AUSTIN -- Patients with uncontrolled type 2 diabetes had significant improvements in HbA1c levels after switching to a 24-hour insulin delivery system from daily insulin injections, according to a new study.
Led by Howard Courtenay Harrison Jr., MD of Endocrinology Consultants in Virginia, 71% of participants were able to achieve a target A1c level of less than 8%, and/or lower his or her HbA1c level at least 1% after switching to the .
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
An average of fifteen weeks following the insulin delivery system switch, Harrison's group reported a reduction in mean insulin total daily dose requirements among the total patient population.
The findings of the EVIDENT (Evaluating V-go Insulin Delivery In Type 2 Diabetes) study were presented at the American Association of Clinical Endocrinologists' annual meeting.
The V-Go system, FDA approved in 2010, is a disposable, continuous subcutaneous basal-bolus insulin device, aimed as a treatment for type 2 diabetes. The system is tested for use with a U-100 fast-acting insulin, and delivers a preset basal rate of insulin during a twenty-four hour period.
Noting that even minor reductions in A1c levels can improve the overall well-being of a patient with uncontrolled type 2 diabetes, Harrison and colleagues stated their goal for the study was to evaluate the extent of the benefits an alternative treatment could potentially provide, given the "limited" therapeutic options available.
Additionally, Harrison's group highlighted that prior data drawn from a large medical claim database suggested only one-fifth of current type 2 diabetes patients have achieved target A1c levels below 7%. They added that it is thought that over 30% of patients with type 2 diabetes may have levels of 9% or higher, therefore highlighting the importance of alternative therapies aiding in glycemic control.
Identified through an electronic medical records database, 89 individuals with uncontrolled type 2 diabetes were included in the retrospective analysis. Administering an average of two or more insulin injections per day, all participants were insulin-users with an A1c of over 8% (9.9 ± 1.4%) at baseline.
Mean patient age was 59 (range 33-89) and 43% were men. About one-third were African American and nearly all the rest were white. Mean BMI was 35.
The within-group analysis switched all participants to a V-Go 24-hour wearable insulin delivery system from a traditional insulin delivery system, such as a syringe or insulin. Prior to intervention, mean baseline total daily dose of insulin was 66 ± 32 U/day (range 10 to 200 U/day). Within thirty days following the conversion to the V-Go system, the researchers assessed overall and percentage change in A1c levels, as well as change in total daily dose of insulin using paired t-tests.
Harrison's group suggested prior non-adherence to specific insulin regimens may have contributed to this population's uncontrolled diabetes. "We attribute this success to improved insulin adherence as well as to insulin being continuously infused and readily available for bolus dosing," the group wrote.
Wide-range clinical application may be limited for the V-Go system, however, according to Jason Ling, MD, of Northwell Health in New York, who was not involved with the study, "There's only one set rate, from my understanding, that you can use the pump with," he told 鶹ý, explaining that required insulin dosing of patients is typically more variable over time -- and one set rate of insulin may be restrictive. However, Ling added that he has had success with the system previously with a patient, adding it was more "finding the right insulin [that worked] for this patient."
Although this study was able to report wide-ranging improvements for patients with uncontrolled type 2 diabetes within a short period of time, additional analyses are required to determine long-term benefits of this type of insulin regimen.
Disclosures
The study was funded by Valeritas, Inc. Harrison disclosed financial relationships with Merck, AbbVie, Eli Lilly. One co-author was a Valeritas employee. Ling reported no relevant disclosures.
Primary Source
AACE 2017
Harrison H, et al "Achievement of glycemic targets in patients with uncontrolled type 2 diabetes when switching to a wearable insulin delivery device for insulin delivery" AACE 2017; Abstract 248.