Jan 02,2024

Lilly to Participate in J.P. Morgan Healthcare Conference

Eli Lilly and Company (NYSE: LLY) will attend the 42nd Annual J.P. Morgan Healthcare Conference, Jan. 8-11, 2024. David A. Ricks, Lilly's chair and CEO, will participate in a fireside chat on Jan. 9 at 5:15 p.m. Eastern time. A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly's Investor website at https://investor.lilly.com/webcasts-and-presentations.

CONFERENCES
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Jan 02,2024

Glucotrack Announces Early Accuracy Data For Its Implantable Continuous Glucose Monitor

GlucoTrack provides updates on initial and long-term preclinical testing for the implantable Continuous Blood Glucose Monitor™ (CBGM). The Company announces the successful completion of their first preclinical study of the implantable CBGM. The study’s objective was to assess implant technique and device safety. In addition, a small sample size of sensors was used to determine device functionality. Although not intended to be an accuracy study, the sensor demonstrates a Mean Absolute Relative Difference (MARD) of 8.1% at Day 30 and 4.5% at Day 60. The study was completed with no significant adverse effects.

PRODUCT

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Jan 02,2024

Better Therapeutics Announces Submission for FDA Breakthrough Device Designation for Digital Therapeutic Platform to Treat Liver Disease

Better Therapeutics announced it has submitted a request to the FDA for Breakthrough Device Designation for its novel PDT designed to treat metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NAFLD and NASH. This regulatory step for Better Therapeutics follows the completion of the Company’s LivVita Liver Study and the subsequent publication of its results in Gastro Hep Advances. The study successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device related adverse events. The study’s authors concluded the totality of positive efficacy, safety and usability data indicates the potential of Better Therapeutics’ digitally delivered CBT to help address the significant unmet clinical needs observed in MASLD and MASH. The expected response timeline from the FDA is 60 days after receipt of a Breakthrough Device Designation application. “Securing Breakthrough Device Designation from the FDA has the potential to accelerate the expansion of our digital therapeutics platform beyond type 2 diabetes,” said Frank Karbe, President and CEO at Better Therapeutics.

PRODUCT

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Jan 03,2024

Important Update on Listing Status and Strategic Direction

After thorough analysis, Nemaura Medical’s Board of Directors and management team have made the strategic decision to accept Nasdaq’s determination to delist Nemaura Medical and move to the OTC Markets. According ot the press release from the company, the transition to the OTC Markets will provide operational flexibility, reduced compliance costs, and the ability to focus on long-term growth without the immediate pressures associated with maintaining a Nasdaq listing. Committed to creating shareholder value, they also announced that they are actively pursuing strategic partnerships critical to driving Nemaura Medical’s growth.

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Jan 03,2024

Abbott Hosts Conference Call For Fourth-Quarter Earnings

Abbott will announce its fourth-quarter 2023 financial results on Wednesday, Jan. 24, before the market opens. The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern) and will be accessible through Abbott's Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

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Dec 21,2023

Digital Diabetes Management Market Forecast Report 2023-2030

The global digital diabetes management market size is expected to reach USD 21.9 billion by 2030, expanding at a CAGR of 8.3% from 2023 to 2030, according to the research publisher. Major factors contributing to the market growth are the growing incidences of diabetes globally, the increasing number of product launches, and innovation in technologies such as predictive analytics and artificial intelligence (AI).

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Dec 21,2023

Embecta CEO sees GLP-1 opportunities as company progresses on insulin patch pump

Embecta CEO Dev Kurdikar says the company set out for its second full year since spinning off from BD with three clear goals. The company wanted to keep the core business strong, continue progressing on the separation and standing on its own and, finally, continue investing in growth — namely on its insulin patch pump development program. One of Embecta’s main goals when it first spun out of BD centered around a new, differentiated insulin patch pump technology. While many pumps address type 1 diabetes, like the Insulet Omnipod patch pump, Embecta is designing the patch pump to address the unmet needs of type 2 diabetes. The first version will be an open-loop pump that will go through the FDA 510(k) regulatory review process. Embecta also has a closed-loop version under development to follow. Kurdikar now says Embecta continues making progress, including signing an agreement with Tidepool. The company offers an FDA-cleared algorithm for type 1 diabetes and Embecta has work underway with it to adapt the algorithm for type 2. On how the GLP-1 craye may impact Embecta's business, according to Kurdikar, GLP-1s can slow disease progression and help overcome insulin resistance by making insulin work more effectively. However, while it could slow the need for insulin, Kurdikar said GLP-1s won’t eliminate it in people with type 2 diabetes. On top of that, most of Embecta’s growth comes in emerging markets where people struggle just to get insulin, let alone GLP-1s. Plus, Kurdikar even sees a route to growth in this market for Embecta.

