More FDA Approvals for Diabetes Devices and Product Advances

A round-up of recent diabetes products and updated innovations and indications considered by the Food and Drug Administration, highlighting the first integrated CGM and first implantable glucose sensor.

The growing prevalence of type 2 diabetes (T2D), and factors such as increasing obesity, and greater life expectancy are driving the diabetes device market and creating greater opportunity for devices that automatically monitor blood glucose and deliver appropriate insulin doses.1

Tresiba Prescribing Information Updated for Diabetes Management

The Food and Drug Administration (FDA) granted Novo Nordisk approval to update the Tresiba (insulin degludec injection) package insert to reflect favorable cardiovascular safety data from findings of the DEVOTE study of more than 7,600 patients with T2D and atherosclerotic CVD.2

Results of this multinational, double-blind, randomized, head-to-head clinical trial demonstrated that degludec was noninferior to insulin glargine (U-100) for major cardiovascular events, or MACE (95% confidence interval [CI]: 0.78; 1.06, P < 0.001) and also reduced the risk of severe hypoglycemia, a secondary endpoint, by 40% among the patients (95% CI: 0.48; 0.76, P < 0.001).3,4

Major Treatment Advance Promised with Dexcom G6 iCGM 

A wearable and interactive blood glucose monitoring system—the Dexcom G6— is the first to gain Food and Drug Administration marketing approval for use with compatible diabetes management products, including insulin pumps and automatic dosing systems, and blood glucose meters.5 When the Dexcom G6 reaches the market, it will be the first and only integrated continuous glucose monitoring device (iCGM), which enhances the utility of the G5 version approved in 2016 but without the capability to work with other devices.

Diabetes management will improve with the first integrated continuous glucose monitoring system.

“This is a monumental step forward as for the first time ever there is a device that completely eliminates the need for fingersticks, and is a very accurate tool that we as providers can download the patient’s glucose data and review to optimize care,” Daniel DeSalvo, MD, a pediatric endocrinologist at Texas Children’s Hospital in Houston told EndocrineWeb. “With the G6, all the features will be compatible with patients’ cell phones or a transmitter, and the sensor will have the added capability of sending predictive high and low alarms in advance so the user and members of their support system are alerted to a need for action.”

“Another game changer is the single touch applicator that even children will be able to use (with supervision),” said Dr. DeSalvo, replacing the manual insertion required by a trained individual. “With the iCGM G6, we can offer a tool to our patients that will lessen the burden of their care, but with the security of alerts so they can react to dramatic changes in a timely fashion,” he said.

Dr. DeSalvo believes this device has the potential to improve families’ lives by dramatically lessening the fear and uncertainty that comes with the risk of hypoglycemic events, Dr. DeSalvo said. “My pediatric patients will be able to go on sleepovers since the data can be shared remotely so parents will receive a warning from the  customizable alert system about an impending hypoglycemic event with time to arrange for a carb rescue.”

Similarly, coaches will be able to monitor their athletes during training and competitions, and people living alone can share their data with a friend, neighbor, and family who will be sent alerts of high or low glycemic changes. That the user will be able to customize alerts will eliminate the potential for alarm fatigue since there is an option to limit warnings except for an extreme low for which there is a breakthrough alarm.

Effective for managing both type 1 and type 2 diabetes, the Dexcom G6 is authorized for use in children who are 2 years and older and adults. The iCMG works by transmitting real-time glucose levels from a device held in place on the abdomen by a patch that must be changed every 10 days, giving patients 45% longer wear than the G5 device.

The newest Dexcom device was classified as “moderate risk,” gaining approval as a Class II medical device under a newly streamlined FDA review process.

"The FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability," said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health,5 in a FDA press release.

"The introduction of this new system promises to provide patients with lots of information, compatible with a variety of devises, assuring an ease of use that presents patients with wide flexibility to tailor their diabetes care to meet personal preferences," Dr. DeDesalvo said.

Responding to news of the DexCom G6, Amy Hess Fischl, MS, RD, CDE, program coordinator for the Teen and Adolescent Diabetes Transition Program at the University of Chicago's Kovler Diabetes Center told EndocrineWeb, “this is a big deal."

" [The G6] will not require fingerstick calibrations, the transmitter is 28% smaller to improve comfort and offer greater invisibility under clothing, the sensor not be affected by acetaminophen, and there is a simple new inserter —also a big deal for kids and adults alike,” she said, referring to the redesigned one-touch sensor applicator.

And, in the trials, the G6 was well-tolerated, said Dr. DeSalvo, “ I recommend moving the location of the sensor on the abdomen in a clockwise direction to rotate the sites while promoting healing to keep the tissue healthy and reduce the risk of infection.”

The anticipated ship date for the Dexcom G6 is June 4, according to a company spokesperson, and the cost and reimbursement are expected to remain similar to that of the G5.

First Implantable Extended Use CGM Closer to Approval  

At present, many patients with type 1 diabetes are not using a continuous glucose monitor (CGM), and up to 41% will discontinue use within a year because of problems with accuracy, cost, or most often, a negative reaction to physical use.6,7

First extended use, implantable CGM awaits FDA approval

With unanimous agreement, the Clinical Chemistry and Clinical Toxicology Devices Panel recommended that the FDA approve the Senseonics Eversense continuous glucose monitor (CGM), which is the first device designed to be implanted for up to three months; thus, delivering on an unmet need for extended use.8 In comparison, current external CGMs are limited to six to 14 days of use before a replacement sensor is needed.

