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Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced publication by the New England Journal of Medicine (NEJM) of results from the Protocol 5 study (DCLP5) of the International Diabetes Closed Loop (iDCL) trial. Results demonstrated increased time spent in range (70-180 mg/dL) in children ages 6 to 13 years old using the t:slim X2™ insulin pump with Control-IQ™ advanced hybrid closed-loop technology. The article was published on August 27, 2020 and is available on the journal website, www.NEJM.org.
The DCLP5 study was the first-ever large-scale, closed-loop pediatric study that included a dedicated control group. Over the four-month study period, use of Control-IQ technology led to a higher percentage of time spent in range (70-180 mg/dL) and less hyperglycemia than the control group. The control group used either a sensor augmented pump without automated insulin dosing or Tandem’s t:slim X2 pump with Basal-IQ® predictive low glucose suspend technology. No severe hypoglycemia or diabetic ketoacidosis was reported, and 100 percent of participants using Control-IQ technology completed the study.
"We are thrilled with the benefits observed in this study in school-aged children with type 1 diabetes, a population that often struggles with diabetes management for a variety of reasons,” said Dr. R. Paul Wadwa, Professor of Pediatrics, at the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, and the protocol chair for this trial. "Control-IQ technology proved very easy to use for children and their parents and led to improved glucose control during both the day and night.”
"After the resounding success of the system in adolescents and adults in the previous DCLP3 study, it is very rewarding to see younger participants in the DCLP5 benefit as well, and to the same extent,” said Dr. Marc Breton, the Associate Director for Research of The Center for Diabetes Technology at the University of Virginia, and the Principal Investigator of the DCLP5 study. "We are excited to see the results of 15 years of research acknowledged once more by NEJM.”
The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 continuous glucose monitoring (CGM) sensor values to predict glucose levels 30 minutes ahead and adjust insulin delivery to help prevent highs and lows, while still allowing the user to manually bolus for meals. The system also delivers automatic correction boluses, a first for commercial automated insulin delivery systems. The t:slim X2 insulin pump with Control-IQ technology, originally approved for ages 14 and older, received U.S. Food and Drug Administration clearance for use in ages six and older in June 2020. The t:slim X2 pump with Control-IQ technology also recently launched in select geographies outside the United States.
"The safety and efficacy data from the DCLP5 study featured in this NEJM publication, coupled with the positive experiences reported to us by younger Control-IQ users and their families, exemplifies our commitment to our mission to improve the lives of people with diabetes,” said John Sheridan, president and CEO of Tandem Diabetes Care.
"The integration of Control-IQ technology with Dexcom G6 has proven to be an incredibly effective combination for automated insulin delivery. We are thrilled with the pediatric results published today and proud of the role Dexcom played in the DCLP5 study,” said Kevin Sayer, chairman, president and CEO of Dexcom.
Key Data Highlights
Glycemic Control over Four Months
Time in range (70 mg/dL – 180 mg/dL) increased from 53 percent at baseline to 67 percent in participants using Control-IQ technology, the equivalent of 3.4 more hours per day. The control group demonstrated an increase from 51 percent to 55 percent.
Time in range at night (midnight to 6:00 a.m.) was 80 percent using Control-IQ technology compared to 54 percent in the control group.
Mean glucose was significantly lower in participants using Control-IQ technology (162 vs. 179 in the control group, p
NEW YORK, May 2, 2021 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against 3D Systems Corporation ("3D Systems" or the "Company") (NYSE: DDD) and certain of its officers. The class action, filed in the United States District Court for the Eastern District of New York, and docketed under 21-cv-02383, is on behalf of a class consisting of all persons and entities other than Defendants who purchased or otherwise acquired the publicly traded securities of 3D Systems from May 7, 2020 to March 1, 2021 (the "Class Period"). Plaintiff seeks to recover compensable damages caused by Defendants' violations of the federal securities laws under the Securities Exchange Act of 1934 (the "Exchange Act").If you are a shareholder who purchased 3D Systems securities during the Class Period, you have until June 8, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action]3D Systems provides comprehensive 3D printing and digital manufacturing solutions, including 3D printers for plastics and metals, materials, software, on-demand manufacturing services, and digital design tools.
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) 3D Systems lacked proper internal controls over financial reporting; and (ii) as a result, 3D Systems' public statements were materially false and/or misleading at all relevant times.On March 1, 2021, 3D Systems issued a press release announcing a delay of filing the Company's 10-K annual report for the fiscal year ended December 31, 2020, noting that "the delay in filing is primarily related to the presentation of cash flows associated with the divestiture process for its Cimatron and GibbsCam software businesses," while revealing that the Company had "discovered certain internal control deficiencies" and "will report material weaknesses in internal controls in its fiscal 2020 Annual Report on Form 10-K."On March 2, 2021, 3D Systems filed a Form NT 10-K with the United States Securities and Exchange Commission, stating that the Company's 10-K filing would be delayed for the reasons listed in its March 1, 2021 press release.On this news, 3D Systems' stock price fell $7.62 per share, or more than 19.6%, from closing at $38.79 per share on March 1, 2021 to close at $31.17 per share on March 2, 2021, damaging investors.The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
CONTACT: Robert S. WilloughbyPomerantz LLP email@example.com ext. 7980 View original content to download multimedia:https://www.prnewswire.com/news-releases/shareholder-alert--pomerantz-law-firm-reminds-shareholders-with-losses-on-their-investment-in-3d-systems-corporation-of-class-action-lawsuit-and-upcoming-deadline--ddd-301281765.htmlSOURCE Pomerantz LLP