Gdask, Poland 24 June 2024 PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care, in a long-term clinical study into the safety and efficacy of lead asset PTG-007. The study monitored pediatric patients who received the autologous treatment over a period of 7 to 12 years.

The main findings were:

This long-term study is a confirmation that the significant efficacy we found in our Phase 1/2 clinical trial for PTG-007 is sustainable over the long term. At PolTREG, we believe that PTG-007 has the potential to prevent type-1 diabetes, freeing patients of the life-long burden of having to take frequent insulin injections, and the serious long-term complications of the disease. The results of this study are an important step in that direction, said Prof Piotr Trzonkowski, Chief Executive Officer of PolTREG.

With the study, PolTREG has fulfilled a requirement by the European Medicines Agency to confirm the safety of Treg therapies at least 5 years after their administration. To the best of PolTREGs knowledge, no other company currently can show similar long-term safety results of Treg therapy in T1D. This is a significant competitive advantage, and paves the way for the company to launch a pivotal Phase 2/3 study of PTG-007 to treat T1D.

PolTREG is currently seeking partnership funding for this pivotal trial, the final step required before seeking regulatory authorization for commercialisation. The company will submit the data for a peer-reviewed scientific publication in the near future. Later this year, we will also be launching a Phase 2 study in presymptomatic patients, children who are not yet showing any symptoms but in whom we are now able to detect diabetes, Prof Trzonkowski said.

PolTREG holds one of the largest and most advanced pipelines for Treg therapies for autoimmune disease, developing both polyclonal and engineered therapies. Its lead candidate, PTG-007, an autologous polyclonal Treg treatment, is in mid-stage clinical studies for T1D and multiple sclerosis (MS). Next year, PolTREG expects to start a first-in-human trial of its engineered CAR-Tregs for treatment of two neurodegenerative diseases, MS and amyotrophic lateral sclerosis (ALS). The company also is in preclinical development with two further types of engineered Treg cells.

PolTREG manufactures all its Treg therapeutics at its own GMP-certified manufacturing facility. It is the first company in the world to administer Treg therapies to patients, and, under a hospital exemption valid in Poland, the first to start receiving revenues from a Treg therapeutic for autoimmune disease. Its GMP manufacturing facility is one of Europes largest and most advanced, boasting over 2,100 sqm of laboratory space, including 15 production lines. PolTREG has the option to substantially expand the facility to accommodate manufacturing of next-generation engineered therapies and cell therapies. It can ship its wide range of cellular therapy products across Europe within 24 hours.

About PolTREG PolTREG is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership. The company will launch Phase 2 trials for PTG-007 to treat Multiple Sclerosis (MS) in the second half of 2024, for RRMS and PPMS. PolTREG also has engineered Tregs, including CAR-Tregs, antigen-specific Tregs and TCR-Tregs, in the preclinical stage. PolTREG has completed four clinical trials with more than 100 patients treated with Tregs.

For more information please visit http://www.poltreg.com.

PolTREG S.A. Prof Piotr Trzonkowski Chief Executive Officer ir@poltreg.com +48 512 532 401

Media Relations Douwe Miedema Cohesion Bureau +352 621 562 764 douwe.miedema@cohesionbureau.com

Important information The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

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PolTREG's type-1 diabetes Treg cell therapy PTG-007 - GlobeNewswire

Tzield (teplizumab) was approved in2022, becoming the first treatment to delay the onset of type 1 diabetes. Currently, Tzield is for people aged 8 and up who have stage 2type 1 diabetes meaning they have two or more autoantibodies and abnormal blood sugar, but not high enough to be stage 3 which means the person already has type 1 diabetes.

What if Tzield could be used later on, once someone has been diagnosed with diabetes, to prevent progression of the disease?

Since Tzields approval, researchers like Dr. Kevan Herold, professor of immunobiology and of medicine and an endocrinologist at Yale University, have begun testing the medication for different stages of type 1 diabetes. Indeed, previousresearch by Herold and colleagues has suggested that Tzield might preserve beta cells.

