InSpark Technologies Announces the Results of the Home Use and Human Factors Study of Vigilant™ in People with Diabetes

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, LA, June 11, 2016--InSpark Technologies, Inc today announced the presentation of the results of the Home Use and Human Factors Study of Vigilant, 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 Store and  Google Play 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.

 

InSpark Contact:

Diane Johnson,

DTJ.Org Public Relations & Marketing on behalf of InSpark Technologies Inc.

703-203-7746 

diane@insparktech.com

 

1.  Vigilant is a trademark of InSpark Technologies Inc.

2.  iOS and App Store are trademarks of Apple Inc.

3.  Android and Google Play are trademarks of Google Inc.

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InSpark Technologies Enters into Clinical Trial Collaborations to Study the Effectiveness of Mobile Health Technology in Preventing Low Blood Sugars in People With Diabetes

The Vigilant Diabetes Management Companion alerts users in advance of periods of risk and provides glanceable summaries of glucose control

Charlottesville, VA -- InSpark Technologies, Inc. announced today that it has entered into clinical study collaborations with Atlanta Diabetes Associates, a large clinical practice in Atlanta, Georgia, and East Carolina Diabetes and Obesity Institute, a research center of East Carolina University. The studies will evaluate the impact of a new mobile health application – the Vigilant Diabetes Management Companion – for the prevention of nighttime and moderate low blood glucose in individuals with Type 1 diabetes. 

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. Nighttime or nocturnal hypoglycemia is one of the most common types of hypoglycemia in individuals with diabetes using insulin and is particularly dangerous as it often goes undetected.

“Clinical trial collaborations with premier industry leaders are an essential element of our strategy to realize the full potential of Vigilant and demonstrate InSpark Technologies’ leadership in digital health solutions for diabetes," said Erik Otto, Co-Founder and President of InSpark Technologies. “We are looking forward to collaborating with both of these highly respected organizations to study Vigilant in diabetes populations who up to this point have had few non-invasive options for being alerted to the risk of hypoglycemia.” 

Each study will enroll participants who will download Vigilant to their iOS or Android mobile device.  Each participant will check his or her blood glucose levels throughout the day using a wireless blood glucose meter that communicates with Vigilant.  Vigilant will analyze the person’s blood glucose data, provide concise summaries about his or her daily glucose patterns and send alert messages to the patient and caregivers about periods of risk.

Researchers at Atlanta Diabetes Associates will be evaluating Vigilant’s impact on mild, moderate and severe hypoglycemia. "We are excited to be working with InSpark Technologies to evaluate the potential of this novel technology to improve clinical outcomes for people with diabetes," said Bruce Bode, MD, president and chief executive officer of Atlanta Diabetes Associates.  “Hypoglycemia in diabetes is one of the largest barriers to good control and having technologies available that may help prevent it is important to both the quality of life of individuals as well as the potential to improve overall clinical outcomes.”

ECU researchers will be studying Vigilant’s effectiveness in helping people with nocturnal hypoglycemia.  “Nocturnal hypoglycemia is one of the biggest fears people with diabetes and their families experience,” said Robert Tanenberg, MD, medical director for the East Carolina Diabetes and Obesity Institute.  “Recognizing when one is at risk for a severe or dangerous low blood glucose and taking measures to prevent it are cornerstones of good diabetes management. We are looking forward to evaluating this technology’s ability to assist in this area.”

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 Store and Google Play 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.  More information about Vigilant can be found at vigilant.insparktech.com.

 

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 and Ventures Group.  More information can be found at http://insparktech.com. Follow us on twitter at @insparktech.

InSpark Contact: Diane Johnson,  DTJ.Org Public Relations & Marketing on behalf of InSpark Technologies Inc. 

diane@insparktech.com or 703-203-7746

 

About East Carolina Diabetes and Obesity Institute (ECDOI) at East Carolina University

The ECDOI is an interdisciplinary research institute jointly supported by the ECU Divisions of Health Sciences and Research & Graduate Studies. The ECDOI is well known for cutting-edge collaborative research in several fields related to disorders of metabolism, including bariatric surgery, muscle insulin signaling/glucose transport, bioenergetics/exercise physiology, and pediatric healthy weight programs. The mission of the ECDOI is to promote and coordinate interdisciplinary basic and translational research programs in diabetes and obesity, to support the education and training of undergraduate, graduate and post-graduate students, and to foster the development of outreach prevention/treatment programs for the people of eastern North Carolina.