Another milestone is the ability of Eversense CGM system to provide an alert ahead of a high or low glucose level.8

The Eversense device is a small (3.5 by 18.3 mm cylinder), fluorescence-based glucose sensor that would be placed subcutaneously in the upper arm and paired with a transmitter patch, which would be programmed to send glucose readings to a smartphone app. Transmitted data will include real-time information, including glucose levels, glucose trends, and alerts for hypo- and hyperglycemic levels.

First Implantable Glucose Monitoring Device for In-Home Use

Of note, the proposed indication will permit glucose monitoring in adults with type 1 or type 2 diabetes but unlike the Dexcom G5 and Abbott Libre CGM systems, the Senseonics Eversense CGM is for adjunctive use with standard home blood glucose monitoring devices as well as twice-daily fingerstick calibrations.8

The endorsement came after a review of data from three prospective trials:9,10 PRECISE, PRECISE II, or PRECISION demonstrated accuracy and safety, with 87% of readings with the falling within 15 mg/dL, or 15% of reference,8 according to the briefing document. The Eversense system was able to alert the user to 96% of hypoglycemic events and 98% of hyperglycemic events with16% and 7%, respectively, as false positives.9,10 As to side effects, where the overall infection rates are less than 1% across the three studies.

Use of the Eversense CGM would be contraindicated in patients receiving intravenously administered (but not dietary) mannitol or sorbitol because those can cause falsely elevated blood glucose readings.8 In addition, the proposed label would also include a warning about tetracyclines, which can falsely lower the readings.

Members of the committee expressed some concern regarding these noted contraindications, with an expectation that the product label and package insert would contain notifications that sensor accuracy may be affected if patients are taking any of those agents, according to the panel chair Andrew Bremer, MD, PhD, director of diabetes, endocrinology and metabolic diseases division of the National Institutes of Health in Washington, DC.

The panel also requested that the company maintain a patient registry to determine as early as possible whether or not there's a category of people for whom insertion presents more than the average risk as in older patients with thinner skin or those on glucocorticoid therapy.8

"The Eversense, the primary benefit will likely be freedom from device bulk, as opposed to performance or accuracy. While the transmitter still has to be worn on the body, it can easily be put on or taken off at any time, unlike current solutions which can only be removed at the start or end of a sensor session," David T. Ahn, MD, an endocrinologist who specializes in diabetes technology, at the University of California @ Los Angeles (UCLA) HealthSystem in San Diego, said in reviewing the product for EndocrineWeb.

"Once implanted, the sensor isn't visible or detectable and doesn't require weekly skin trauma, which can be especially appealing for pump users who are changing their insulin infusion sites every 2-3 days. Unfortunately, the likely need for mandatory fingerstick calibration is a step back in terms of convenience, but will likely be eliminated in future iterations.," Dr. Ahn said.

According to Dr. Ahn, the Senseonics Eversense offers several distinct advantages over other wearable sensors:

  • Externally worn transmitter can easily be taken on and taken off at any time;
  • Implantable sensor saves "skin real estate” and reduces “device bulk”, both of which are especially invaluable for users who use both insulin pumps and CGM
  • Insertion process occurs much less frequently (every few months rather than every week) which might help improve long-term adherence.

"That being said, the potential need for fingerstick calibrations and likely three-month wear is likely to be met with limited enthusiasm given the advent of factory-calibrated options like the Freestyle Libre and Dexcom G6," he said, "However, I do think the benefits to patients from implantable CGM will grow as the technology evolves." 

MiniMed Artificial Pancreas Efficacious in Children with T1D

In-home use of the Medtronic MiniMed Hybrid Closed-Loop Insulin Delivery Device

Children (7 to 13 years old) with type 1 diabetes (T1D) improved both glycemic outcomes and the duration in which patients remained in target range for hemoglobin A1c.11 Overall, there were no severe hypoglycemic or ketoacidotic events during the three months of use, according to Michael A. Wood, associate professor at the CS Mott Children’s Hospital at the University of Michigan in Ann Arbor, who presented the study results at ENDO 2018 in Chicago, Illinois.

Researchers compared results from 105 children ages 7 to 13 with the first pivotal trial of the system including 30 adolescents ages 14 to 21 and 94 adults ages 22 and 75 and found that the device resulted in significant reductions in A1C levels and improvements in the percentage of time spent in the 71-to-180-mg/dL range among all age groups.11

FDA approves Sanofi's High Capacity Long-Acting Insulin Pen

Sanofi receives FDA approval for highest insulin  concentration available in an injectable pen.

Sanofi received FDA approval for the Toujeo Max SoloStar, an injectable pen that will hold a concentration of 900 units/mL of insulin glargine, thereby becoming the highest capacity, long-acting injectable.12  Indicated to improve glycemic control in adult patients with diabetes, this pen will hold double the quantity of insulin as the currently available SoloStar, and the Max SoloStar will be able to deliver up to 160 units per injection.

When compared to standard insulin @ 100 units/mL, the aim is to reduce the number of injections needed to deliver the required dose of insulin, requiring fewer pens,  according to the company, potentially achieving a net savings for patients.

While the Toujeo SoloStar prefilled pens are sold in a 3-pack, the larger capacity pens are expected to reach the market in the third quarter of this year and to be sold s in 2-count packs.

Opportunity for Weight Management Skill Building…Don’t Miss This!

Despite the need to prioritize obesity treatment as a top healthcare need, most clinicians indicate insufficient time or knowledge as to the appropriate course of management to recommend to patients.15  Take advantage of a free resource, a three-part webcast, How to Speak to Patients about Obesity, which offers step-by-step strategies to get this conversation started.  

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Diabetes Prevention Possible If All Available Clinical Tools Employed
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