Nov 21,2023 TOP STORY

Kaleido launches cutting-edge Hybrid Closed Loop system with Diabeloop and Dexcom for people with diabetes

ViCentra B.V., the company behind Kaleido, one of the world's smallest, lightest insulin patch pump systems for managing type 1 diabetes, is pleased to announce the launch of a Hybrid Closed Loop system for automated insulin delivery. This system delivers insulin by using the DBLG1 algorithm from Diabeloop, which receives input from the Dexcom G6 Continuous Glucose Monitoring (CGM) sensor. Kaleido users can wear their pump as a patch or place it in their pocket at their own discretion. The system comes with two durable pumps that are rechargeable, eliminating the need to dispose of the pump every 3 days as other patch pumps do. DBLG1 algorithm considers the user's glucose levels provided by the Dexcom G6 Continuous Glucose Monitor (CGM) alongside inputs on meals and activities to determine the insulin delivery. Users and healthcare professionals have real-time access to their data insights via automated transfer to the cloud platform YourLoops. ViCentra is launching the Hybrid Closed Loop system in Germany, the Netherlands and France with its commercial partner Diabeloop. Roll-out to additional countries which include the UK and Italy is planned for 2024.

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Nov 21,2023

Nemaura Medical Inc. Secures $10 Million Non-Dilutive Credit Facility to Fuel Strategic Growth

Nemaura Medical, developer of a daily wear non-invasive glucose sensor, and digital healthcare programs is pleased to announce the execution of a strategic agreement for a $10 million credit facility which is expected to support the Company’s strategic growth plans. Recognizing the challenges associated with equity sales, particularly in the small-cap landscape on the Nasdaq, Nemaura Medical has proactively pursued a funding strategy that minimizes dilution and, the Company believes, aligns with the best interests of its valued shareholders. This $10 million credit facility, structured to be non-dilutive, empowers the Company to draw down a maximum of $1 million per month, providing a steady and controlled infusion of capital to support Nemaura Medical’s commercialization initiatives.

FUNDING NON-DILUTIVE CREDIT FACILITY

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Nov 13,2023

Nemaura Medical Reports Fiscal Second Quarter 2024 Results and Provides Business Update

Nemaura Medical released its financial results for the quarter ended September 30, 2023 and provided a business update. Research and development expenses were reported as $491,803 in this quarter, compared to $257,061 in the same period in 2022. Net loss was around $1.2 million USD for the three months ended September 30, 2023, compared to $3.8 million in the same period last year. During this quarter, the Company continued to support its UK licensee with its endeavours to obtain reimbursement for the sensors in the UK. the Company’s BEATdiabetes offering in readiness for a commercial launch is in due course. Nemaura also received approval from the Saudi Arabia Food and Drug Agency for marketing of sugarBEAT in the Kingdom of Saudi Arabia (KSA), with support from the Company’s licensee in the region, TP MENA.

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Nov 14,2023

Nemaura Launches Direct to Consumer Offering of Metabolic Health Program in Combination with GLP-1 Weight Loss Drugs

Nemaura Medical, developer of a daily wear non-invasive glucose sensor and digital healthcare programs, announced the UK launch of its approach to metabolic health and weight management by integrating CGMs with its behavioral change program, Miboko, complemented by pharmaceutical interventions using GLP-1 agonists such as Ozempic, Wegovy and Mounjaro. Their offering incl. education, lifestyle modifications, dietary guidance, exercise goals, and cutting-edge glucose monitoring, represents a significant advancement in personalized weight loss strategies addressing the metabolic health, obesity and diabetes markets. The goal is to provide individuals with the tools they need to make lasting changes that support their overall well-being. The incorporation of GLP-1 agonists like Ozempic, Wegovy and Mounjaro adds a powerful layer of support for individuals seeking effective and sustainable weight loss.