If Tzield is able to prevent progression in those with newly diagnosed diabetes, it could potentially be a big improvement. For instance, this could lead to lower insulin or no insulin , meaning fewer or no injections and a lower risk ofhypoglycemia (low blood sugar). Its possible this could even translate to longer-term benefits, such as a lower risk ofdiabetes complications.

Tzield works by attaching to and modifying T-cells, a type of immune cells that destroy the insulin-producing beta cells in type 1 diabetes. In doing so, Tzield helps interrupt the immune systems attack on beta cells and delayed the onset of type 1 diabetes in a clinical trial by two to three years.

ThePROTECT study investigated whether treatment with Tzield could prevent disease progression in people newly diagnosed with type 1 diabetes. The study included 328 children and teens, ages 8 to 17 years old, who had been diagnosed with diabetes for up to 6 weeks. Participants were randomly assigned to receive two courses of Tzield treatment or a placebo.

In the original PROTECT trial, researchers found that Tzield led to significantly greater preservation of beta cells compared to placebo.

The problem, Herold said, was that the PROTECT study was done during theCovid-19 pandemic, which threw a wrench into the conduct of the trial. As a result of the pandemic, some participants were unable to receive a full course of Tzield.

Thecurrent analysis specifically looked at participants who strictly followed the treatment protocol, meaning that they received 80% or more of the prescribed dose of Tzield. Participants who received less than 80% of the recommended dose, took prohibited medications (such as steroids or vaccines), or became pregnant were not included in this analysis.

To measure how well Tzield preserved beta cells, the researchers looked at a metric called C-peptide. C-peptide is made by beta cells during insulin production and is found in blood or urine tests. C-peptide is commonly used in studies of type 1 diabetes, such as in research investigating the cell therapy Lantidra and Vertexs VX-880 stem cell treatment. A higher C-peptide level indicates that more beta cells are working and producing insulin.

This analysis included 275 participants: 180 were randomly assigned to receive Tzield, and 95 were randomly assigned to the placebo. At the start of the study, participants had an average age of 12, BMI of 19, and an A1C of 9%.

At week 78:

Despite these findings, A1C levels were comparable between the Tzield and placebo groups.

An additional analysis found that timing of the second course of Tzield whether participants received it at 6 months as recommended, or at 12 months did not affect preservation of beta cells, Herold noted. This is an encouraging finding, as it suggests participants whose dosing was interrupted by the pandemic were still able to reap the benefits of Tzield.

This analysis of the PROTECT study showed that participants who received Tzield as directed had significantly greater beta cell preservation and time in range. Participants treated with Tzield also had lower insulin needs, which may have contributed to the lower risk of severe hypoglycemia.

These findings suggest that Tzield may be useful in preventing progression of type 1 diabetes in those newly diagnosed with the condition. Note that this study only investigated children and teens, so more research is needed, including whether Tzield is beneficial for the growing population of adults newly diagnosed with type 1 diabetes.

Overall, this analysis suggests that Tzield may be beneficial across a wider time frame not just in stage 2 type 1 diabetes. Hopefully, future research will determine the best time for participants to receive Tzield.

I think the general impression at this point is that theres probably a window of treatment opportunity that is sometime around the rapid decline in beta cell function that occurs in the peri-diagnosis period, Herold said.

Learn more about new treatments for type 1 diabetes:

Read the original here:
Could Tzield Help Children Newly Diagnosed with Diabetes? - diaTribe Foundation

The FreeStyle Libre 3 continuous glucose monitor. [Image courtesy of Abbott] The Diabetes business unit at Abbott (NYSE:ABT) has gotten off to a hot start in 2024, with some significant developments on the CGM front.

With the recent FDA clearance of two over-the-counter sensors following significant automated insulin pump integrations, 2024 has been full of good news for the company.

Speaking toDrug Delivery Business News at the American Diabetes Association Scientific Sessions in Orlando, Florida, Abbott Diabetes SVP of Commercial Operations, Chris Scoggins, said the company wants to keep that momentum going.

2024 is shaping up to be an exciting year, a good year, Scoggins said. The excitement for us, at least in the U.S., is that were just pushing deeper and deeper into this really big, underserved patient population of people with type 2 diabetes.

As Abbott broadens its patient population, Scoggins said the company is reaching new channels, like primary care, benefitting more people with diabetes, namely type 2. He called it a new chapter in the brand.

