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Post by johnhindepost on Jul 21, 2016 14:32:10 GMT -5
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Post by peppy on Jul 21, 2016 14:34:53 GMT -5
Forgive my ignorance, but could a patient rent a CGM, for titration purposes? They would, of course, have to pay for the consumables used with the device. I've often wondered if more patients with Type 2 diabetes would consider using CGM's short-term when they initiate diabetes treatment if CGM's where available for rent, rather than shelling out the big $$$. I would think that 3rd-party payers would like this idea if it resulted in better control of the disease. I think the renting idea is basically what FreeStyle Libre Pro (currently under review by FDA) offers. Hope the same concept can be applied to regular CGMs. FreeStyle Libre Pro is a bit different from the patient version of FreeStyle Libre (available in Europe) that we tested in diaTribe in January. Libre Pro allows physicians to get continuous glucose data from patients over a two-week period. It consists of a small sensor (a bit larger than a US quarter dollar coin) worn on the arm. After applying Libre Pro in the doctor’s office, it is worn for two weeks, and the sensor automatically records glucose values every 15 minutes. Patients then return to the doctor’s office, where the sensor is downloaded. Abbott has done a really good job of making the glucose data download easy to interpret, meaning healthcare providers and patients can quickly grasp what is going well and what may need improvement. Unlike the FreeStyle Libre system currently available in Europe, the Pro version does not give patients a reader device to look at glucose values in real time. While that seems like an obvious drawback, it’s a key design choice for a few reasons: Many patients don’t want to wear a sensor all the time; wearing this product occasionally (i.e., twice a year) could offer many of the benefits of more continuous glucose monitoring (i.e., more comprehensive glucose data to change therapy), but without having to wear a sensor all the time.
Professional glucose monitoring systems like FreeStyle Libre Pro are generally reimbursed well by insurance, including Medicare. Medicare does not currently reimburse real-time CGM.
Many patients change their behavior in response to seeing the real-time data. A blinded sensor like FreeStyle Libre Pro makes it more likely patients will stick to their normal routine – allowing providers to get a more realistic view of a patient’s day to day management.
The FDA approval process for FreeStyle Libre Pro should be easier than the real-time version, since patients can’t make insulin dosing decisions off the blinded system. - See more at: diatribe.org/freestyle-libre-pro-submitted-fda-approval-potentially-coming-us-2016#sthash.VD3MIJqq.dpufNow we are cooking with cisco. A rental Continuous Glucose Monitor to learn dosing. Vdex will want the rental.
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Post by agedhippie on Jul 21, 2016 16:13:51 GMT -5
The roster of authorities sitting on the panel will work in Dexcom’s favor as well, Antallfy said, as it includes 6 endocrinologists and diabetes authorities, who the analyst thinks would “likely be more postively biased towards CGM.” When Dexcom's G5 CGM is approved as an FDA standard, what would be next for MannKind? Positive possibilities? People please share your domino effect hypotheticals... This is the approval the label change to say that the G5 as accurate enough to dose insulin with - the petition we just signed. The G5 was released last last year and Dexcom are in the process of getting the G6 approved for release early next year. |
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Post by dreamboatcruise on Jul 21, 2016 16:20:25 GMT -5
Forgive my ignorance, but could a patient rent a CGM, for titration purposes? They would, of course, have to pay for the consumables used with the device. I've often wondered if more patients with Type 2 diabetes would consider using CGM's short-term when they initiate diabetes treatment if CGM's where available for rent, rather than shelling out the big $$$. I would think that 3rd-party payers would like this idea if it resulted in better control of the disease. The Dexcom G5 will work with a smartphone as the receiver so it has lowered the cost from previous generations. It does require a transmitter in addition to the sensors. I found a retail price for the transmitter of $615. Not sure if that would be considered something that could be reused by a different patient. |
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Post by johnhindepost on Jul 21, 2016 16:23:39 GMT -5
us12.campaign-archive2.com/?u=7236e0997a63128cdf0b18b50&id=6d72be5628FDA's Advisory Committee meeting just voted to recommend approval of the expansion of the Dexcom G5 CGM label. The results are in and the FDA panel has voted the following for the labeling change of the Dexcom G5 Continuous Glucose Monitoring System: 1. Is there reasonable assurance that the Dexcom G5 Continuous Glucose Monitoring System is safe for the proposed indications of use? YES: 8 NO: 2 2. Is there reasonable assurance that the Dexcom G5 Continuous Glucose Monitoring System is effective for the proposed indications for use? YES: 9 NO: 1 3. Do the benefits of the Dexcom G5 Continuous Glucose Monitoring System for the proposed indications of use outweigh the risks of the Dexcom G5 Continuous Glucose Monitoring System for the proposed indications for use. YES: 8 NO: 2
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Post by cjc04 on Jul 21, 2016 16:41:19 GMT -5
UPDATE:::
Okay, I only try to post when it's relevant (I've managed to stay away when I'm blinded with frustration regarding our sp) and the update I just got from my wife fits perfectly here......
