Sep 13,2023

Nemaura Medical Announces Interim Results from its Collaboration with the UK’s National Health Service on its Metabolic Health & Weight Loss Program

Nemaura Medical, a medical technology company focused on developing and commercialising non-invasive wearable diagnostic devices and supporting personalized lifestyle coaching programs, today announced interim results from its metabolic health program. The primary objective of the study was to establish whether a metabolic program with a daily wear CGM worn twice a month resulted in greater engagement levels and sustainable weight reduction, and how this compared to other programs. The multi-centered study was run in collaboration with the UK’s National Health Service. Known as Miboko (Mind, Body, Konnect), the program is the first to integrate a daily-wear and non-invasive glucose sensor with the Company’s bespoke app, educational content and AI driven analytics platform. Qualitative feedback from users demonstrated substantially increased levels of understanding and empowerment on their weight loss goals, correlating to long-term behavioural changes that are pivotal to sustained weight loss. After 20 weeks of use, the program had a retention rate of 32.5%. When active participants were asked whether they would continue with the program, 64% of respondents stated they were likely or very likely to continue to use the program. The Company plans to publish more detailed results in due course.

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Aug 28,2023 TOP STORY

Insulet Announces Full Market Release of Omnipod 5 Automated Insulin Delivery System in Germany

Insulet Corporation today announced the commercial launch of its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D) in its third market, Germany. The company launched Omnipod 5 in the U.S. in August 2022, then began its launch in the UK in June of this year. Omnipod 5 is the first CE marked tubeless automated insulin delivery (also known as hybrid closed loop) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. The system includes the tubeless Pod enhanced with SmartAdjust technology and a handheld Controller integrated with the SmartBolus Calculator. The system is interoperable with Dexcom G6 for automated insulin delivery to help protect against high and low glucose levels.

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Aug 01,2023

Implementation of flash glucose monitoring in four pediatric diabetes clinics: controlled before and after study to produce real-world evidence of patient benefit

The aim of this study is to assess the real-world evidence for flash glucose monitoring (Abbott FreeStyle Libre) for children with type 1 diabetes in terms of glucose control, secondary healthcare resources and costs. The researchers conducted a controlled before and after study (approximately 12?months before and after) using routinely collected health record data on children who start using flash monitors and a control population of children with self-monitoring of blood glucose (SMBG). Outcome measures included: glycated hemoglobin (HbA1c), frequency of BG tests; frequency of sensor scans; time in recommended glucose range; short-term complications (hypoglycemia, diabetic ketoacidosis and related illness resulting in investigation) and secondary care costs. In terms of the results, there was some indication that flash monitoring might help young people improve the control of their diabetes but for the sutdy sample, the difference between finger-prick testing and flash monitoring was not clinically significant (HbA1c improvement <5 mmol/mol). Given the pace of technological change within diabetes, they suggest that research offerts should now facilitate the real-time analysis of long-term routine data on flash and continuous glucose monitors.

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Aug 22,2023

Medtronic pleased with Diabetes progress as new CGM’s FDA review ‘is progressing’

After ending fiscal 2023 on a high, the Diabetes unit at Medtronic continues to roll on into the company’s new fiscal year. Medtronic kicked off the first quarter of 2024 with its Diabetes unit helping to drive the company’s overall growth. Highlights included the U.S. launches for the MiniMed 780G automated insulin delivery system, which led to led to 6.8% revenue growth year-over-year for Medtronic Diabetes. “The turnaround in Diabetes is real and underway, and I am pleased with the progress the team is making,” CEO Geoff Martha said. Meanwhile, Medtronic saw its prescriber base rapidly expand, with a 30% increase since late June. The company says it now stands at over 13,000 since the launch. More than half the company’s previous-generation 770G installed base upgraded or placed an order for 780G since the launch. Martha has previously mentioned Medtronic’s next-generation Simplera CGM. Half the size of the Guardian 4, the disposable Simplera could theoretically be Medtronic’s counter to the existing CGMs on the market made by the likes of Abbott and Dexcom. The company is waiting for the FDA and CE mark approvals for its new CGM. Despite the advancements on the CGM front, Martha said, from an economic standpoint, Medtronic makes its money in the automated insulin delivery business with the consumables.