Scoggins said the push for the type 2 population is an energizing endeavor.

Something thats important for everbody to understand is, we have much work to do as an industry to really bring to the type 2 population the technologies and brands that are pretty well covered and supplied into that smaller type 1 population, Scoggins explained. Its something that puts a lot of wind in our sails.

Abbott hears patient stories often, he said, highlighting how they benefit from using the FreeStyle Libre CGM platform. According to Scoggins, it helps them see things for the first time that perhaps they failed to understand before.

Using minute-by-minute glucose readings and seeing how lifestyle choices, food choices or activity impacts glucose variability provides things that were previously hidden in a 90-day HbA1c test.

You cant really see that type of variability, Scoggins said. But, when youre doing daily time in range, all of a sudden, those lifestyle choices become very real. Those are the kinds of learnings and insights that the type 2 population can really derive benefit from when using Libre.

At the start of the year, Abbott made great strides in automated insulin delivery, pairing its FreeStyle Libre 2 Plus with Insulets Omnipod 5 in Europe and announcing compatibility with the Tandem Diabetes Care t:slim X2 system in January.

Its a really important segment, Scoggins said. Theres a high medical need for people that have type 1 diabetes and use a pump.

Globally, he explained, more than half a billion people have diabetes. The vast majority fall into the type 2 category, Scoggins said. With FreeStyle Libre, he says Abbott wanted to think about the largest groups of people underserved by diabetes technology. With the push for addressing the type 2 population taking the front seat, the company has now turned some focus toward the type 1 subgroup targeted by automated insulin delivery technology makers.

Now, Scoggins says, its important that Abbott gets it right with regard to automated insulin delivery.

Right now, the company offers the FreeStyle Libre 2 plus, built on the Libre 2 platform, in the U.S. with Tandem. However, it actually started pump connectivity with Libre 3, the latest generation, in Europe, with Ypsomed and CamDiab.

Scoggins said the company feels strongly about the process of working with a pump partner to create an effectively connected, quality, regulated system that everyone feels good about, both for regulatory and technological reasons. Ultimately, the company intends to continue expanding the options for this patient base.

Were going to help the patients we serve and engender the confidence of the endocrinologist, so you know to trust Libre to connect to a pump, Scoggins explained. While we are showing up in the pump space later than some of our competitors, our intent is to not just show up, but to become the brand of choice and the standard of care.

We dont want to just show up and participate. We want to be the reference.

The launch of Lingo effectively a CGM for monitoring health and wellness outside diabetes widens the population Abbott can reach, but, in a diabetes-specific sense, the over-the-counter Libre Rio is yet another major step forward in reaching more patients.

Libre Rio provides monitoring for adults with type 2 diabetes who arent on insulin and manage diabetes through lifestyle modifications. Like the companies prescription CGMs, Libre Riowill rival Dexcoms OTC Stelo for people with type 2 diabetes who do not use insulin.

Theres not a one-product-serves-all solution that we could see meet the needs in the market, Scoggins said. Thats why we offered to separate sensors to serve both of these consumers.

As a research-driven organization, Scoggins says Abbott is always looking to build upon its platforms, like with Rio and Lingo.DVP, Technical Operations, Marc Taub, explained this innovation process last fall at DeviceTalks West.The company also continues development on afirst-of-its kind, all-in-one sensor that measures both glucose and ketone.

Scoggins said the company has been somewhat surprised by the reaction of the medical community and the interest in understanding how that sensor could help people at risk for diabetic ketoacidosis (DKA).

Abbott built this sensor on the Libre 3 form factor. Scoggins said it fits with what FreeStyle Libre stands for, providing functional understanding of the variability of glucose but also visibility into the risk of ketosis. It also improves upon the existing ketone strip which Abbott offers with low utilization of that product. The convenience of having that second measure included in a glucose sensor could set the device apart.

Still in development and not at the stage of commercial discussions yet, the sensor still could garner plenty of attention. Scoggins expects rigorous clinical activity to prepare for regulatory submission and more to come on this front.

More can benefit and that interest in the multi-analyte sensor, I think its just kind of scratching the surface, Scoggins said. Theres so much more we can do.

