Diabetes Drug Sales Face Severe Challenges! These 7 Cutting-Edge Technologies Could Be the Lifesaver

Not long ago, the Advanced Technologies & Treatments for Diabetes (ATTD) conference was held in Paris, gathering companies from the diabetes treatment sector to share extensive efficacy data. For instance, closed-loop systems, which enable patients with diabetes to continuously monitor their blood glucose levels and automatically adjust insulin dosage, have been proven effective for individuals with type 1 diabetes. This is an exciting time for the field. VCBeat (WeChat ID: vcbeat) has compiled the latest trends in diabetes medications and devices for you.

The United States has 29 million patients with diabetes, yet few new drugs have been developed for its treatment. Most of the therapies that have emerged in recent years are merely incremental improvements over previous ones, such as replacing daily dosing with weekly dosing or substituting injections for oral administration.

Are pharmaceutical companies also at a loss when it comes to diabetes? Not entirely.

However, whether pharmaceutical companies’ ideas can withstand the test of the market is another matter. In the early stages of research, many promising technologies have emerged. Nevertheless, although drugs on the market may show favorable results in preliminary trials, given the high development costs and stringent regulatory approval requirements, pharmaceutical companies can only bear these costs after achieving genuine breakthroughs—a feat that is difficult to accomplish.

Dr. John Buse, Director of the Diabetes Center at the University of North Carolina at Chapel Hill, stated, “There remains unmet need in the market, but there is a lack of truly effective drugs; this is not like selling [products] 10 years ago.”Acarbose"In that case, you must take this medication three times a day to stimulate gastrointestinal motility. Based solely on such dosing instructions, the drug would not even advance to Phase II of the approval process."

Oral insulin has long been considered the holy grail of diabetes research, as it would allow patients to move away from routine injections to easily administered pills; however, its cost-effectiveness has not been favorable.At the end of last year, Danish pharmaceutical manufacturerNovo Nordisk（Novo Nordisk) PushSuch a project has emerged. Not because it failed in clinical trials, but ratherDue to excessively high development costs, a reliable return on investment cannot be achieved.。

This logic frustrates patients and their advocates.

“I hope those who hold this view can spend some time with individuals facing the challenges of type 1 diabetes,” said Derek Rapp, CEO of JDRF, a leading advocate and funder of research in this field.

However, the diabetes drug market has become fiercely competitive and overcrowded.Industry leader Sanofi (Sanofi），Novo Nordisk（Novo Nordisk）Eli Lilly has issued grim sales forecasts in recent years, as pricing pressures have eroded the profits generated by its past achievements.. Due to an unexpected decline in projected revenue, the CEO of Novo Nordisk abruptly decided to resign last year.

“The challenges have escalated,” said Dr. Philip Larsen, Head of Diabetes Research at Sanofi. “Major pharmaceutical companies are now striving to gain a competitive edge through innovation.”

This means taking a gamble early in the research to eliminate injectable formulations, despite the high probability of failure.

For example, scientists at Sanofi have pointed out that gastric bypass surgery significantly improves type 2 diabetes, even leading to remission in some patients. Their question is: Can the effects of the surgery be replicated with medication? They have a drug currently in mid-stage development that aims to “mimic the mixed hormones produced after surgery,” Larsen stated, with the goal of inventing a needle-free injection method.

Pharmaceutical companies are also researching so-called "smart insulin," which is activated when blood glucose levels are too high and deactivated once they return to normal. This deactivation mechanism is harmless to patients and reduces the risk of hypoglycemia.。

Other institutions are conducting research on the gut microbiota—a network of trillions of microorganisms—in the hope of finding a therapy to improve diabetes.

“We are not innovating for the sake of innovation,” said Dr. Ruth Gimeno, Vice President of Diabetes Research at Eli Lilly. “We aim to make a genuine difference, allowing ourselves more time rather than merely increasing the value of products in our pharmaceutical pipeline.”

For some physicians, the key is not to have more new products, but to teach them how to use the existing products on the market.

GLP-1 agonists, a class of drugs introduced more than a decade ago, have been proven to lower blood glucose levels in patients and reduce the risk of long-term cardiovascular and cerebrovascular complications.

The same applies to SGLT2 inhibitors, which were introduced in 2013 and have been shown to reduce the risk of death by 32% in patients with type 2 diabetes.

However, it has not yet been widely adopted.

Part of the reason is that most primary care physicians do not know how to use them.,” said Dr. Athena Philis-Tsimikas of the Scripps Whittier Diabetes Institute in California.

Another contributing factor is the restriction imposed by medical insurance clauses, which compel physicians to follow “some absurd procedures” step by step in order to secure coverage for new medications under patients’ health plans."This is not the kind of innovation we want," said Philis-Tsimikas. "We are not leveraging what we already have."

At the same time, we should also recognize the efforts of pharmaceutical companies, which are gradually expanding their R&D scope to include new technologies, wearable devices, glucose monitors, and advanced insulin pumps. These technologies and devices can be used in conjunction with medications to improve patients’ quality of life.. As Dr. Robert Gabbay, Chief Medical Officer of the Joslin Diabetes Center at Harvard University, stated, “Devices are becoming increasingly important.”