ECU Contact: Amy A. Ellis, public communication specialist,

Brody School of Medicine at East Carolina University

Ellisa14@ecu.edu or 252-744-3764

 

About Atlanta Diabetes Associates

Atlanta Diabetes Associates is an endocrinology & metabolism practice. Our board certified endocrinologists have decades of experience in diabetes and endocrine care. We dedicate ourselves in providing optimal healthcare services relating to diabetes and other endocrine disorders.

Our medical staff at Atlanta Diabetes Associates combines extensive experience, compassion and the latest technology in addressing your health care concerns. We are committed to patient education and participation in the implementation of treatment plans so that the best care can be provided.

We also offer clinical trials so that patients are able to access treatments that are still in the investigational stages.

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 1.   Vigilant is a trademark of InSpark Technologies Inc.

2.     iOS and App Store are trademarks of Apple Inc.

3.     Android and Google Play are trademarks of Google Inc.

 


New Vigilant™ Diabetes Management Companion Launched in U.S. That Alerts Users to Risk of Severe Hypoglycemia in Next 24 Hours

Mobile Technology That Analyzes Patterns of Blood Glucose and Provides Glanceable Control Summaries is Free for a Limited Time

Charlottesville, VA -- InSpark Technologies, Inc., a leader in diabetes pattern recognition technology, today announced that Vigilant is now available for download to compatible smartphones in the United States, and will be free for a limited time and limited number of users. Vigilant is a companion to episodic diabetes monitoring that analyzes patient blood glucose data and provides feedback about daily patterns of highs, lows, glucose variability (frequent swings) and test frequency, as well as patterns indicative of increased risk of severe hypoglycemia in the next 24 hours.  Hypoglycemia results in 280,000 emergency room visits a year in the United States, and is one of the greatest fears for people using Insulin.

Vigilant is the culmination of well over 10 years of work by leading scientists and engineers at the University of Virginia and InSpark Technologies to develop pattern recognition tools that can help with daily diabetes management decisions. There are over 20 peer-reviewed medical journal articles that support the scientific basis of InSpark’s pattern recognition algorithms, their evaluation in large and diverse diabetes population datasets, or report on clinical studies where algorithmic feedback is given to users.

“We couldn’t be more excited about bringing Vigilant to the diabetes community,” said Erik Otto, President and Co-Founder of InSpark, who also has Type 1 diabetes. “Now you don’t have to be encumbered by looking at detailed data logs and charts. Vigilant can analyze your data to give important insights about upcoming periods of risk when you test, because we know that is when you are making diabetes management decisions.”

There are several ways you can use Vigilant:

·      For people with diabetes: 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 Store and Google Play store for download to compatible smartphones.

·      For clinicians and caregivers: A dedicated web-based caregiver version (“Vigilant Caregiver”) is available for those who assist in the care of people with diabetes.  This way clinicians, spouses or parents can also know about their patient or loved one’s patterns and risks, at a glance.

·      Meter compatibility:  For people with compatible phones, Vigilant can also be connected with the Accu-Chek® Aviva Connect blood glucose meter so that data can be wirelessly sent to Vigilant when the user is testing.  More information on meter compatibility can be found here.

For more information or to subscribe go to vigilant.insparktech.com

“We are confident that Vigilant will make a difference in the lives of people with diabetes and their families,” said Laurel Fuqua, Sr. VP of Clinical Affairs for InSpark Technologies. “Vigilant has an advantage over many of the technologies today because it provides powerful insight while not imposing additional burdens on the user’s diabetes routine. It is also complementary to other diabetes management software and monitoring tools such as Continuous Glucose Monitoring (“CGM”).  For example, one way to mitigate a period of risk identified by Vigilant could be to put on a CGM device.”

Today InSpark also announced the formation of its Thought Leadership Council to help guide the launch of Vigilant and future innovation, with six key appointments of leading diabetes experts:  Timothy Bailey, MD, David Marrero, PhD., Anne Peters, MD, Gary Scheiner, MS, Robert Tanenberg, MD and Hope Warshaw, MS, RD.  More information about InSpark’s Thought Leadership Council can be found here.

For more information, you can also read InSpark Founder Erik Otto’s Letter to the Diabetes Community, or view InSpark’s quirky video about how Vigilant can cut through diabetes data smog, alerting you in advance of periods of risk.