More here:
Abbott targets type 2 diabetes with 'exciting year' ahead - Drug Delivery Business News

Francisco Pasquel, MD, MPH Credit: Emory University

Use of the Omnipod 5 automated insulin delivery (AID) system decreased median HbA1c from 8.2% to 7.4% in 13 weeks among users with type 2 diabetes, according to results of the SECURE-T2D trial.

Billed as the largest, longest, and most racially diverse study of AID in people with type 2 diabetes to date, results of the SECURE-T2D trial demonstrate provided substantial benefit, including a nearly 5-hour increase in time in range per day, with results of AID use similar across subgroups defined by race/ethnicity, GLP-1 RA use, prior insulin regimen, and pre-study insulin meal dosing method.1,2

Our findings demonstrate substantial improvements in blood glucose outcomes and overall quality of life, highlighting the potential for this innovative technology to transform type 2 diabetes management with automated insulin delivery, said chair of the study Francisco Pasquel, MD, MPH, associate professor of Medicine of Emory University.2 As the largest study of AID therapy in people with type 2 diabetes, we look forward to these results supporting the FDA clearance of Omnipod 5 as a safe and effective therapy for this patient population.

With the receipt of FDA clearance for type 1 diabetes in January 2022, the Omnipod 5 became the first tubeless AID system with smartphone control. As the benefits of diabetes technology has continued to emerge in recent years, an interest in their utility among people with type 2 diabetes has become evident. At the 2024 International Conference on Advanced Technologies & Treatments for Diabetes, Insulet presented data from an 8-week feasibility study among adults with type 2 diabetes confirming the potential of the Omnipod 5 among this patient population.3,4

In SECURE-T2D, which was presented at the 84th American Diabetes Association Scientific Sessions, investigators enrolled 305 individuals from 21 sites across the US. For inclusion, patients were required to be 18 to 75 years of age, have type 2 diabetes, have been on their current insulin regimen for 3 or more months, and have no previous AID use. Investigators pointed out HbA1c requirements required patients to have an HbA1c less than 12% among basal/bolus or pre-mix insulin users and 7% or more and less than 12% among basal-only users.1

The study cohort had a mean age of 57 (SD, 11) years and 57% were female. The median duration of diabetes was 17 years, the mean HbA1c at screening was 8.2% (SD, 1.4), 62% were currently using CGM, and 25% had never used CGM. Regarding race and ethnicity, 50% of patients were non-Hispanic White, 24% were non-Hispanic Black, 22% were Hispanic or Latino, and 2% were Asian or Pacific Islander.1

Per trial design, participants underwent a 14-day period of standard therapy to collect baseline data, which was followed by a 13-week period where all patients received the Omnipod 5 AID system with the Dexcom G6 continuous glucose monitoring system.1

At the end of the 13 weeks, the mean HbA1c among the cohort decreased from 8.2% (SD, 1.3) at baseline to 7.4% (SD, 0.9) (treatment effect= -0.8%; 95% CI, -1.0 to -0.7; P <.001). When assessing secondary glycemic metrics, results indicated use was associated with a 20% increase in time in range of 70 to 180 mg/dL (4.8 hours per day) and a 20% decrease in time above 180 mg/dL (4.8 hours per day) (P <.001). Investigators pointed out these improvements in time in range were primarily driven by a significant reduction in hyperglycemia with no increase in hypoglycemia.1

When assessing secondary endpoints in a pre-specified hierarchical order, significance was achieved for the first 11 endpoints, including mean glucose, time in range of 70 to 180 mg/dL, time in range of 70 to 140 mg/dL, time at or above 300 mg/dL, time above 250 mg/dL, time above 180 mg/dL, time below 70 mg/dL, time below 54 mg/dL, diabetes distress, percentage with high distress scores, and sleep quality. After the 13-week period with Omnipod 5, 90% of participants indicated they would recommend Omnipod 5 to a friend and 78% of participants expressed interest in continuing use of Omnipod 5 following study conclusion.1

These data demonstrate that simple, easy-to-use AID technology, such as Omnipod 5, can be adopted by a broad population of people with type 2 diabetes and improve their lives, said Trang Ly, MBBS, PhD, senior vice president and medical director at Insulet Corporation.2 A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race. These results could have a particularly striking impact among Black and Hispanic people, who experience a higher prevalence of type 2 diabetes and increased mortality rates.