My wife wore one of these "blind" cgm devices 8 months ago before she started Afrezza. Her a1c was "great" at around 6.4, but I was watching her get up in the middle of the night with hypo's 3 or 4 times a week. I told her that if she had an a1c in the 6's with that many hypo's, then I guarantee she was spiking a lot and spending way too much time with bs levels in the 200's and 300's. Sure enough, the results of the blind CGM were frightening, ALL over the place, even hitting 400's. The chart was a mess of a roller coaster.
I've written the story before, but, she goes on Afrezza and only 8 weeks later tests with a 5.7 a1c and NO hypo's......
NOW, last week she wore the blind CGM again for 5 days. ***NOTE: (at the endo appt to have the device put on, he told her he had not prescribed A to anyone else because he didn't think it would be available). She just got the results back yesterday. Incredible, calm & steady. He's predicting an a1c of 5 or lower. She needs some adjustment, probably lower her long lasting dose, but she never went under 50 and only went over 150 three times, the highest being 180. THIS WAS BLIND!!!! No carb counting, no stressing, basically guessing on whether to take 4, 8, or 12 units based on what she ate.
her reluctant endo was so surprised at the blind CGM results, that he has prescribed Afrezza to another patient!!!
As for my personal frustration with the sp,,, I went to bed last night so happy with my wife's results and woke up just as happy feeling like the stock should be at $5.00 just because of her, of course it's not, just the same ol..... I really hope Matt & Mike can open the eyes of the health care system with results like my wife's before it's too late.
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Post by mannmade on Jul 21, 2016 16:43:33 GMT -5
Oh, but they are. Here is one example: Suzanne Stone - Worked for MannKind from 2003-2014 - Started working for Dexcom in 2014-present - She is currently the Senior Director of Sales Operation you missed the important one DEXCOM MANNKIND One starts with a D and the other ends with a D Well I guess if I were to play this game... and I guess I am... then forget Suzanne. Kevin Sayer, CEO used to work for Al as did his predecessor who is now Chairman of the Board and they both loved AL. Kevin is very aware of AFREZZA and what it can do. Having said this however, I would not put too much stock into it. They both have their own issues and need to sell their own product. A co-promotion of real time control might work for them together but also a potential disadvantage for Mnkd to be tied to one product in a newly emerging category imho.. My understanding is that Freestyle Libra for example is very big in Europe and Asia (Matt Bendall for example) and is coming to the States. |
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Post by mannmade on Jul 21, 2016 16:46:08 GMT -5
Forgive my ignorance, but could a patient rent a CGM, for titration purposes? They would, of course, have to pay for the consumables used with the device. I've often wondered if more patients with Type 2 diabetes would consider using CGM's short-term when they initiate diabetes treatment if CGM's where available for rent, rather than shelling out the big $$$. I would think that 3rd-party payers would like this idea if it resulted in better control of the disease. At this time I do not think so. |
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Post by lakers on Jul 21, 2016 17:45:28 GMT -5
www.massdevice.com/fda-panel-votes-favor-dexcom-g5-dosage-label-expansion/An FDA panel evaluating Dexcom’s G5 continuous glucose monitor seeking a non-adjuctive dosing claim voted in favor of the indication, with 8 votes for and 2 votes against. The panel voted on 3 separate questions during the evaluation. On whether or not there is reasonable assurance that the G5 is safe for its proposed indications for use, the panel returned 8 votes for and 2 against. The panel returned 9 votes in favor and 1 vote against when considering whether or not there is a reasonable assurance that the G5 is effective for the proposed indications, and 8 for and 2 against when asked whether the benefits of the G5’s proposed indications outweigh the risks, according to a Leerink Partners letter to investors. The company will have to wait to receive an official indication expansion from the FDA, but will do so now with the support of the panel vote. The new indication would allow the next-gen CGM to replace fingerstick blood glucose testing, as opposed to operating as complimentary to them. On Tuesday, the FDA released information for the panel as Dexcom sought the expanded indication for the G5 that would allow the next-gen CGM to replace fingerstick blood glucose testing, as opposed to operating as complimentary to them. The agency said that the accuracy of the G5 CGM was “close to, but not as good as, traditional self-monitoring blood glucose meters,” but touted that the G5 provides “contextual information and self-monitoring [that] self monitoring blood glucose meteres do not provide that may lead to users making more informed insulin dosing decisions,” according to the report. To support the use of the device under the new dosage labeling, Dexcom provided clinical data from trials of its G4 CGM, which uses an identical glucose sensor and algorithms. Reports from the device were found to be within 15% of standard blood sample readings in pediatric patients 81% of the time and for adult patients 86% of the time. The reports were within 20% in 91% and 93% of pediatric and adult patients respectively, and within 30% 96% and 98% of the time, respectively. “Significant numbers of Continuous Glucose Monitoring System users are believed to be currently using glucose values obtained from their Continuous Glucose Monitoring System devices (“off label” use) to make insulin dosing decisions. A significant barrier to these users making better, informed decisions using glucose data from their Dexcom G5 Continuous Glucose Monitoring System device is the labeling restriction currently in place that this device is only to be used adjunctively,” the FDA wrote in the prepared panel information.
