Tag: Diabetes
Dexcom U returns for fourth season
April 24, 2025HME News Staff
SAN DIEGO – Dexcom is bringing back Dexcom U, a name, image and license program for college athletes with diabetes. This year, the fourth for the program, includes a nationwide open call for passionate and inspiring college athletes to join its roster. Now through May 23, athletes, coaches, friends and family members can nominate candidates through an online submission. The nomination criteria used by the selection committee are focused on seeking college athletes with diabetes who are passionate...
Medtronic seeks FDA clearance for pump
April 24, 2025HME News Staff
GALWAY, Ireland – Medtronic has submitted 510(k) applications to the U.S. Food and Drug Administration seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform. The submissions included a 510(k) application for its MiniMed 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard...
Aeroflow Health builds out diabetes offerings
April 23, 2025HME News Staff
ASHEVILLE, N.C. – Aeroflow Health has launched its Comprehensive Diabetes Management Program, an integrated, multimodal support program that provides patients with the tools and resources to manage their glucose levels.
The program incorporates a Diabetes Self Management Education (DSME) system designed to provide patients with medication adherence, lifestyle modifications, and glucose monitoring strategies, along with a digital tool to help patients derive meaningful insights from...
In brief: Numotion reports data incident, Abbott launches app
April 23, 2025HME News Staff
PHOENIX - Numotion recently learned that certain employee email accounts were accessed without authorization on several occasions between Sept. 2, 2024, and Nov. 18, 2024, the company said in a Notice of Data Security Incident posted on its website.
In the notice, the company states: “Numotion has no reason to believe that anyone was trying to access personal information in the accounts, and there is no indication that any information has been used for fraud or identity theft....
Medtronic sensor receives FDA clearance
April 22, 2025HME News Staff
GALWAY, Ireland – Medtronic has received clearance from the U.S. Food and Drug Administration for the Simplera Sync sensor for use with the MiniMed 780G system. With this approval, the MiniMed 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection technology with both the Guardian 4 sensor and Simplera Sync sensor. The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard...
Abbott seeks to go ‘above the bias’
March 28, 2025Theresa Flaherty, Managing Editor
ALAMEDA, Calif. – Nearly 70% of people with diabetes believe there is stigma associated with their condition, according to a survey from Abbott, and that can stand in the way of care, says Dr. Mahmood Kazemi.
“Misconceptions and stereotypes about diabetes can prevent some people from getting care,” said Kazemi, divisional vice president, medical/clinical affairs and chief medical officer, Abbott Diabetes Care. “It’s disheartening. What is promising, though,...
FDA issues warning to Dexcom
March 27, 2025HME News Staff
SAN DIEGO – Dexcom has received a warning letter from the U.S. Food and Drug Administration regarding “non-conformities” in manufacturing and quality processes after inspections of its facilities in Sad Diego and Mesa, Ariz. In a form 8-K filed with the U.S. Securities and Exchange Commission, the company said it takes the matters identified in the warning letter seriously, has already submitted several responses to Form 483 and is in the process of preparing a written response...
DMEs improve adherence, lower costs & reduce utilization, study finds
March 25, 2025HME News Staff
DALLAS – There are significant advantages for patients receiving continuous glucose monitors through DME providers compared to pharmacies, including higher adherence rates, according to a new study published in Clinical Diabetes, a peer-reviewed journal of the American Diabetes Association.
The study, supported by CCS, demonstrates that efforts to expand access to CGMs by adding pharmacy as a new channel for distribution — alongside the established DME provider channel —...
‘Now is the time to push for greater investment in CGM tech,’ report finds
March 24, 2025HME News Staff
EDINBURGH, Scotland, and SAN DIEGO – Tech, not medicine, is the future of care for Type 2 diabetes patients, according to a new report from Dexcom.
Fifty-two percent of health care professionals ranked access to continuous glucose monitors and education as having the potential to positively help people with Type 2 manage their condition in the next 10 years compared with 30% who cited better or more effective medications.
“With policymakers increasingly focused on digital...
DME providers can help physicians manage diabetes population, study finds
March 21, 2025Theresa Flaherty, Managing Editor
DALLAS – The No. 1 reason physicians cite for not prescribing a continuous glucose monitor is its complexity, a roadblock that DME providers can help clear, according to a new study from CCS.
That complexity, along with a surge in the number of diabetes patients, leaves primary care physicians and endocrinologists feeling overwhelmed and not able to keep up-to-date on technology, and, ultimately, struggling to offer enough health coaching and education to their patients. That creates...