Real-world data and the retrospective analyses announced in poster presentations at AGS and AACE Annual Meetings
BRIDGEWATER, New Jersey, May 18, 2015 /PRNewswire/ —
Valeritas Inc. announced today that the real- world data and retrospective analyses from an ongoing study at the Meadows Nursing & Rehab Center, Dallas, PA, demonstrated that V-Go helps to control blood glucose levels and reduce insulin requirements in long-term care residents. The preliminary data were disclosed in two poster presentations, one at the American Geriatric Society (AGS) 2015 Annual Scientific Meeting in National Harbor, Maryland and the other at the American Association of Clinical Endocrinologists’ (AACE) 24th Annual Scientific and Clinical Congress in Nashville, Tennessee.
V-Go is a simple, wearable, basal-bolus insulin delivery solution for patients with diabetes that enables patients to administer a continuous, preset basal rate of insulin over 24 hours and provides on demand bolus dosing at mealtimes with one insulin.
“We have learned from these analyses that V-Go has the potential to make an impact for patients with diabetes in the long-term care setting. These data produced encouraging results for patients and we intend to explore this further,” said Valeritas CEO Kristine Peterson.
Four patients were included in the initial analysis presented at the AGS. The study subsequently expanded to eight patients. Preliminary data on this total were reported at AACE.
The poster titled, Improved Glycemic Stability With Reduced Injections Utilizing V-Go® Disposable Insulin Delivery Device In The Long-Term Care Setting, was presented at the AGS.
Noting that controlled diabetes mellitus (DM) and fluctuations in blood glucose present a significant problem for patients and their caregivers at LTC facilities, the objective of this study was to determine the general impact of using V-Go in this setting.
As reported at AGS, the average age was 79. All were on insulin therapy before switching to V-Go. Data showed improved glucose control and reduced blood glucose fluctuations. Blood glucose data were collected four times daily from each patient, beginning one-month prior to switching to V-Go and for the month using V-Go insulin delivery. Time in Range (defined as blood glucose 100 – 200 mg/dl) increased to 56.2% from 45.1% pre-V-Go, reflecting a 19.8% increase. Glucose excursions were reduced by 32%. The number of injection sites also decreased. Based on the results, it was calculated that these four patients saved approximately $1,746/month for nursing/labor costs and $220/month for insulin costs.
The poster titled Improved Glycemic Control Utilizing Basal Bolus Insulin Delivery with the V-Go Disposable Insulin Delivery Device In the Long-Term Care Setting, was presented at AACE. The purpose of this analysis was to assess whether introducing V-Go to patients requiring insulin therapy in the LTC setting could improve glycemic control and reduce glycemic fluctuations. Participants had an average age of 81 years. All were on existing insulin therapy regimens prior to switching to V-Go. Following the switch, patients demonstrated favorable changes in glycemic control and time in the target euglycemic range. Specifically, the pre-V-Go mean BG (SD) was 202 mg/dL (30.7) and the Post-V-Go was 180 mg/dL (29.7), corresponding to a calculated A1C change from 8.67% to 7.89%. The Time in Range during V-Go therapy increased to 54% from 43% pre-V-Go. Pre-V-Go glucose excursions above 200mg/dl were 48% and decreased to 34% while on V-Go therapy.
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About the V-Go® Disposable Insulin Delivery Device
V-Go® is a small, discreet, wearable and easy-to-use disposable insulin delivery solution for the delivery of basal-bolus insulin therapy in adults with Type 2 diabetes. V-Go enables patients to closely mimic the body’s normal physiologic pattern of insulin delivery by releasing a single type of insulin at a continuous preset basal rate over a 24-hour period and also providing for on-demand bolus dosing at mealtimes. V-Go® is mechanical and operates for 24 hours without electronics, batteries, infusion sets or programming. It is worn on the skin under clothing and measures just 2.4 inches wide by 1.3 inches long by 0.5 inches thick, weighing approximately one ounce when filled with insulin. Important Risk Information: If regular adjustments or modifications to the basal rate of insulin are required in a 24-hour period, or if the amount of insulin used at meals requires adjustments of less than 2-Unit increments, use of the V-Go Disposable Insulin Delivery Device may result in hypoglycemia. The following conditions may occur during insulin therapy with V-Go: hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). Other adverse reactions associated with V-Go use include skin irritation from the adhesive pad or infections at the infusion site. V-Go should be removed before any magnetic resonance imaging (MRI) testing.
About Valeritas, Inc.
Valeritas is a commercial-stage medical technology company focused on developing innovative technologies to improve the health and quality of life of people with Type 2 diabetes. Valeritas’ flagship product, the V-Go ®, is the first, simple, wearable, basal-bolus insulin delivery solution for patients with Type 2 diabetes that enables patients to administer a physiological, continuous, preset basal (continuous) rate infusion of insulin over 24 hours. It also provides on demand bolus dosing at mealtimes. It is the only basal bolus insulin delivery system on the market today specifically designed keeping in mind the needs of type 2 diabetes patients. Headquartered in Bridgewater, New Jersey, Valeritas operates its R&D functions in a state-of-the-art facility in Shrewsbury, Massachusetts. For more information, please visit http://www.valeritas.com.
SOURCE Valeritas Inc.