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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Feb 14,2023

Embecta Corp. Reports First Quarter Fiscal 2023 Financial Results

Embecta today reported financial results for the three month period ended December 31, 2022. Q1 revenues were reported as $275.7 million, down 4.7% on a reported basis; up 0.7% on a constant currency basis. "During fiscal year 2023, we remain focused on three key strategic priorities: strengthening our base business, separating and standing up embecta as an independent company, and investing in growth. Throughout the first quarter, we made progress on each of these objectives, as we continue setting up embecta for sustainable success. Given our performance during the first quarter, we are raising our guidance for our key financial reporting metrics." said Devdatt (Dev) Kurdikar, Chief Executive Officer of embecta.

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May 12,2023

embecta and Tidepool partner to develop automated insulin delivery system for people with Type 2 diabetes

Embecta and Tidepool, a nonprofit organization providing intuitive software products that help people living with diabetes, have announced that the two organizations will partner to develop an automated insulin delivery (AID) system for people living with type 2 diabetes (T2D). embecta will leverage Tidepool’s expertise in diabetes management software to develop the AID algorithm for its closed-loop patch pump system designed with the specific needs of people living with T2D, for which it received FDA Breakthrough Device Designation. "By partnering with Tidepool and tapping into their expertise on AID software development, we’re continuing our effort to deliver a user-friendly patch pump solution that will make life better for people living with T2D," said Devdatt (Dev) Kurdikar, Chief Executive Officer of embecta.

COLLABORATION PARTNERSHIP

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May 12,2023

Embecta Corp. Reports Second Quarter Fiscal 2023 Financial Results

Embecta today reported financial results for the three- and six-month periods ended March 31, 2023. Revenues in Q2 2023 were reported as $277.1 million, up 0.9% on a reported basis, and up 4.0% on a constant currency basis. Revenues in the six months ended March 31 2023 were reported as $552.8 million, down 2.0% on a reported basis and up 2.3% on a constant currency basis. In the press release, the company highlighted that they are making continued progress on the development of a type 2 closed loop insulin delivery system utilizing embecta’s proprietary patch pump, which carries Breakthrough Device Designation from the FDA, including entering into a collaboration agreement with Tidepool in which embecta will leverage Tidepool’s expertise in diabetes management software and the recently FDA 510(k) cleared insulin dosing algorithm, Tidepool Loop, in the continued development of embecta's proprietary type 2 closed-loop patch pump system.

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Aug 08,2023

Embecta increases 2023 guidance, reports closed-loop insulin delivery tech progress

Embecta shares rose this morning as it increased its full-year guidance and shared an update on its automated insulin delivery technology. Since its spinoff from BD last year, Embecta says it continues to make progress on the development of a closed-loop insulin delivery system for type 2 diabetes. The system utilizes its proprietary patch pump system, which holds FDA breakthrough device designation. Additionally, Embecta has an ongoing collaboration with Tidepool on automated insulin delivery. The companies commenced engineering work to integrate Tidepool’s insulin dosing algorithm with the patch pump to develop a closed-loop system. The diabetes technology company posted profits of $15.2 million in the quarter. That equals 26¢ per share on sales of $286.1 million for the three months ended June 30, 2023.

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Aug 22,2023

Medtronic to participate in upcoming investor conferences

Medtronic today confirmed its participation in the following upcoming investor conferences: 2023 Wells Fargo Healthcare Conference, Wednesday, September 6, 2023, at 12:00 p.m. EDT (11:00 a.m. CDT); Morgan Stanley 21st Annual Global Healthcare Conference, Monday, September 11, 2023, at 9:20 a.m. EDT (8:20 a.m. CDT) and Bank of America Global Healthcare Conference 2023, Wednesday, September 13, 2023, at 3:55 p.m. BST (9:55a.m. CDT).

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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.

CLINICAL STUDY

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Aug 24,2023

Insulet to Present at Upcoming Investor Conferences

Insulet Corporation today announced that management will present at three upcoming investor conferences (all Eastern Time): The 2023 Wells Fargo Healthcare Conference on Thursday, September 7, 2023 at 9:30 a.m.; The Baird 2023 Global Healthcare Conference on Tuesday, September 12, 2023 at 2:35 p.m.; and The Morgan Stanley 21st Annual Global Healthcare Conference on Wednesday, September 13, 2023 at 1:35 p.m.

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