Dexcom G7 CGM System Receives FDA Clearance posted on EndocrinologyNetwork.com, 8 December 2022.
Dexcom has announced their Dexcom G7 Continuous Glucose Monitoring (CGM) system has received clearance from the US Food and Drug Administration for people with all types of diabetes aged 2 years and older.
Announced on December 8, the Dexcom G7 boasts an overall MARD of 8.2% and is billed by the company as the most accurate CGM cleared by the FDA and the most covered CGM on the market.
The Dexcom G7 carries over several key features from the previous generation system, including the lack of need for fingersticks, scanning, or calibration, the ability to send real-time glucose readings automatically every 5 minutes to a compatible device, and the ability to share glucose data with up to 10 followers. Within their aforementioned release, Dexcom lists notable differences between the Dexcom G7 CGM system and the previous generation G6 system. Some of these key differences are highlighted below:
- 60% smaller, all-in-one discreet wearable, with fewer components
- 30-minute sensor warmup
- 12-hour grace period to replace finished sensors
- Redesigned mobile app
- Indicated for wear on the back of the upper arm for ages 2 years and older or the upper buttocks for ages 2-17
Further in their announcement, Dexcom noted they expect a US launch of the Dexcom G7 CGM system in early 2023. Additionally, in order to facilitate immediate access, the company will offer accessible cash pay options as the company transitions coverage availability.
Read more: Dexcom G7 CGM System Receives FDA Clearance
Battle Royale: Freestyle Libre 3 & Dexcom G7 Face Off, by Tim Street for Diabettech.com, 12 December 2022.
Tim Street has been wearing the Libre 3, Dexcom G6, and G7, to compare performance across all three. And here are the results, laid out showing the Consensus Error Grid for each device. If you don’t want to read the details, then the basics are that Libre3 proved to be the best performer of the three, with the best results on nearly all of the metrics in this n=1 experiment.
Here’s the outline of his approach: Comparing six CGMs… How?
And the results, based on Tim’s N=1:
- The Libre 3 was more consistent and had considerably fewer data points that fell outside the 20/20 rule.
- While the percentage of hypos not detected looks high for the G6 and G7 (at 27.3%), Libre 3 was better than the outcome from the G6 in the “Six of the best” experiment.
- The final table that we have shows the number of times that the different systems incorrectly called “Hypo” when blood said otherwise. The G6 and L3 were tied on this one, while the G7 never made that mistake.
Other observations: One of the complaints from users of the G7 has been that the glucose data is jumpier than they expected. Part of the reason for this is that the G6 and G7 software no longer back smoothes the historic data points, but there were occasions where I saw noticeable differences between the G6 and G7. There were times when the G7 data did appear to be quite jumpy, which wasn’t what I expected to see. However, before drawing too many conclusions about this, I intend to run another G7 to see whether this is consistent or just in relation to the back smoothing.
“I was surprised at the performance of the Libre 3. It produced a performance that was consistent with older versions of the Libre, in that it tended to measure on the lower side, but it was a lot closer to blood values than I expected. The data in this n=1 experiment suggested that it was the closest to fingerpricks without calibration. I’m interested to see whether that carries on across multiple sensors, as I know others have seen a much wider dispersion of values when compared to fingersticks.
The G7 was much more disappointing than I expected it to be. For what was supposed to be a more accurate version of the algorithm, the performance of the first four days was awful, and indeed, without calibration, I wonder what the results might have been. When I test the next G7, it will be done without any calibration.
Ultimately, for me, the key takeaway from this experiment is that anyone using the G7 should check the performance over the first few days, and if necessary, calibrate the sensor. It was an outcome that I was not expecting.”
Eli Lilly sees “unprecedented” demand for its diabetes drugs by Dulan Lokuwithana for SeekingAlpha.com, 6 December 2022.
Noticing an “unprecedented” demand, Eli Lilly is preparing for a “substantial expansion” of its manufacturing capacity for diabetes drugs around 2025, Fierce Pharma reported Tuesday, citing the company’s investor relations chief Joe Fetcher.
For diabetes patients, the Indianapolis, Indiana-based pharma giant markets injectable medicines Trulicity and Mounjaro. The latter is currently undergoing a Phase 3 trial for obesity, and a positive outcome will require the company to boost the manufacturing capacity further, subject to its regulatory clearance.
Late November, rival Novo Nordisk gained after the FDA cleared regulatory issues at two manufacturing sites employed by contract manufacturer Catalent to produce the company’s weight loss therapy Wegovy.
Read more: Eli Lilly sees “unprecedented” demand for its diabetes drugs
New Recommendations on CGM Use Published Worldwide: Time in Range by Natalie Sainz for diaTribe.org, 5 December 2022.