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Dec 21,2023

Economic Costs of Diabetes in the U.S. in 2022

This study updates previous estimates of the economic burden of diagnosed diabetes, with calculation of the health resource use and indirect costs attributable to diabetes in 2022. The researchers combine the demographics of the U.S. population in 2022 with diabetes prevalence, from national survey data, epidemiological data, health care cost data, and economic data, into a Cost of Diabetes Economic Model to estimate the economic burden at the population and per capita levels. The total estimated cost of diagnosed diabetes in the U.S. in 2022 is $412.9 billion, including $306.6 billion in direct medical costs and $106.3 billion in indirect costs attributable to diabetes. For cost categories analyzed, care for people diagnosed with diabetes accounts for 1 in 4 health care dollars in the U.S., 61% of which are attributable to diabetes. On average people with diabetes incur annual medical expenditures of $19,736, of which approximately $12,022 is attributable to diabetes. People diagnosed with diabetes, on average, have medical expenditures 2.6 times higher than what would be expected without diabetes. The inflation-adjusted direct medical costs of diabetes are estimated to rise 7% from 2017 and 35% from 2012 calculations (stated in 2022 dollars).

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Dec 21,2023

Association of Continuous Glucose Monitoring Metrics With Pregnancy Outcomes in Patients With Preexisting Diabetes

Continuous glucose monitoring (CGM) improves maternal glycemic control and neonatal outcomes in type 1 diabetes pregnancies compared with self-monitoring of blood glucose. However, CGM targets for pregnancy are based on expert opinion. The study aimed to evaluate the association between CGM metrics and perinatal outcomes and identify evidence-based targets to reduce morbidity. This was a retrospective cohort study of pregnant patients with type 1 or 2 diabetes who used real-time CGM and delivered at a U.S. tertiary center (2018–2021). Multiple gestations, fetal anomalies, and early pregnancy loss were excluded. Exposures included time in range (TIR; 65–140 mg/dL), time above range (TAR), time below range (TBR), glucose variability, average glucose, and glucose management indicator. The primary outcome was a composite of fetal or neonatal mortality, large or small for gestational age at birth, neonatal intensive care unit admission, hypoglycemia, shoulder dystocia or birth trauma, and hyperbilirubinemia. Of 117 patients, 16 (13.7%) used CGM before pregnancy and 68 (58.1%) had type 1 diabetes. Overall, 98 patients (83.8%) developed the composite neonatal outcome. All CGM metrics, except TBR, were associated with neonatal morbidity. The statistically optimal TIR was 66–71%. Nearly all CGM metrics were associated with adverse neonatal morbidity and mortality and may aid management of preexisting diabetes in pregnancy. The findings support the American Diabetes Association recommendation of 70% TIR.

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Dec 21,2023

Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis– Related Diabetes

Cystic fibrosis–related diabetes (CFRD) affects up to 50% of adults with cystic fibrosis and adds significant morbidity and treatment burden. The study evaluated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas (BP) in adults with CFRD in a single-center, open-label, random-order, crossover trial. Twenty participants with CFRD were assigned in random order to 14 days each on the BP or their usual care (UC). No restrictions were placed on diet or activity. The primary outcome was the percent time sensor-measured glucose was in target range 70–180 mg/dL on days 3–14 of each arm, and key secondary outcomes included mean continuous glucose monitoring (CGM) glucose and the percent time sensor-measured glucose was in hypoglycemic range <54 mg/dL. Results showed that TIR was significantly higher in the BP arm than the UC arm. There was no significant difference in percent time with sensor-measured glucose <54 mg/dL, although self-reported symptomatic hypoglycemia episodes were higher during the BP arm than the UC arm. Adults with CFRD had improved glucose control without an increase in CGM-measured hypoglycemia with the BP compared with their UC, suggesting that this may be an important therapeutic option for this patient population.

CLINICAL STUDY

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