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Post by lakers on Jul 21, 2016 17:55:52 GMT -5
Published Online: July 21, 2016 Mary Caffrey After hearing form supporters that included the chief medical officer of the American Diabetes Association (ADA) and a former Miss America, an FDA panel recommended Thursday that Dexcom’s G5 continuous glucose monitoring (CGM) system be approved for dosing insulin—a use that patients say are doing anyway. Adding a dosing indication to the Dexcom G5 would open the door for widespread patient and clinician training and education to help those with type 1 diabetes (T1D) or their parents, according to company officials and clinicians who spoke during the public hearing, held in Gaithersburg, Maryland. The meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel, which is a part of the Medical Devices Advisory Committee, voted in favor of all 3 questions put to it after a daylong hearing. Panel members voted 8-2 on the questions of whether the proposed new indication was safe and whether the benefits outweighed the risks. The panel voted 9-1 on the question of whether the CGM system was effective for its proposed new use. Recommendations now go to the full FDA. CGM uses a sensor and an algorithm fed to a receiver—or a smartphone—to take readings of blood glucose levels every 5 minutes around the clock and guide insulin dosing. Patients can set customized alerts to warn them when their blood glucose levels reach a high or a low level, and a built-in alarm goes off if a patient’s blood glucose reaches 55 mg/dL, a level that puts the person at risk of hypoglycemia and loss of cognitive function. Unlike self-monitoring of blood glucose (SMBG), Dexcom’s G5 system uses a combination of readings and trending arrows to tell patients if levels are rising or falling. If blood glucose levels are rapidly changing, that may indicate a different response than a SMBG tests that shows a reading above or below recommended levels. Dexcom's current approval requires SMBG for every insulin dose. Until recently, SMBG has been considered more accurate, but Dexcom, patients and several clinicians who spoke yesterday say the CGM technology has evolved to provide accuracy that is on nearly on par with a blood test and in many ways more useful. For these reasons, Dexcom began talks with FDA to discuss what information would be needed for a dosing indication. While the vast majority of those affected by the panel’s vote have T1D, an increasing number of persons with type 2 diabetes (T2D) could benefit from CGM, as the population ages and more seniors deal with the disease. As patients age, they are less likely to sense symptoms of hypo- or hyperglycemia, making CGM more critical. Because the technology is approved as “adjunctive” and not for dosing, Medicare considers it “precautionary,” and not necessary. Only a handful of patients have been able to appeal for coverage. This has been a point of great frustration for T1D patients; increasingly, they gain superior control with CGM and then lose access to the technology when they reach age 65. Brian Buckingham, MD, of Stanford, who presented information on Dexcom’s clinical utility, said CGM helps patients when they are most vulnerable: at night and when they are distracted. Most hypoglycemic events occur while patients are sleeping, when “finger testing is inadequate,” he said. - See more at: www.ajmc.com/newsroom/fda-panel-supports-using-cgm-for-insulin-dosing#sthash.tza31r2X.dpuf |
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Post by slugworth008 on Jul 21, 2016 18:59:37 GMT -5
Dexcom and Mannkind are not linked together in any way. Oh, but they are. Here is one example: Suzanne Stone - Worked for MannKind from 2003-2014 - Started working for Dexcom in 2014-present - She is currently the Senior Director of Sales Operations Outstanding find and post - Kudos !!! |
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Post by surplusvalue on Jul 21, 2016 19:45:19 GMT -5
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Post by Deleted on Jul 21, 2016 19:57:43 GMT -5
Castagna has already hinted to a co-promotion (didn't say specifically what/who) in an interview he did.
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Post by steve on Jul 21, 2016 20:55:29 GMT -5
VDEX is ready now. imho
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Post by LosingMyBullishness on Jul 22, 2016 10:45:14 GMT -5
Compare the 5y chart of Dexcom with MNKD. +470% vs -70 %. Well, that management did a great job for shareholders.
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