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Nov 09,2023 TOP STORY

Kakao Healthcare secures deal to distribute Dexcom G7

Kakao Healthcare, the digital arm of South Korean internet company Kakao Corporation, has signed a local sales agreement with pharmaceutical firm Huons to make Dexcom G7 continuous glucose monitors available across South Korea. The sale of the Dexcom G7, which will begin in the first quarter of next year, is part of Kakao Healthcare's initiative to set up a local digital diabetes management service with Dexcom. To recall, the two companies entered into a global collaboration in June 2023.

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Nov 02,2023 TOP STORY

Sibionics wins CE mark for GS1 CGM System

Chinese company Sibionics has obtained a CE Mark for its GS1 continuous glucose monitoring system (CGM), a wearable device that uses an under-the-skin sensor to measure glucose levels in real-time, transmitting the information to a linked handset or mobile phone. The GS1 CGM offers users 14 days of continuous glucose monitoring without the need for frequent calibration. It allows users to transmit glucose data to monitoring devices or mobile apps and generate professional reports.  An additional feature of the system supports data sharing with friends and family and integrates the ProView remote access platform for healthcare providers to monitor and intervene. The GS1 CGM received marketing approval in China in 2021, and the company claims that it is the first blood-glucose meter without the need for finger blood calibration. 

REGULATORY CE MARK

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Oct 30,2023

Glucose Monitoring Metrics in Individuals With Type 1 Diabetes Using Different Treatment Modalities: A Real-World Observational Study

A cross-sectional study at Steno Diabetes Center Copenhagen, Denmark, included individuals with type 1 diabetes using CGM, aimed to investigate the association between continuous glucose monitoring (CGM)-derived glycemic metrics and different insulin treatment modalities using real-world data. Data from September 2021 to August 2022 were analyzed if CGM was used for at least 20% of a 4-week period. Individuals were divided into four groups: multiple daily injection (MDI) therapy, insulin pumps with unintegrated CGM (SUP), sensor-augmented pumps with low glucose management (SAP), and automated insulin delivery (AID). The MDI and SUP groups were further subdivided based on CGM alarm features. The primary outcome was percentage of time in range for each treatment group. The proportion of individuals achieving all recommended glycemic targets was significantly higher in SAP and AID compared with MDI without alarm features. Median TIR was 54.0% for MDI, 54.9% for SUP, 62,9% for SAP, and 72,1% for AID users.

CLINICAL STUDY

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Oct 30,2023

Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study

This single-center, randomized, crossover study evaluated the safety and efficacy of fully closed-loop with ultrarapid insulin lispro in adults (n=26) with type 1 diabetes and suboptimal glycemic control compared with insulin pump therapy with continuous glucose monitoring (CGM). Participants underwent two 8-week periods of unrestricted living to compare fully closed-loop with ultrarapid insulin lispro (CamAPS HX system) with insulin pump therapy with CGM in random order. In an intention-to-treat analysis, the proportion of time glucose was in range was higher during closed-loop than during pump with CGM. In conclusin, fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adults with type 1 diabetes and suboptimal glycemic control.

CLINICAL STUDY

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Oct 19,2023

Pioneering Welsh company secures prestigious award for revolutionary diabetes device

Afon Technology has been awarded a prestigious Wales STEM Award for the creation of the world’s first non-invasive wearable blood glucose sensor. Afon Technology’s non-invasive continuous blood glucose monitoring sensor is worn on the inside of the wrist with or without a watch, and it feeds back to the user’s chosen smart device to display blood glucose data. Unlike the current continuous glucose monitoring devices, it will measure blood glucose levels in real-time without the need to penetrate the skin at all.

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Oct 13,2023

Abbott Focuses on FreeStyle Libre 3 in Germany

Abbott shared that from November 2023 onward the company will be exclusively focusing on its FreeStyle Libre 3 device in Germany, and therefore wants all the FreeStyle Libre and Libre 2 users switch to the company's newest CGM in the market. If prescribed, FreeStyle Libre 3 are covered by almost all health insurances in Germany, while out of pocket price for one sensor is €66 currently.

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