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News Article | February 15, 2017
Site: www.eurekalert.org

Clinical trials are now enrolling to provide the final tests for a University of Virginia-developed artificial pancreas to automatically monitor and regulate blood-sugar levels in people with type 1 diabetes. Participants in the trials will live at home and follow their regular routines to examine how well the device works in real-life settings. The studies will examine several factors, including safety, effectiveness and cost as well as the physical and emotional health of trial participants. If the clinical trials produce favorable findings, the results could lead to applications to the U.S. Food and Drug Administration and other regulatory groups to approve the device for use by people with type 1 diabetes, whose bodies do not produce enough insulin. The goal of the artificial pancreas is to eliminate the need for people with type 1 diabetes to stick their fingers multiple times daily to check their blood-sugar levels and to inject insulin manually. The artificial pancreas is designed to oversee and adjust insulin delivery as needed. It uses a platform called InControl developed by TypeZero Technologies, a Charlottesville startup company that licensed the UVA system. The platform features a reconfigured smartphone running advanced algorithms that is linked wirelessly to a blood-sugar monitor and an insulin pump that the patient wears, as well as a remote-monitoring site. Artificial pancreas users can also access assistance via telemedicine. "With the artificial pancreas, we are seeking to create a networked digital treatment framework for people with type 1 diabetes that is adaptable to their needs," said UVA's Boris Kovatchev, PhD, the co-principal investigator of the trials along with UVA Health System endocrinologist Stacey Anderson, MD. Kovatchev is also a co-founder of TypeZero Technologies and serves as chief mathematician for the company. The first trial will follow 240 people ages 14 and older for six months to examine technology developed at the UVA Center for Diabetes Technology and further refined for clinical use by TypeZero Technologies. The second trial will recruit U.S. participants from the first trial to test a new control algorithm developed by the team of Dr. Francis Doyle III at the Harvard John A. Paulson School of Engineering and Applied Sciences to determine whether it further improves blood sugar control. The trials are being funded through a grant (No. DK108483) of more than $12.6 million from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health. "Managing type 1 diabetes currently requires a constant juggling act between checking blood glucose levels frequently and delivering just the right amount of insulin while taking into account meals, physical activity, and other aspects of daily life, where a missed or wrong delivery could lead to potential complications," said Dr. Andrew Bremer, the NIDDK program official overseeing the artificial pancreas trials. "Unifying the management of type 1 diabetes into a single, integrated system could lift so much of that burden." Learn more about the artificial pancreas trials at Clinicaltrials.gov: NCT02985866 and NCT02844517.


SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, Dexcom, Inc. (NASDAQ: DXCM), a leader in continuous glucose monitoring (CGM) for people with diabetes, and TypeZero Technologies, LLC, a digital health and personalized medicine company, today announced that they are working together on the integration of their technologies into the NIH-funded International Diabetes Closed Loop (IDCL) Trial starting later this year. A Tandem insulin pump and Dexcom G5 sensor will be included as part of a blood glucose control system that combines these devices with a smartphone running TypeZero’s inControl closed loop algorithm. The system predicts high and low blood sugar levels and adjusts insulin delivery accordingly throughout the day, while still allowing the user to manually bolus for meals. In addition to basal insulin adjustments, TypeZero’s inControl system also automates correction boluses. Tandem and Dexcom anticipate adding a Dexcom G6 sensor-integrated t:slim X2 Pump that incorporates inControl’s algorithms directly into the pump’s touchscreen interface to the IDCL Trial in 2017. The companies anticipate that the integrated design, together with data from the IDCL Trial, will be the basis for a future regulatory submission by Tandem. “The IDCL Trial is designed as a pivotal trial of a closed-loop control-to-range system, and includes seven institutions in the U.S. and three in Europe led by the University of Virginia,” said Boris Kovatchev, PhD, Director of the Center for Diabetes Technology at the University of Virginia and principal investigator of the IDCL Trial. “The integration of technology provided by Tandem, Dexcom, and TypeZero in this trial represents a new level of sophistication in artificial pancreas research and development.” “A world-class automated insulin delivery system needs to be simple to use, rely on the most accurate CGM data available, and use a proven and trusted algorithm,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “We believe the combination of Tandem, Dexcom, and TypeZero technologies will deliver all three, and we are honored to be working together with them for this trial.” "Our efforts with Tandem began with the display of CGM data on their t:slim G4 Pump and we are pleased to take this next step in the integration of our future products to support automated insulin delivery," said Steve Pacelli, EVP, Strategy & Corporate Development at Dexcom. “The addition of Tandem’s innovative touchscreen pumps to the IDCL Trial is tremendous, and a great first step in their integration of our inControl algorithm into a future software update for the t:slim X2 Pump,” said Chad Rogers, Chief Executive Officer at TypeZero Technologies. “We look forward to bringing these solutions to patients in the upcoming IDCL trial and ultimately delivering a best-in-class automated insulin delivery solution to patients across the globe.” The IDCL Trial is expected to enroll 240 adults with type 1 diabetes and is projected to start in late 2016. TypeZero’s technology includes a series of algorithms developed from initial research conducted at the University of Virginia. To date, this technology has been used in more than 28 clinical studies including more than 475 participants, with data referenced in a number of journal articles.1 Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with diabetes who use insulin. The Company manufactures and sells the t:slim X2™ Insulin Pump, the slimmest and smallest durable insulin pump currently on the market, the t:flex® Insulin Pump, the first pump designed for people with greater insulin requirements, and the t:slim G4™ Insulin Pump, the first continuous glucose monitoring-enabled pump with touch-screen simplicity. Tandem is based in San Diego, California. Dexcom, Inc., headquartered in San Diego, CA, is dedicated to helping people better manage their diabetes by developing and marketing continuous glucose monitoring (CGM) products and tools for adult and pediatric patients. With exceptional performance, patient comfort and lifestyle flexibility at the heart of its technology, users have consistently ranked Dexcom highest in customer satisfaction and loyalty. For more information on the Dexcom CGM, visit www.dexcom.com. The world leader in clinically tested artificial pancreas solutions, TypeZero Technologies is a digital health and personalized medicine startup dedicated to revolutionizing the treatment and management of diabetes. TypeZero is combining next-generation data science techniques, proven metabolic models, and modern engineering practices to develop customized analytics tools and blood glucose control solutions to help people with diabetes improve their health and lives. TypeZero’s current products include a smartphone-based Artificial Pancreas system, therapy optimization tools for health care providers, and advisory applications for smart insulin pens. To learn more, visit www.typezero.com. t:slim, t:flex, and Tandem Diabetes Care are registered trademarks, and t:slim X2 and t:slim G4 are trademarks of Tandem Diabetes Care, Inc. Dexcom, Dexcom G5 and Dexcom G6 are registered trademarks of Dexcom, Inc. This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to, among other things, the timing of anticipated enrollment and commencement of the IDCL trial, the use of a Tandem insulin pump and Dexcom G5 sensor as part of a system that combines these devices with a smartphone running TypeZero’s inControl algorithm in the IDCL trial, the current plan to develop and use a Dexcom G6 sensor-integrated t:slim X2 Pump that incorporates the inControl algorithm directly into the pump’s touchscreen interface as part of the IDCL trial in the future and whether the integrated design will be the basis for a future regulatory filing by Tandem. These statements are subject to numerous risks and uncertainties, including the risk that the IDCL trial will be completed as currently contemplated, Tandem’s ability to complete the development of a Dexcom G6 sensor-integrated t:slim X2 that incorporates the inControl algorithm directly into the pump’s touchscreen interface, Dexcom’s ability to secure regulatory approval for the Dexcom G6 CGM and Tandem’s ability to rely on the data from the IDCL trial to support future regulatory filing, as well as other risks identified in Tandem’s or Dexcom’s most recent Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, respectively, and other documents that they file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The companies undertake no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors. 1 Recent Publications Highlighting Research Using TypeZero AP Technology: (a) Ly T, Buckingham B, DeSalvo et al. Day-and-Night Closed-Loop Control Using the Unified Safety System in Adolescents With Type 1 Diabetes at Camp. Diabetes Care 2016 Aug; 39(8): e106-e107. (b) Anderson S, Raghinaru D, Pinsker J, et al. Multinational Home Use of Closed-Loop Control Is Safe and Effective. Diabetes Care. 2016 Jul;39(7):1143-50. (c) Boris P. Kovatchev, Eric Renard, Claudio Cobelli, et al. Safety of Outpatient Closed-Loop Control: First Randomized Crossover Trials of a Wearable Artificial Pancreas. Diabetes Care. 2014 Jul; 37(7): 1789–1796.