References:

Read more:
Omnipod 5 AID System Proves Benefit for Adults with Type 2 Diabetes - MD Magazine

South Africas public health care system has run out of the human insulin pens that it provides to people with diabetes, as the pharmaceutical industry shifts production priorities to blockbuster weight-loss drugs that use a similar device for delivery.

Novo Nordisk, the company that has supplied South Africa with human insulin in pens for a decade, opted not to renew its contract, which expired last month. No other company has bid on the contract to supply 14 million pens for the next three years, at about $2 per pen.

Current manufacturing capacity limitations mean that patients in some countries, including South Africa, may have limited access to our human insulins in pens, said Ambre James-Brown, a spokeswoman for Novo Nordisk. The company did not reply to questions about which other countries are affected.

Novo Nordisks drugs Ozempic and Wegovy, which are widely prescribed in the U.S. for weight loss, are sold in single-use pens produced by many of the same contracted manufacturers who make the multidose insulin pens. A months supply of Ozempic in the United States costs about $1,000, far more than insulin.

Novo Nordisk dominates the global market for insulin in pens and has supplied South Africa since 2014. Eli Lilly, the other major producer, has indicated in recent months that it is struggling to keep up with the significant demand for its weight-loss drug Zepbound.

This is because of the global demand for Ozempic and these drugs, said Khadija Jamaloodien, the director of sector-wide procurement for South Africas health service. Theyre shifting the focus on the more profitable line.

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South Africa Runs Out of Insulin Pens as Global Supply Shifts to Weight-Loss Drugs - The New York Times

ORLANDO, Fla., June 22, 2024 /PRNewswire/ -- Today, the American Diabetes Association (ADA) announced the winners of its Innovation Challenge competition. Innovators showcased novel ideas for diabetes care before a panel of potentialfunders and an audience of professionals in the field, with the goal of furthering transformative solutions for people living with diabetes, their families, and caregivers. Five finalists pitched ideas from the main stage at the ADA's 84th Scientific Sessions and three winners were chosen Diatech Diabetes, Spotlight Communications, and Symbio Cell Tech.

The competition comes amidst a diabetes epidemic affecting over 38 million Americans. Increased efforts to bend the curve of diabetes, coupled with advancements in technology and scientific understanding have created a growing market for diabetes startups.

"The potentially game-changing ideas presented by these innovators bring the ADA's vision of a life free of diabetes and all its burdens closer to reality. We're proud to support emerging advancements in diabetes research and care," said Robert Gabbay, chief scientific and medical officer of the ADA. "Our congratulations to the winners, with appreciation for their hard work and excitement for what's to come."

This year's winners and finalists included:

Winner: Diatech Diabetes A software platform to improve infusion failure detection in insulin pump and automated insulin deliver (AID) systems. The mobile app integrates with insulin pumps allowing people with diabetes to monitor their infusions and avoid hyperglycemia.

Winner: Spotlight Communications A clinical tool to address patient-identified priority concerns and immediately map resources to meet unmet physical, mental and social wellbeing needs.

Winner: Symbio Cell Tech A biotherapy for patients with type 1 diabetes that does not require encapsulation devices or antirejection drugs.

Finalist: Spect A smartphone-enabled telemedicine platform for eye screening that trains medical assistants and returns a diagnostic report in minutes.

Finalist: Valendo Health Delivery of a program to address the shortage of endocrinologists, beginning with increasing clinical capacity and enhancing patient care by delivering telehealth and remote patient monitoring services.

The application period for next year's Innovation Challenge will open in January 2025.

About the American Diabetes Association's Scientific SessionsThe ADA's 84th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention, and care, will be held in Orlando, FL on June 21-24. More than 11,000 leading physicians, scientists, and health care professionals from around the world are expected to convene both in person and virtually to unveil cutting-edge research, treatment recommendations, and advances toward a cure for diabetes. Attendees will receive exclusive access to thousands of original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Join the Scientific Sessions conversation on social media using #ADAScientificSessions.

