Vigilant met or exceeded all human factors criteria for safety, comprehension and ease of use
Early evidence of clinical benefit was demonstrated by a 51 percent reduction in the proportion of blood glucose readings below 40 mg/dl and a 20 percent reduction in the proportion of readings above 400 mg/dL during Vigilant use compared to baseline.
NEW ORLEANS, June 11, 2016 (GLOBE NEWSWIRE) -- InSpark Technologies, Inc. today announced the presentation of the results of the Home Use and Human Factors Study of VigilantTM, a smartphone-based companion to regular diabetes monitoring that alerts users to periods of risk and provides glanceable summaries of glucose control. The results are being presented at the American Diabetes Association Annual Meeting in New Orleans, Louisiana in the general poster session (867-P) from 12:00 to 2:00 pm CT on June 12th and in a moderated ePoster session from 1:00 to 2:00 pm CT on June 13th in a session entitled “The Role of Glucose Testing and Variability”.
The objective of the study was to determine if subjects with diabetes and their clinicians could understand feedback received from Vigilant about their blood glucose levels and patterns and that the decisions made in response to device feedback did not cause unintended harm. In addition, blood glucose data were gathered for exploratory analyses relating to the clinical benefit of pattern identification.
Vigilant was evaluated in an office setting for 15 diabetes clinicians and 46 diabetes patients who use multiple daily injections of insulin or insulin pump therapy (16 adolescents, 15 adults, 15 elderly). The 46 patients then completed an at-home trial of Vigilant for 30 days. At the end of the study, patients completed ease-of-use and comprehension surveys similar to those completed in the office setting visit. In addition, blood glucose data from the home use period (“Vigilant Period”) were gathered and compared with blood glucose data collected at the initiation of the home use study (“Baseline Period”).
User ratings of device ease-of-use and comprehension met or exceeded all predefined performance criteria. Evaluator ratings of frequent-use or risk-related tasks performed by users also met or exceeded all predefined performance criteria.
Study results comparing the Vigilant period to the Baseline period included the following:
- A 51 percent reduction in the proportion of blood glucose levels below 40 mg/dL (p<0.01)
- A 20 percent reduction in the proportion of blood glucose levels above 400 mg/dL (p=0.06)
- A 5.3 percent decrease in average glucose levels
- A 9 percent decrease in the proportion of readings out of target range (readings below 70 mg/dL or above 180 mg/dL)
- A 5.8 percent average reduction in Average Daily Risk Range (ADRR). ADRR is a measure of glycemic variability shown to be a balanced predictor of future out-of-control results.
“While it is important to recognize this is a small exploratory study, these clinical data provide a compelling profile for testing Vigilant further in larger studies and specific at-risk populations,” said Stacey Anderson, MD, the study principal investor at the University of Virginia Health System. “Also, the human factors and usability results suggest that people find the pattern and risk information presented by Vigilant to be useful and informative.”
Erik Otto, President and Co-Founder of InSpark Technologies, said “These study results further support the strength of Vigilant’s pattern recognition technology and its benefits in identifying periods of risk for people with diabetes. These trial results have led to us initiating two additional ongoing studies designed to evaluate Vigilant’s ability to reduce moderate and nocturnal hypoglycemia.”
Vigilant is a companion to regular diabetes monitoring that analyzes blood glucose data and provides feedback about daily patterns of hyperglycemia, hypoglycemia, glucose variability and test frequency, as well as patterns indicative of increased risk of severe hypoglycemia in the next 24 hours. Vigilant is intended for people with diabetes aged 13 and older who take multiple injections of insulin each day or who use insulin pumps. It is available in the Apple App Store2 and Google PlayTM3 store for download to compatible smartphones. A dedicated web-based caregiver version (“Vigilant Caregiver”) is available for those who assist in the care of people with diabetes.
About Diabetes and Hypoglycemia
Diabetes affects more than 21.9 million Americans, and Type 1 diabetes is the rarer form in which individuals must rely on insulin treatment because their pancreas doesn’t produce enough insulin to regulate their blood glucose. A dangerous and often frequent occurrence in diabetes management, low blood glucose or hypoglycemia can be one of the most frightening aspects of living with diabetes. If left untreated, it can cause loss of consciousness, seizures, coma, or even death. According to the American Diabetes Association, hypoglycemia accounts for more than 282,000 emergency room visits a year.
About InSpark Technologies, Inc.
InSpark Technologies is developing tools that help people with diabetes transform the significant amount of blood glucose data captured on a daily basis into useful insight. InSpark’s technology alerts patients and clinicians about patterns indicative of periods of risk at the time they need it most (such as when a patient is testing, and in advance of the period of risk). InSpark’s technology is derived from a broad suite of pattern recognition intellectual property developed by Drs. Boris Kovatchev, Daniel Cox and Marc Breton, and licensed from the University of Virginia Licensing & Ventures Group. More information can be found at insparktech.com. More information about Vigilant can be found at vigilant.insparktech.com. Follow us on twitter at @insparktech.
- VigilantTM is a trademark of InSpark Technologies Inc.
- iOS and App Store are trademarks of Apple Inc.
- Android and Google Play are trademarks of Google Inc.