“Researchers are exploring some exciting and promising avenues, but I believe the scope of diabetes treatment needs to expand beyond the pharmaceutical sector.” Let us now turn our attention to the latest developments in advanced technologies and devices for diabetes care.

On February 16, the nonprofit organization T1D Exchange released a key research brief on diabetes care and presented the findings at a conference. These data further corroborate the FDA’s recent withdrawal of its clearance for Dexcom’s continuous glucose monitoring (CGM) system for insulin dosing decisions.

This study conducted a six-month observation of 226 adult users of continuous glucose monitoring (CGM) systems. Among them, 149 individuals used CGM to determine insulin dosages, while the remaining 77 used fingerstick blood glucose meters, in accordance with the requirements of most current CGM systems. The trial outcomes were consistent between the two groups.

“This study represents a significant step forward in supporting the automated regulation of insulin delivery for patients with type 1 diabetes,” said Dana Ball, Executive Director and Co-Founder of T1D Exchange, in a statement. “These data support the FDA’s recent decision to approve the insulin dosing indication for the Dexcom G5, as well as the removal of restrictions that previously prevented Medicare reimbursement for continuous glucose monitoring (CGM) costs.”

Integrity Applications has launched a new non-invasive blood glucose monitor called Gluco Trak, which clips onto the earlobe. Data indicate that this device offers greater accuracy than previous generations. Furthermore, the data demonstrate enhanced measurement stability, with consistent readings obtained from both earlobes. The company has also addressed inaccuracies previously observed in preprandial and postprandial measurements.

Aspire Ventures announced that Tempo Health’s Rhythm system, deployed at the specialized treatment center Diabeter in Europe, demonstrated outstanding performance in an observational study. Rhythm is a system built on Aspire’s A2I adaptive artificial intelligence platform.

Rhythm uses A2I to predict and monitor blood glucose levels in patients with diabetes, using data from non-invasive biosensors.

Studies have demonstrated that, compared with outcomes from active monitoring by Diabeter physicians and from patient-centered remote monitoring groups for diabetic patients, Rhythm enables 7 out of 8 patients to increase their time in range by 20% in a timely manner and reduce blood glucose levels by 9%.

Glytec, a company based in Waltham, Massachusetts, has developed personalized treatment and decision support modules for patients with diabetes and presented two studies on its Glucommander system. One study showed that mean A1C levels decreased from a baseline of 10.2% to 7.7% at three months and to 7.6% at six months. The other study focused on patients with diabetes who were prescribed subcutaneous insulin and used the Glucommander system. Among 5,718 patients, the median time to reach the prescribed glucose target was 0.8 days. Once the target range was achieved, 67.9% of all blood glucose readings remained between 70 mg/dL and 180 mg/dL.

Insulet, the manufacturer of the tubeless Omnipod series of insulin pumps, provided data from its own closed-loop system, a hybrid system known as OmniPod Horizon. The study lasted 36 hours and involved 24 participants. It utilized an enhanced version of the Omnipod, a Dexcom CGM sensor, and Insulet’s proprietary model predictive control algorithm. The company stated that, compared to pre-study glucose ranges, the system significantly reduced the time spent in hypoglycemic glucose ranges. Furthermore, during the study, patients maintained their blood glucose levels within the target range for 69% of the time, including 90% of the time overnight.

Valeritas manufactures a wearable, disposable insulin delivery device called V-Go. Shared data indicate that, compared with insulin pen injectors, this device achieves greater reductions in HbA1c levels and insulin dosage.

In a retrospective study involving 107 participants, approximately half switched from pen-style insulin injectors to V-Go. The A1c levels of V-Go users decreased by 1.96%, whereas those of pen-style insulin injector users decreased by 1.23%.

Compared with users of pen-style insulin injectors, V-Go users require a lower insulin dose, with average daily dosages of 56 units and 77 units, respectively. Users of pen-style insulin injectors need an average of 3.6 injections per day, whereas V-Go users require only one application per day.

UK-based medical device company Nemaura Medical showcased its continuous glucose monitoring patch, sugarBEAT, which is still under development. At a seminar, the company demonstrated the needle-free, disposable patch, approximately 1 mm thick, which uses a small electronic sensor to measure blood glucose levels and transmits the data via Bluetooth to a companion smartphone app. The company expects to launch the product next year at a “cost-competitive” price.

The technological advancement of diabetes treatment and monitoring devices must keep pace with the spread of the disease, continuously meeting the needs of patients and healthcare professionals. This requires pharmaceutical companies to adopt a broader perspective by integrating technology, instruments, and medications to improve the lives of individuals with diabetes.

References:

【1】

https://www.statnews.com/2017/02/19/diabetes-drugs-slow/

【2】

http://www.mobihealthnews.com/content/roundup-news-advanced-technologies-treatments-diabetes-conference