About the American Diabetes AssociationThe American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For 83 years, the ADA has driven discovery and research to treat, manage, and prevent diabetes while working relentlessly for a cure. Through advocacy, program development, and education we aim to improve the quality of life for the 136 million Americans living with diabetes or prediabetes. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Spanish Facebook (Asociacin Americana de la Diabetes), LinkedIn (American Diabetes Association), Twitter (@AmDiabetesAssn), and Instagram (@AmDiabetesAssn).

Media Contact: Amy Robinson [emailprotected]

SOURCE American Diabetes Association

Continued here:
The American Diabetes Association Names Winners of Diabetes Innovation Challenge - PR Newswire

Chapters

00:00 - Intro

00:40 - Abbott OTC CGM

06:20 - Diabetes Technology Pipeline

10:45 - JDRF Rebrands as Breakthrough T1D

15:15 -US FDA Clearance of CamAPS FX

In this episode ofDiabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives,hostsDiana Isaacs, PharmD, and Natalie Bellini, DNP, provide a June 2024 update focusing on a trio of topics across the spectrum of diabetes management. In the episode, hosts discuss the US Food and Drug Administration (FDA) clearance of 2 new over-the-counter (OTC) continuous glucose monitoring (CGM) systems from Abbott, the renaming of JDRF to Breakthrough T1D, and the FDA clearance of the CamAPS FX for people with type 1 diabetes.

After spotlighting Dexcoms Stelo in a previous episode, hosts started off this episode by discussing Abbotts announcement of US Food and Drug Administration clearance for a pair of new OTC CGM devices: the Lingo and the Libre Rio.1

Billed by Abbott as a consumer biowearable, the Lingo is designed for use by consumers 18 years and older looking to improve their overall health by offering them the ability to track glucose and provide personalized insights as well as customized coaching. The Lingo will feature a biosensor designed to be worn on the upper arm with a 14-day wear period. Data obtained by the sensor will be continuously streamed to a smartphone application for the user.1

Unlike the Lingo, the Libre Rio is billed by Abbott as the companys first OTC system for those with type 2 diabetes who do not use insulin and manage their diabetes with lifestyle modifications. The system boasts a measurement range of 40 to 400 mg/dL.1

On June 04, 2024, the JDRF announced it would be changing its name and will now be called Breakthrough T1D. Announced in a simulcast during the organizations annual Government Day Conference, the new name is a reflection of the medical communitys recognition that type 1 diabetes can develop at any age, regardless of family history.2

As an adult and scientist living with type 1 diabetes, I believe our new name, Breakthrough T1D, will help to deepen engagement and support across the entire community as we drive toward curing type 1 diabetes, said Aaron J. Kowalski, PhD, chief executive officer of Breakthrough T1D.2

To complete the episode, the hosts celebrate a long-awaited announcement for those up to date on developments in diabetes technology: the US FDA approval of CamAPS FX.3,4

A prescription-only mobile application developed by CamDiab Ltd, CamAPS FX is designed for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in people 2 years of age or older. However, much of the excitement surrounding the algorithm revolves around it being the first of its kind for use in pregnant patients who may have complications with type 1 diabetes.3,4

Compatible with other interoperable devices that meet pre-specified acceptance criteria, the application works with an integrated continuous glucose monitor to control a compatible insulin pump. At the time of clearance by the US FDA, the CamAPS FX closed-loop algorithm had already received clearance for a similar indication in Europe and been used by more than 27,000 people in 15 countries.3,4

References:

More:
Diabetes Dialogue: June 2024 Updates in Diabetes Tech and Type 1 Diabetes - MD Magazine

The Mobi miniature, durable automated insulin patch pump worn on a hikers leg. [Image courtesy of Tandem Diabetes Care] Tandem Diabetes Care (Nasdaq:TNDM) today announced real-world insights highlighting user satisfaction with its Mobi automated insulin pump.

San Diego-basedTandem launched Mobi, the worlds smallest, durable automated insulin delivery (AID) system in the U.S. this year. Itreceived FDA clearance for people with diabetes ages six and up in July 2023. The system pairs with both the Dexcom G6 and G7 CGMs, offering multiple options to patients. Tandem also plans to integrate Mobi (and its t:slim X2 pump) with the Abbott FreeStyle Libre 3 in the future.