 

About Diabetes and Hypoglycemia

More than 29 million people have diabetes in the United States. Diabetes management can be a difficult balancing act, particularly for those on insulin therapy who are continually challenged to maintain near normal blood glucose levels without frequent hypoglycemia. While some patients can experience warning signs before a hypoglycemic event (such as feeling shaky, sweating, tingling in the lips), others may not experience any warning signs. The onset of hypoglycemia can happen suddenly (in minutes) and if not corrected, severe hypoglycemia can result, which may require medical intervention.

 

About InSpark Technologies

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 people with diabetes and their 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 Dr’s Boris Kovatchev, Daniel Cox and Marc Breton, and licensed from the University of Virginia Licensing and Ventures Group.  More information can be found at http://insparktech.com.

 

1.   Vigilant is a trademark of InSpark Technologies, Inc.

2.     Apple and App Store are trademarks of Apple Inc.

3.     Google and Google Play are trademarks of Google Inc.

4.     Accu-Chek ® Aviva Connect is a trademark of Roche Inc.

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Media Contact: Diane Johnson, diane@insparktech.com, 703-203-7746

 

InSpark Technologies Appoints Diabetes Experts to Inaugural Thought Leadership Council

Council to provide input as InSpark Technologies launches its flagship product in the United States

Charlottesville, VA -InSpark Technologies, a leader in diabetes advanced pattern recognition technology, today announced the formation of its Thought Leadership Council with six key appointments of leading diabetes experts:  Timothy Bailey, MD, David Marrero, PhD, Anne Peters, MD, Gary Scheiner, MS, Robert Tanenberg, MD and Hope Warshaw, MS, RD.  

The Thought Leadership Council will work closely with the InSpark Technologies management team as it launches its lead product, Vigilant, a companion to regular diabetes monitoring, which is now available for download in the Apple App Store and Google Play store.  Enabled by advanced pattern recognition technology, Vigilant can provide people with diabetes with glanceable summaries of their glucose control and alert them to high-risk periods on compatible smartphones. For example, Vigilant can alert people when they are at increased risk of severe hypoglycemia in the next 24 hours. InSpark believes that Vigilant has the potential to transform the diabetes data analysis standard of care in the more than 10 million people with diabetes worldwide who take multiple injections of insulin each day or who use insulin pumps.

"The formation of our Thought Leadership Council underscores our commitment to ensuring that our products are meeting the needs of individuals with diabetes and their clinicians,” said Erik Otto, president and co-founder of InSpark Technologies. "It is important to us that our Thought Leadership Council be representative of individuals with diabetes, certified diabetes educators, physicians specializing in diabetes and experienced diabetes researchers. The background and experience of our Thought Leadership Council members is going to be invaluable as we not only move Vigilant forward into nationwide launch, but also as we develop additional technology solutions for people with diabetes."

Timothy Bailey, MD is the President and Director, AMCR Institute, Escondido, CA.  Dr. Bailey is a clinical associate professor of medicine at the University of California at San Diego. He is the immediate past president of the California chapter of American Association of Clinical Endocrinologists (AACE).  Dr. Bailey has extensive experience in medical device trials, including diabetes management software.

David Marrero, PhD is the J.O. Ritchey Professor of Medicine at Indiana University and Director of the Indiana University Diabetes Translational Research Center, Indianapolis, IN. Dr. Marrero is an expert in the field of clinical trials in diabetes and translation research and has lived with type 1 diabetes for 40 years.  In 2015 he was elected American Diabetes Association (ADA) President, Health Care & Education on its Board of Directors.

Anne Peters, MD is the Director, USC Clinical Diabetes Programs and Professor, Keck School of Medicine of USC, Los Angeles, CA.  Dr. Anne L. Peters is a nationally and internationally respected diabetologist and diabetes researcher with multiple NIH and foundation grants, and author of many publications, including the ADA position statements on the treatment of hyperglycemia in type 2 diabetes as well as on the treatment of type 1 diabetes across the lifespan.

Gary Scheiner, MS, CDE, is the Owner & Clinical Director of Integrated Diabetes Services, Wynnewood, PA.  Mr. Scheiner has been a certified diabetes educator for 20 years and has had type 1 diabetes for 35 years. He was named 2014 Diabetes Educator of the Year by the American Association of Diabetes Educators.  Mr. Scheiner serves on the faculty of Children With Diabetes and the Board of Directors of the Juvenile Diabetes Research Foundation (JDRF).