Nass R.,University of Virginia | Nikolayev A.,Eli Lilly and Company | Liu J.,University of Virginia | Pezzoli S.S.,University of Virginia | And 6 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2015

Background: Acyl-ghrelin is a 28-amino acid peptide released from the stomach. Ghrelin O-acyl transferase (GOAT) attaches an 8-carbon medium-chain fatty acid (MCFA) (octanoate) to serine 3 of ghrelin. This acylation is necessary for the activity of ghrelin. Animal data suggest that MCFAs provide substrate for GOAT and an increase in nutritional octanoate increases acyl-ghrelin. Objectives: To address the question of the source of substrate for acylation, we studied whether the decline in ghrelin acylation during fasting is associated with a decline in circulating MCFAs. Methods: Eight healthy young men (aged 18-28 years, body mass index range, 20.6-26.2 kg/m2) had blood drawn every 10 minutes for acyl- and desacyl-ghrelin and every hour for free fatty acids (FFAs) during the last 24 hours of a 61.5-hour fast and during a fed day. FFAs were measured by a highly sensitive liquid chromatography-mass spectroscopy method. Acyl- and desacyl-ghrelin were measured in an in-house assay; the results were published previously. Ghrelin acylation was assessed by the ratio of acyl-ghrelin to total ghrelin. Results: With the exception of MCFAs C8 and C10, all other FFAs, the MCFAs (C6 and C12), and the long-chain fatty acids (C14-C18) significantly increased with fasting (P α .05). There was no significant association between the fold change in ghrelin acylation and circulating FFAs. Conclusions: These results suggest that changes in circulating MCFAs are not linked to the decline in ghrelin acylation during fasting and support the hypothesis that acylation of ghrelin depends at least partially on the availability of gastroluminal MCFAs or the regulation of GOAT activity. © 2015 by the Endocrine Society.


Nass R.,Center for Diabetes Technology | Farhy L.S.,Center for Diabetes Technology | Liu J.,Center for Diabetes Technology | Pezzoli S.S.,Center for Diabetes Technology | And 3 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2014

Background: Acyl-ghrelin is thought to have both orexigenic effects and to stimulate GH release. A possible cause of the anorexia of aging is an age-dependent decrease in circulating acyl-ghrelin levels. Objectives: The purpose of the study was to compare acyl-ghrelin and GH concentrations between healthy old and young adults and to examine the relationship of acyl-ghrelin and GH secretion in both age groups. Methods: Six healthy older adults (age 62-74 y, body mass index range 20.9-29 kg/m2) and eight healthy young men (aged 18-28 y, body mass index range 20.6-26.2 kg/m2) had frequent blood samples drawn for hormone measurements every 10 minutes for 24 hours. Ghrelin was measured in an in-house, two-site sandwich ELISA specific for full-length acyl-ghrelin. GH was measured in a sensitive assay (Immulite 2000), and GH peaks were determined by deconvolution analysis. The acyl-ghrelin/GH association was estimated from correlations between amplitudes of individual GH secretory events and the average acyl-ghrelin concentration in the 60-minute interval preceding each GH burst. Results: Twenty-four-hour mean (±SEM) GH (0.48 ± 0.14 vs 2.2 ± 0.3 μg/L, P < .005) and acylghrelin (14.7 ± 2.3 vs 27.8 ± 3.9 pg/mL, P < .05) levels were significantly lower in older adults comparedwithyoungadults. Twenty-four-hour cortisol concentrationswerehigher in the old than the young adults (15.1 ± 1.0 vs 10.6 ± 0.9 μg/dL, respectively, P < .01). The ghrelin/GH association was more than 3-fold lower in the older group compared with the young adults (0.16 ± 0.12 vs 0.69 ± 0.04, P < .001). Conclusions: These results provide further evidence of an age-dependent decline in circulating acyl-ghrelin levels, which might play a role both in the decline of GH and in the anorexia of aging. Our data also suggest that with normal aging, endogenous acyl-ghrelin levels are less tightly linked to GH regulation. Copyright © 2014 by the Endocrine Society.

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