore CGM devices for the first time for a total of 4 weeks. After unmasking of the CGM readout for patients, there was a significant drop in the percent time <70 mg/dL from 6.5% to 2.8%, which was an immediate effect. The time spent <55 mg/dL was also lower after unmasking. There were two groups, though, after further evaluation: those who responded with less hypoglycemia and those who did not. Analysis of these groups showed that, if there is no improvement in hypoglycemia after the first week, then there is unlikely to be an improvement in subsequent weeks. For the group of people who did respond with less hypoglycemia in the study, there was no wear off of the effect throughout the course of the study. This has significant implications in monitoring response when starting CGM devices in people with diabetes. If hypoglycemia improvement of >4% is not seen after the first week of use, GCM might never lead to improvement in hypoglycemia.
There are a great number of other methods to reduce the incidence of hypoglycemia outside of technology utilization. One such method described was a patient-centered educational and supportive approach investigated by Pearson et al in the United Kingdom. They recruited 160 people with T2D who had to call an ambulance for a hypoglycemia event and randomly assigned them to standard therapy for post-hypoglycemia events with their primary healthcare providers or to a nurse-led, structured-care approach involving education about checking fingerstick blood glucose levels more often, about precipitants of hypoglycemia like exercise or fasting, and about tools to treat hypoglycemia. Patients were followed for an average of 42 months, with a minimum follow-up of 12 months. The results showed a significant decrease in overall mortality, and specifically death from cardiovascular events, in the nurse-led intervention group.
Other proposed methods to deal with hypoglycemia were also proposed at the ADA conference this year, including a new soluble, more stable form of glucagon. The results of the phase III clinical trial for dasiglucagon were presented and were very promising. Dasiglucagon is a glucagon receptor agonist that is stable in aqueous solution. This formulation is designed to be used in an auto-injector device similar to an EpiPen for ease of use in the event of severe hypoglycemia. It has been shown to be stable for 24 months if refrigerated and for 6 months if not. The trial was a three-arm study of 170 people with T1D for more than 1 year who stayed the night in a clinical research center to be treated with IV insulin to induce hypoglycemia. Participants were treated with 300 mg dasiglucagon, placebo, or standard glucagon. The median time to plasma glucose recovery was 10 minutes with dasiglucagon, 12 minutes with glucagon, and 40 minutes with placebo. Overall, 99% of those treated with dasiglucagon achieved glucose recovery within 15 minutes versus 95% in 15 minutes with GlucaGen glucagon. Side-effect profiles were similar between dasiglucagon and GlucaGen glucagon and included headache, nausea, and vomiting. Having an emergency treatment for hypoglycemia that is easier to use, that is more stable for storage, and that is as effective as glucagon is a huge boon for people living with T1D and those who care for them.
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