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Jul 17,2023

Association Between Diabetes Technology Use and Glycemic Outcomes in Adults With Type 1 Diabetes Over a Decade

The objective of this study was to assess how the use of diabetes technology in adults with type 1 diabetes impacted the average clinic-measured HbA1c levels from 2014 to 2021. The study was conducted at a single center and involved analyzing the use of diabetes technology, specifically continuous glucose monitors (CGMs) and automated insulin delivery (AID) systems, in adults with type 1 diabetes. The results showed that over the 8-year period, there were 15,903 clinic visits involving 4,174 unique patients. There was a significant increase in the use of both CGMs and AID systems, leading to an overall rise in diabetes technology utilization from 26.9% in 2014 to 82.7% in 2021. This increase in technology use was associated with a decrease in the average clinic-measured HbA1c levels, from 7.7% to 7.5%, and an increase in the percentage of adults achieving an HbA1c level below 7.0%, from 32.3% to 41.7%. Furthermore, the difference in HbA1c levels between individuals who used diabetes technology and those who did not became more pronounced over time, increasing from 0.36% in 2014 to 0.93% in 2021. In conclusion, the adoption of diabetes technology, including CGMs and AID systems, among adults with type 1 diabetes was linked to reduced HbA1c levels and an increased number of individuals achieving HbA1c levels below 7.0%.

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Jul 21,2023

Assessment of Meal Anticipation for Improving Fully Automated Insulin Delivery in Adults With Type 1 Diabetes

This research aimed to investigate the impact of meal anticipation within a fully automated insulin delivery (AID) system on glycemic control in adults with type 1 diabetes (T1D). The study used a randomized crossover clinical trial with three AID system modalities: hybrid closed loop (HCL), full closed loop (FCL), and full closed loop with meal anticipation (FCL+). Participants consumed meals at fixed times during supervised 24-hour admissions, and were started on a Tandem t:AP insulin pump set with their home insulin parameters and a Dexcom G6 CGM sensor session within 24–48 h before study start. Overall, the 24-hour glycemic control percentages for HCL, FCL, and FCL+ were 86%, 77%, and 77%, respectively. The study concluded that the inclusion of meal anticipation did not significantly enhance postprandial control within the AID systems, but it also did not increase the risk of low blood sugar when meals were delayed.

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Aug 23,2023

Welldoc Receives 11th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar

Welldoc today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar . This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation. Welldoc’s latest 510(k) enables BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes.

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Aug 04,2023

A Complete Guide to Healthy Lifestyle Interventions with Nutrisense

The Nutrisense article discusses healthy lifestyle interventions and how their solution can support them. It covers various aspects such as nutrition, exercise, social support, and sleep hygiene. Nutrisense provides personalized dietary guidance through nutrition coaching, helps monitor glucose response to exercise, offers a supportive community, and tracks sleep patterns. The article emphasizes setting achievable goals, monitoring blood sugar levels with a continuous glucose monitor (CGM), maintaining motivation, and engaging with Nutrisense's support for overall well-being.

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Aug 17,2023

Nemaura Medical Announces SFDA Approval of sugarBEAT®

Nemaura Medical, a medical technology company focused on developing and commercializing a daily disposable, wearable glucose sensor and supporting personalized lifestyle coaching programs, today announced SFDA (Saudi Food and Drug Authority) approval of sugarBEAT®, its non-invasive wearable glucose sensor. The news comes following over a year of liaisons with the SFDA through TPMENA, the Company’s licensee in the Middle East. The Company previously announced the receipt of a provisional purchase order for 1.7 million sensors and 17,000 devices from TPMENA. They will now work with its licensee to commence fulfilling this purchase order.

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Aug 03,2023

Harnessing wearables and mobile phones to improve glycemic outcomes with automated insulin delivery

Dana M Lewis, affiliated with the The Open Artificial Pancreas System project, has provided her commentary on the automated insulin delivery systems, in the Lancet Digital Health. She mentions that a challenge with any type of insulin delivery system is that once insulin is delivered, it cannot be removed from the body, and so improved ability to adjust and reduce insulin concentration in advance of or in response to physical activity is one area of opportunity for improving outcomes. The study by Peter Jacobs and colleagues suggests that it is possible to integrate activity data (ie, heart rate and accelerometer) from smart-watches into AID systems.

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