May 05,2023

Study supports feasibility of Know Labs non-invasive CGM

Know Labs (NYSE:KNW) today announced the results of a feasibility study comparing its glucose monitoring technology to the Dexcom G6 CGM. It’s presenting results today at the American Association of Clinical Endocrinology (AACE) Annual Meeting in Seattle. The company sought to validate the technical feasibility of its Bio-RFID sensor technology for quantifying blood glucose concentration (BGC). Its studies evaluated five healthy participants using the Dexcom G6 as a reference device. Participants placed their forearms on the Bio-RFID sensor and consumed liquid D-Glucose to stimulate a glucose spike. The study monitored BGC for three hours while simultaneously logging readings from the Bio-RFID sensor and the Dexcom G6. It collected data on a continuous basis. Know Labs then used the data from the Bio-RFID sensor to train the neural network model to predict the readings. Know Labs said its study resulted in a mean absolute relative difference (MARD) of 20.6%. It performed with 46% of predictions within the FDA’s recommended limit for accuracy for new blood glucose monitors.

CLINICAL STUDY

#cgm

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May 05,2023

Insulet Announces New Organizational Structure to Drive Further Growth

Insulet Corporation the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced its new organizational structure designed to accelerate innovation and commercialization. The new structure will be implemented during the second half of this year with new leadership roles effective July 1, 2023. As part of the new organizational structure, we have created the following roles, effective July 1, 2023: Eric Benjamin has been named Chief Product & Customer Experience Officer (CPXO), responsible for product vision and execution; Mark Field has been named Chief Technology Officer, responsible for software and hardware engineering, information technology; Patrick Crannell will continue in his role as International General Manager overseeing the Company’s international commercial operations. The Company has commenced a search for a U.S. General Manager, who will focus on accelerating our U.S. commercial growth, go-to-market strategies, and sales operations.

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May 02,2023

DarioHealth Announces $14.3 Million Private Placement

DarioHealth Corp. announced the pricing of a $14.3 million private placement of convertible preferred stock, priced at the market under Nasdaq rules, with significant participation by select members of leadership, the Board and existing investors.

FUNDING POST-IPO EQUITY
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May 02,2023

Hygieia Extends Series B Round to $22 Million with Participation from Strategic Investors

Hygieia, a digital therapeutics company for insulin therapy, is extending its Series B funding round to $22 million with a lead investment from Firstime Ventures and additional investment from two strategic partners.

FUNDING SERIES B
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May 02,2023

Contributor: CMS Has Decided to Put Its Muscle Behind Glycemic Management—Why Now?

Properly managing blood glucose is complex and needs to be personalized for every patient based on their insulin sensitivity, caloric intake, and a number of other fluctuating patient-specific factors. As a result, most hospitals struggle to adequately manage their patients’ blood sugars given their reliance on manual or simplistic protocols. Across the 6000 hospitals in the United States, many clinicians still calculate insulin doses manually, using tools like paper protocols or digitized calculators built into electronic medical records that are simple but cannot provide personalized recommendations for each patient. These protocols require multiple steps or calculations, which often lead to dosing errors. These methods are a big part of the reason that insulin is involved in 16.3% of medication error reports for high-alert medications in acute care settings, more than any other medication type. These new CMS glycemic management measures finally answer the calls the ADA and others like National Quality Forum (NQF) have been making for 2 decades to hold hospitals to the standards of care for glycemic management.

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May 02,2023

Dexcom proposes $1B offering of convertible senior notes

Dexcom (Nasdaq:DXCM) today announced that it intends to offer $1 billion in convertible senior notes due in 2028. The continuous glucose monitor (CGM) maker made its private placement to persons reasonably considered qualified institutional buyers.

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Apr 28,2023

Abbott FreeStyle Libre 3 authorized for automated insulin delivery in UK

Abbott announced that its FreeStyle Libre 3 continuous glucose monitor (CGM) received UK authorization for use in automated insulin delivery. Authorization enables FreeStyle Libre 3 — Abbott’s newest sensor — to work with the Ypsomed mylife YpsoPump and CamDiab’s CamAPS FX mobile app. The company called this a “major step forward” for type 1 diabetes management in the United Kingdom.

PRODUCT

#cgm

#closed loop

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Apr 27,2023

Dexcom Reports First Quarter 2023 Financial Results

DexCom, Inc. (Nasdaq: DXCM) today reported its financial results as of and for the quarter ended March 31, 2023. In the first quarter of 2023, worldwide revenue grew 18% to $741.5 million on a reported basis, up from $628.8 million in the first quarter of 2022. U.S. revenue growth of 17% and international revenue growth of 21% on a reported basis. International revenue growth was 27% on an organic basis.

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Apr 27,2023

Dexcom G6 Real-Time CGM System Now Accessible to Any Eligible Client Managing Diabetes With Insulin Through NIHB

Dexcom applauds the progressive expansion of coverage for continuous glucose monitoring systems through the Non-Insured Health Benefits (NIHB) program. Dexcom G6 is now at its most accessible point ever under the NIHB program, making the highest degree of diabetes management possible for First Nations and Inuit peoples. Having more choice to use Dexcom CGM is pivotal, and this expansion brings people in Canada one step closer to accessing the technology they need.

PRODUCT

#cgm

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Apr 27,2023

Go-ahead for a new Ypsomed production facility in China

Ypsomed has already been supplying products such as the reusable ServoPen to China for over 15 years. In the future, pharmaceutical companies will also increasingly use disposable products in China, such as the UnoPen or the YpsoMate. Business with disposables is more volume-intensive, which is why the proximity of production to the place of delivery is sought.

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