Tandem shared a survey on user satisfaction and wearability, finding that 86% of patients reported that they were satisfied or very satisfied with Mobi regardless of prior therapy and agreed that Mobi helps improve their quality of life. The company presented its data at the American Diabetes Association Scientific Sessions in Orlando, Florida.

These real-world user insights provide evidence that we are furthering our mission to improve the lives of people with diabetes by demonstrating that Tandem Mobi not only meets, but exceeds user expectations, said Dr. Jordan Pinsker, chief medical officer at Tandem Diabetes Care. We are proud to share these results at ADA and will continue to innovate to provide the diabetes community with choice and improved quality of life.

In a six-week limited launch survey, the company heard from early users who previously used multiple daily injections (MDI), other insulin pumps (tubed and tubeless) or previous tandem pumps. They exhibited high satisfaction with the wearability features of Mobi combined with the Control-IQ algorithm.

Mobis size enables users to wear it almost anywhere with greater discretion, comfort and flexibility. Control-IQ technology, meanwhile, predicts and helps prevent highs and lows.

For prior pump users, 78% said Mobi reduces diabetes management burden and 88% say its easy to use, while 80% said it delivers more freedom in their lives.

Other data shared at ADA included Mobi users and highlighted improved time in range with no increase in time spent below range. Younger users highlighted form factor, portability, discreteness and wearability as paramount to satisfaction and ongoing use.

Tandem highlighted a number of features contributing to these satisfaction drivers, including a 30-unit minimum fill to reduce insulin waste for those with low insulin requirements. Mobis physical on-pump quick bolus button enables simple, discreet bolusing with programming in grams or unit increments.

On-body wear features a lightweight adhesive sleeve and five-inch tubing, while users can control Mobi from their personal iPhone.

See the rest here:
Tandem reports improved quality of life with Mobi AID system - Drug Delivery Business News

An analysis of the SURMOUNT 1 and 2 trials presented at the 84th American Diabetes Association Scientific Sessions offers further insight into the differences in weight loss observed among people with and without type 2 diabetes achieved with use of tirzepatide.

Results of the study, which leveraged propensity score matching and mixed models for repeated measures (MMRM) analysis to compare the effect of Eli Lilly and Companys dual GIP/GLP-1 receptor agonist in those with overweight or obesity based on diabetes status, suggest the differences in weight reductions observed persisted after matching key baseline characteristics, which investigators purport indicates other contributing factors drive these differences.

The current study was led by Rodolfo Galindo, MD, of Emory University, to better understand potential drivers of the difference in effects seen with tirzepatide on body weight reductions in people with overweight or obesity with or without type 2 diabetes. With this in mind, investigators designed their study to use propensity score matched cohorts, with matching based on age, gender, weight, BMI, antidepressant use or depression, and obesity-related comorbidities, in MMRM analysis to compare the percent of weight reduction achieved at week 72 between those with and without type 2 diabetes form within SURMOUNT-1 and SURMOUNT-2.

Investigators pointed out initial analysis of the cohorts revealed those in SURMOUNT-2 were older, had a greater proportion of more males, lower weight, greater HbA1c, and greater comorbidity burden compared to their counterparts in SURMOUNT-1.

Results of the ADA 2024 study indicate the differences in weight reduction observed at week 72 remained even after propensity score matching, with those in the SURMOUNT-1 cohort achieving greater levels of body weight reduction than their counterparts in SURMOUNT-2 with type 2 diabetes.

For more on the study, check out our interview with study investigator W. Timothy Garvey, MD, director of the Diabetes Research Center at the University of Alabama - Birmingham.

Relevant disclosures for Dr. Garvey include Boehringer-Ingelheim, Novo Nordisk, Eli Lilly and Company, Merck & Co., Inc., Alnylam Pharmaceuticals, Inc., Fractyl Health, Inc., Inogen, Epitomee, Pfizer Inc., and Neurovalens.