Robert Tanenberg, MD is a Professor of Medicine, Division of Endocrinology, Brody School of Medicine, East Carolina University (ECU) in Greenville, North Carolina.  Dr. Tanenberg directs the ECU Diabetes Research Center where has been a principal investigator for over 60 diabetes research studies.  He has over 35 years’ experience in the management of type 1 diabetes.  He was formerly on the faculty of Georgetown University and was a consultant to the NIH for the landmark Diabetes Control and Complications Trial. 

Hope Warshaw, MMSc, RD, CDE, owns Hope Warshaw Associates, LLC.  Hope has been a dietitian and certified diabetes educator for nearly forty years. Ms. Warshaw has authored numerous consumer and professional focused books published by American Diabetes. She is a writer and contributing editor for Diabetic Living magazine and writes The Washington Post Nutrition Q&A column. During 2016 Warshaw is serving as President of the American Association of Diabetes Educators.

“I am thrilled to join these other leading experts in diabetes to support InSpark,” commented Bob Tanenberg, MD.  “Importantly, the formation of the Thought Leadership Council serves as an endorsement for the scientific and clinical communities enthusiasm for Vigilant and more broadly the company’s unique advance pattern recognition technology platform.”

"Having lived with diabetes myself for 35 years and working as a diabetes educator, I know first hand of the need for innovative technologies that are easy to use and yet provide meaningful insights to people with diabetes,” said Gary Scheiner. “Technology like Vigilant can have a significant impact on the quality of life of people living diabetes. I am honored to participate on this Council.”

About Diabetes

Diabetes affects over 21.9 million Americans, and low blood sugar – or hypoglycemia – is a common and major complication of the disease. According to the American Diabetes Association, it accounts for over 282,000 emergency room visits per year. It annually affects up to 30 percent of individuals with type 1 diabetes, the rarer form in which an individual must rely on insulin treatment because their pancreas doesn’t produce enough insulin to regulate their blood glucose levels.

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 and Ventures Group. More information can be found at http://insparktech.com and http://vigilant.insparktech.com. Follow us on twitter at @insparktech.

1.   Vigilant is a trademark of InSpark Technologies, Inc.

2.     Apple and App Store are trademarks of Apple Inc.

3.     Google and Google Play are trademarks of Google Inc.

# # #

Media Contact: Diane Johnson, diane@insparktech.com, 703-203-7746


InSpark Technologies Presents Study Results Supporting the Utility of Its Hypo Risk Indicator at the Diabetes Technology Meeting

The Hypo Risk Indicator Alerts People With Diabetes to Increased Risk of Severe Hypoglycemia in the Next 24 Hours

Bethesda, MD -- InSpark Technologies, Inc., a leader in diabetes pattern recognition technology, has announced it is presenting a poster at the Diabetes Technology Meeting on October 22 in Bethesda, MD, relating to a study characterizing the utility of its Hypo Risk Indicator for people with diabetes.  The Hypo Risk Indicator alerts people to increased risk of severe hypoglycemia (low blood sugar) in the next 24 hours.  It also includes a list of avoidance options that could help people lessen the risk of a severe low.  The Hypo Risk Indicator is part of a suite of pattern recognition tools included in Vigilant™, a smartphone-based companion to monitoring that alerts people with diabetes in advance of periods of risk and provides glanceable summaries of diabetes control.

To determine the utility of the Hypo Risk Indicator, the study evaluated the relative risk of biochemical severe hypoglycemia (BSH = Blood glucose <40mg/dL) within 24 hours of an alert.  The dataset was comprised of 242,523 readings from 297 patients.  At the medium alert frequency setting, the Hypo Risk Indicator was predictive of 42 percent of all BSHs and was, on average, 7.45 times more likely to be followed by BSH in the next 24 hours compared to baseline.  The Hypo Risk Indicator demonstrated utility across diabetes types and glycemic control cohorts, and also showed advantages versus other potential methods of identifying hypoglycemia risk.

“Unfortunately, hypoglycemia continues to be one of the most challenging problems in diabetes. Frequent hypoglycemic episodes not only negatively impact the quality of life of individuals with diabetes, but also, when severe, can cause seizures, coma, and even death.  The Hypo Risk Indicator can not only be empowering to individuals with diabetes, but can also provide caregivers with valuable insights about patients who are at risk,” said Laurel Fuqua, Sr. VP of Clinical Affairs at InSpark Technologies.