A new international consensus of recommendations for the standard use of continuous glucose monitoring (CGM) data in clinical trials have been published in The Lancet Diabetes & Endocrinology January issue. The consensus has been hailed as an essential step toward increasing the use of CGM metrics, including time in range, in clinical trials to advance potential breakthroughs in diabetes care.
The diaTribe Foundation, Advanced Technologies & Treatments for Diabetes (ATTD), and the Time in Range Coalition led this seven-month effort to achieve international agreement. In April 2022, the three organizations gathered 33 of the world’s top diabetes experts in Barcelona, Spain, to discuss these recommendations. “[This paper] is a big step forward in the field as we now have consensus on how to best assess and report on CGM data in clinical trials,” said Dr. Robert Gabbay, ADA’s chief science and medical officer.
The recommendations also cover the specific glucose metrics researchers should evaluate and report, information on clinically relevant changes in key glucose metrics over time, and training for both trial staff and participants. In total, 23 recommendations are included in the publication.
Read more: New Recommendations on CGM Use Published Worldwide
CVS Sued Over ‘Fraudulent’ Donations to American Diabetes Association by Guy DeMarco for LawStreetMedia.com, May 2022.
A consumer filed a class-action complaint in the Eastern District of New York against CVS Health Corporation for a purportedly deceptive charity campaign it held last year, which the plaintiff asserts was more like a reimbursement to CVS than a charitable donation.
According to the complaint, prior to the completion of a customer’s transaction, the checkout screen would prompt the customer with several boxes of pre-selected amounts (and an opt-out option) to donate to the American Diabetes Association (ADA). The plaintiff alleges that CVS did not merely collect the customer’s donations and forward them to the ADA, but instead, counted the donations toward a legally binding obligation of $10 million that CVS had made to the ADA.
In short, the plaintiff accuses the defendant of reimbursing itself with the charity donations. The plaintiff asserts that the defendant’s treatment of the charity donations was materially different from the untrue, deceptive, and misrepresented claim that CVS had given customers. The plaintiff seeks to represent a class consisting of the plaintiff “and all other persons who made a Campaign Donation,” which is purportedly in the thousands. CVS is accused of engaging in common-law fraud as well as violating consumer protection laws of the 50 states and the District of Columbia. The plaintiff seeks the following for relief: an award to the plaintiff and putative class members of disbursements, costs, damages, and relief.
Read more: CVS Sued Over ‘Fraudulent’ Donations to American Diabetes Association
The role of nurses in diabetes care: challenges and opportunities: The Lancet/Diabetes & Endocrinology, 29 November 2022.
With the global prevalence of diabetes set to increase over the coming decades from 537 million in 2021 to 783 million in 2045, solutions must be found to ensure that both prevention and treatment are guaranteed. A key component of this response will be the strengthening of health systems. Included in the overall health system response is the important role that human resources have in attaining the non-communicable disease-related and universal health coverage-related targets in the Sustainable Development Goals. In 2020, for the International Year of the Nurse and Midwife, the International Diabetes Federation called for more and better-trained nurses to address the challenges in diabetes prevention and care.
The requirement for a trained and qualified health workforce to address diabetes was stated in the 2021 World Health Assembly Resolution, entitled Reducing the burden of non-communicable disease through strengthening prevention and control of diabetes.
A quote attributed to Florence Nightingale states that “Nursing is a progressive art such that to stand still is to go backward.” Unfortunately, the global community has been standing still with regard to expanding the role of nurses in diabetes management in many low and lower middle income country contexts. This lack of action is a missed opportunity to complement medical science with the art of nursing to improve the health and well-being of people with diabetes.
Don’t Call Me ‘Dr’, Say Some Physicians — but Most Prefer the Title, by Amanda Loudin for Medscape.com, 23 November 2022.
When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.
“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”
Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”
The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.
“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time and an assumption of increased ease of access leading to this higher workload.”
Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”
WHAT DO YOU PREFER as a patient? If you are an HCP, DO YOU PREFER TO REMAIN TITLED?
Read more: Don’t Call Me ‘Dr’, Say Some Physicians — but Most Prefer the Title
I am disappointed by the performance of the G7 in early tests. Those who were in the early trial are saying that they noticed things as being better the longer thy used it The two I spoke with said they thought the sensor manufacturing got better.
I don’t know how that will resolve.
About CVS, I do not see CVS as doing much wrong. I did not read the entire agreement of course but I do not believe its practice is uncommon.
It will be fascinating to see how it shakes out. My prediction, we will not see much of this after past this point. Besides, what are the damages? Did the ADA file the suit? no. Was a customer harmed? I don’t see how. Were investors harmed? I do not think so.
Depending on the contract, I sense it will dismissed.