References:

See the original post:
Timothy Garvey, MD: Drivers of Differences in Weight Loss with Incretins Based on Diabetes Status - MD Magazine

Findings Reveal Efficacy of Novel Inhaler to Improve Glycemic Control for Patients with Type 1 Diabetes

ORLANDO, Fla., June 22, 2024 /PRNewswire/ --Today, findings from INHALE-3, a pivotal trial examining the use of inhaled insulin in adults with type 1 diabetes (T1D), were announced, highlighting the potential of an alternative insulin solution to enhance diabetes management. The results were presented as a symposium at the 84th Scientific Sessions of the American Diabetes Association (ADA) in Orlando, FL.

Type 1 diabetes affects 11.6% of the American population and millions of individuals globally, requiring ongoing insulin therapy to manage blood glucose levels. Traditional insulin delivery methods include multiple daily injections or automated insulin delivery systems. However, for some patients, there is a need for new solutions to improve convenience, ease of use, and effective glycemic management.

INHALE-3, a randomized trial, compared the efficacy of an inhaled insulin regimen (Afrezza) plus degludec insulin (Tresiba) against usual care over 17 weeks at 19 centers in the U.S. The trial included 123 adults with type 1 diabetes divided into two groups: one receiving inhaled insulin (Afrezza) plus degludec insulin, and the other continuing their usual care, which included automated insulin delivery systems in about half or multiple daily injections. The study's primary endpoint was a change in HbA1c levels, a critical marker of long-term blood glucose control. Secondary endpoints included changes in time-in-range and hypoglycemia measured with continuous glucose monitoring and patient-reported outcomes on insulin delivery satisfaction.

More participants using the inhaled insulin regimen experienced significant improvements in HbA1c levels compared to those on usual care. Notably, 21% of those on inhaled insulin had an HbA1c improvement of greater than 0.5%, while this was seen in only 5% of those with standard care. Furthermore, among participants who had an HbA1c level greater than or equal to 7% at the start of the study, 21% of those on inhaled insulin achieved the HbA1c goal of less than 7% while no participants receiving standard care achieved this HbA1c goal. Nineteen percent of participants who switched from using an automated insulin delivery system to using inhaled insulin plus degludec achieved an HbA1c improvement greater than 0.5%. In contrast to these positive findings, the study found that the insulin regimen with inhaled insulin and degludec was not for everyone: 26% of the patients in the inhaled insulin group had a worsening of HbA1c greater than 0.5% compared with 3% with standard care. Importantly, over half of the study participants wished to continue the inhaled insulin after the study completion.

"The INHALE-3 study's findings will impact diabetes management by providing healthcare providers and patients with an alternative insulin delivery method," said Irl B. Hirsch, MD, University of Washington, and lead author of the study. "These results will assist in better informing clinical decisions and tailoring treatment plans to individual patient needs, potentially improving adherence, patient satisfaction, and overall outcomes."

Building on the promising results of INHALE-3, further research will focus on the impact of inhaled insulin on a broader patient population, including pediatrics and pregnancy. These studies aim to reinforce the role of inhaled insulin in comprehensive diabetes care.

Research presentation details:

Dr. Hirsch will present the findings at the following symposium:

About the ADA's Scientific Sessions

The ADA's 84th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention, and care, will be held in Orlando, FL on June 21-24. More than 11,000 leading physicians, scientists, and health care professionals from around the world are expected to convene both in person and virtually to unveil cutting-edge research, treatment recommendations, and advances toward a cure for diabetes. Attendees will receive exclusive access to thousands of original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Join the Scientific Sessions conversation on social media using #ADAScientificSessions.

About the American Diabetes Association

The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For 83 years, the ADA has driven discovery and research to treat, manage, and prevent diabetes while working relentlessly for a cure. Through advocacy, program development, and education we aim to improve the quality of life for the over 136 million Americans living with diabetes or prediabetes. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us atdiabetes.orgor call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Spanish Facebook (Asociacin Americana de la Diabetes), LinkedIn (American Diabetes Association), Twitter (@AmDiabetesAssn), and Instagram (@AmDiabetesAssn).

Contact: Amy Robinson [emailprotected]

SOURCE American Diabetes Association

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Study Shows Promising Results for Inhaled Insulin as Treatment for Type 1 Diabetes - PR Newswire