“The Hypo Risk Indicator is only one of many tools in our pattern recognition portfolio that provides people with insights into where their blood glucose may be heading,” added Erik Otto, president and co-founder of InSpark Technologies.  “We believe our Vigilant solution can act as a trusted companion to people with diabetes, alerting them to periods of risk without the need for time-consuming data reviews. We look forward to bringing Vigilant to the diabetes community very soon.” 

 

About InSpark Technologies

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 Dr’s Boris Kovatchev, Daniel Cox and Marc Breton, and licensed from the University of Virginia Licensing and Ventures Group.  More information can be found at www.insparktech.com.  Follow us on twitter at @insparktech.

 

About Vigilant™

Vigilant™† is a companion to 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.  It is designed to provide concise messages prior to periods of risk so that users can take action to improve their glucose control.  It will be available for individuals with diabetes and caregivers on Apple and Google Play App stores for download to smartphones.  Go to www.vigilant.insparktech.com to find out more about Vigilant and to get on a mailing list for company updates.  Follow us on Twitter at @insparktech.

 

† Vigilant™ is not currently available in the United States.

Media Contact:  Diane Johnson, diane@dtjorg.com, 703-203-7746

InSpark Technologies announces the appointment of Laurel Fuqua, RN, MSN, CMC to the position of Sr. Vice President of Clinical Affairs.

Charlottesville, VA – InSpark Technologies, Inc., a company dedicated to providing real-time, actionable blood glucose insights to diabetes patients and clinicians, is pleased to announce that Laurel Fuqua, RN, MSN, CMC will be joining the company in the position of Sr. Vice President of Clinical Affairs, effective June 29th, 2015. At InSpark, Laurel will be responsible for leading clinician outreach, patient and clinician education, clinical study collaborations and medical affairs.  She will also be supporting product development and marketing efforts.  

Ms. Fuqua is an accomplished health care industry innovator with over 20 years of hands-on operational, product marketing, clinical, new business model development and executive leadership experience in chronic disease management and care coordination. She has won several awards for her work in diabetes care and health care services delivery, including being named AADE Diabetes Educator of the Year early in her career.

“We are delighted that Laurel will be joining us as we prepare for the launch of Vigilant™† and plan to more actively engage with clinical and patient stakeholders.  Laurel’s wealth of experience will also help us further enhance and generate awareness of the scientific and clinical support for our pattern recognition technology,” said Erik Otto, President and Co-Founder of InSpark.

“I am very excited and honored to be joining the InSpark team,” said Ms. Fuqua. “With the launch of Vigilant™†, the company has the opportunity to make a significant difference in the lives of people living with diabetes. Today’s diabetes landscape has a growing number of solutions for data capture but there is a need for reliable patient-centered tools for analysis and use of that data. The company’s easy-to-use technology will go a long way in empowering people with diabetes to make decisions that can improve their health and wellbeing.”

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) rather than requiring users to extract insights from detailed charts, graphs and log books. InSpark’s technology is derived from a broad suite of pattern recognition intellectual property licensed from the University of Virginia Licensing and Ventures Group. More information can be found at www.insparktech.com.  

About Vigilant™

Vigilant™† is a mobile health software solution 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.  It is designed to provide concise messages prior to periods of risk so that users can take action to improve their glucose control.

† Vigilant™ is an investigational use software device that is not currently available for sale in the United States.

Study of InSpark Technologies’ Pattern Identification System Published in the Journal of Diabetes Science and Technology

FOR IMMEDIATE RELEASE

 

Study of InSpark Technologies’ Pattern Identification System Published in the Journal of Diabetes Science and Technology

Data demonstrates the utility of InSpark’s advanced blood glucose pattern recognition technology.

CHARLOTTESVILLE, Va. (July 7th, 2014) InSpark Technologies, Inc. announced today that the peer-reviewed Journal of Diabetes Science and Technology has published the paper “Evaluation of the Utility of a Glycemic Pattern Identification System” in its July 2014 issue.  The system that is the subject of this paper is being incorporated into InSpark’s Vigilant™† iPhone-enabled diabetes management software.

The retrospective study evaluated the Vigilant™ daily pattern identification system in data from 536 patients with diabetes. It was found that patterns identified by Vigilant™ algorithms were predictive of future hyperglycemia and hypoglycemia across diabetes types and glycemic control groups, and were significantly more predictive than six other pattern identification techniques evaluated. Episodes of hypoglycemia, hyperglycemia, severe hypoglycemia, and severe hyperglycemia were 120 percent, 46 percent, 123 percent and 76 percent more likely in the next seven days after pattern identification, respectively, compared to intraday periods when no pattern was identified. Identified patterns continued to be predictive of glycemic events up to three months later.

“This is a significant validation of our technology platform,” said Erik Otto, president and co-founder of InSpark Technologies. “An important measure of the utility of identified blood glucose patterns is the degree to which they are indicative of your risk of upcoming high or low blood glucose events. In this study we have shown that our pattern messages are not only highly predictive of future glycemic events, but more so than common ways glucose patterns are identified today. We are excited about bringing this technology to patients and clinicians so they can benefit from this pattern information to improve diabetes management.”

"There are now many ways patients can transmit readings to mobile phones or cloud-based systems, but unfortunately little value is added to that data in terms of concise summaries or prospective actionable messages about glucose patterns,” said Dr. Stacey Anderson, medical director at the University of Virginia Center for Diabetes Technology. “As shown by these study results, InSpark is taking a leadership role in transforming blood glucose data into relevant information that can empower patients and clinicians to make better diabetes management decisions in real-time."

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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 pushes actionable pattern-related information to patients and health care providers at the time they need it most (such as when a patient is testing) rather than requiring them to pull the information from detailed charts, graphs, and log books. InSpark’s technology is derived from a broad suite of pattern recognition intellectual property licensed from the University of Virginia Licensing and Ventures Group.  More information can be found at www.insparktech.com.  

 

About Vigilant

Vigilant™† is an iPhone-enabled software device 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.  It is designed to provide concise messages prior to periods of risk so that users can take action to improve their glucose control.

 

† Vigilant™ is an investigational use software device that is not currently available for sale in the United States.

 

Contact:

Marijean Jaggers

Jaggers Communications

mjaggers@jaggerscommunications.com

636.485.2920

InSpark Provides Update on Recent FDA Meeting

FOR IMMEDIATE RELEASE

 

InSpark Technologies Announces FDA Progress in Bringing VigilantDiabetes Management Software to the Marketplace

Meeting supports clear path to commercialization

 

CHARLOTTESVILLE, Va. (May 12, 2014) InSpark Technologies, Inc. announced today the results of a recent meeting with the FDA regarding the development and regulatory strategy for Vigilant† diabetes management software. Vigilant is an iPhone-enabled software application 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.  It is designed to provide concise messages prior to periods of risk so that users with diabetes can take action to improve their glucose control.

 

The FDA cited no significant concerns with a comprehensive package of completed and planned future studies, performance assessments for Vigilant’s three principal pattern recognition algorithms and validation plans for the software system. Furthermore, the FDA was aligned with InSpark’s perspective on the level of patient risk associated with the software system.

 

“We are delighted that in this meeting we had a similar view on patient-related risks for our software, and we are encouraged by the FDA’s feedback on our comprehensive development plan,” said Erik Otto, president and co-founder of InSpark. “This feedback gives us confidence in being able to deliver the benefits of Vigilant’s advanced pattern recognition technology to patients and clinicians in a reasonable timeframe.”

 

Diane Horwitz, PhD, RAC, regulatory affairs consultant to InSpark Technologies said, “This is a testament to the work InSpark has done to create a well-thought out development plan that addresses patient safety and the user’s interaction with their pattern analysis algorithms. It will be exciting to see people benefiting from the actionable information provided by Vigilant soon.”

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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 pushes actionable pattern-related information to patients and health care providers at the time they need it most (such as when a patient is testing) rather than requiring them to pull the information from detailed charts, graphs, and log books. InSpark’s technology is derived from a broad suite of pattern recognition intellectual property licensed from the University of Virginia Licensing and Ventures Group.  More information can be found at www.insparktech.com.  

 

About Vigilant

Vigilant™ is an iPhone-enabled software device 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.  It is designed to provide concise messages prior to periods of risk so that users can take action to improve their glucose control.

 

† Vigilant™ is an investigational use software device that is not currently available for sale in the United States.

 

Contact:

Marijean Jaggers

Jaggers Communications

mjaggers@jaggerscommunications.com

636.485.2920