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Post by jlaw277 on Mar 20, 2018 9:07:40 GMT -5
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Post by jlaw277 on Mar 20, 2018 9:33:09 GMT -5
Maturation of CGM and Glycemic Measurements Beyond HbA1c—A Turning Point in Research and Clinical Decisions
Another exciting possibility is that CGM can be used as an outcome measure in clinical trials. Up until now, comparisons of hypoglycemic risks in clinical trials have been limited by the fact that many events are unrecognized and therefore not reported by the patient. Documentation of unrecognized events in trials depends on the frequency and timing of glucose testing, which may differ between randomized groups, introducing bias in assessing the true incidence and rate of events. A particular problem concerns the use of 6-, 7-, or 8-point self-measured glucose profiles to assess preprandial, postprandial, and overnight patterns and the frequency of events. Because few people eat their meals at the same time each day, the results of these standardized profiles may bear little relation to a patient’s actual day-to-day patterns. Continuous measurement of glucose eliminates this problem and additionally reveals between-day differences as well as within-day patterns of glycemia. Availability of better data regarding these research questions may facilitate regulatory evaluation of new therapies and may support constructive changes in guidelines for management. ====== There is a lot of interesting unlocked info in this issue of Diabetes Care
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Post by hellodolly on Mar 20, 2018 10:16:43 GMT -5
Maturation of CGM and Glycemic Measurements Beyond HbA1c—A Turning Point in Research and Clinical Decisions
Another exciting possibility is that CGM can be used as an outcome measure in clinical trials. Up until now, comparisons of hypoglycemic risks in clinical trials have been limited by the fact that many events are unrecognized and therefore not reported by the patient. Documentation of unrecognized events in trials depends on the frequency and timing of glucose testing, which may differ between randomized groups, introducing bias in assessing the true incidence and rate of events. A particular problem concerns the use of 6-, 7-, or 8-point self-measured glucose profiles to assess preprandial, postprandial, and overnight patterns and the frequency of events. Because few people eat their meals at the same time each day, the results of these standardized profiles may bear little relation to a patient’s actual day-to-day patterns. Continuous measurement of glucose eliminates this problem and additionally reveals between-day differences as well as within-day patterns of glycemia. Availability of better data regarding these research questions may facilitate regulatory evaluation of new therapies and may support constructive changes in guidelines for management. ====== There is a lot of interesting unlocked info in this issue of Diabetes Care You learn something new everyday. Am I reading that most clinical trials for diabetes drugs don't allow patients to use CGM's? |
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Post by agedhippie on Mar 20, 2018 10:29:31 GMT -5
Maturation of CGM and Glycemic Measurements Beyond HbA1c—A Turning Point in Research and Clinical Decisions
Another exciting possibility is that CGM can be used as an outcome measure in clinical trials. Up until now, comparisons of hypoglycemic risks in clinical trials have been limited by the fact that many events are unrecognized and therefore not reported by the patient. Documentation of unrecognized events in trials depends on the frequency and timing of glucose testing, which may differ between randomized groups, introducing bias in assessing the true incidence and rate of events. A particular problem concerns the use of 6-, 7-, or 8-point self-measured glucose profiles to assess preprandial, postprandial, and overnight patterns and the frequency of events. Because few people eat their meals at the same time each day, the results of these standardized profiles may bear little relation to a patient’s actual day-to-day patterns. Continuous measurement of glucose eliminates this problem and additionally reveals between-day differences as well as within-day patterns of glycemia. Availability of better data regarding these research questions may facilitate regulatory evaluation of new therapies and may support constructive changes in guidelines for management. ====== There is a lot of interesting unlocked info in this issue of Diabetes Care You learn something new everyday. Am I reading that most clinical trials for diabetes drugs don't allow patients to use CGM's? If the primary measure is HbA1c reduction why would you need a CGM (or a meter for that matter)? I doubt that a trial would not allow anyone to use a CGM though. |
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Post by Deleted on Mar 20, 2018 11:21:58 GMT -5
You learn something new everyday. Am I reading that most clinical trials for diabetes drugs don't allow patients to use CGM's? If the primary measure is HbA1c reduction why would you need a CGM (or a meter for that matter)? I doubt that a trial would not allow anyone to use a CGM though. A1c used to be the benchmark but it will go the way of the buggy whip. Before home blood glucose testing way back when diabetics used to test their urine for glucose at home. Problem with the urine test is that the blood glucose levels had to get so high before excess glucose spilled into the urine and by the time the patient did the urine test, the elevated blood glucose situation had likely come and gone so kind of like the weather reporter telling you about yesterdays rain. Anyone remember Lilly Testape or Ames Clinitest? A1c is merely an average and does not speak to the swings in blood glucose levels either hyper or hypoglycemia and it is these wide swings in glucose levels that cause the long term health complications that if left unchecked, will bankrupt the US healthcare system. Obesity in the next decade or so will reach 50% of the US population. Once upon a time, A1c was the best measurement tool patients and healthcare practitioners had but that is obviously changing due to CGMs. By the end of 2019 DexComm will have a nickel sized sensor that will transmit CGM data directly to a smartphone and from there, it will get sent to Verily's database for evaluation and storage. This new small sensor will be widely available at retail pharmacies. Once the insurance companies start to pay for time in range vs pills, insulin and blood glucose test strips the paradigm (hate that word) changes. You see, the cost of treating retinopathy, neuropathy and nephropathy along with the slew of other health complications diabetics suffer (CV, wound care, amputation) makes the cost of pills chump change vs the cost of treating these diabetes related health complications. |
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Post by peppy on Mar 20, 2018 11:36:02 GMT -5
If the primary measure is HbA1c reduction why would you need a CGM (or a meter for that matter)? I doubt that a trial would not allow anyone to use a CGM though. A1c used to be the benchmark but it will go the way of the buggy whip. Before home blood glucose testing way back when diabetics used to test their urine for glucose at home. Problem with the urine test is that the blood glucose levels had to get so high before excess glucose spilled into the urine and by the time the patient did the urine test, the elevated blood glucose situation had likely come and gone so kind of like the weather reporter telling you about yesterdays rain. Anyone remember Lilly Testape or Ames Clinitest? A1c is merely an average and does not speak to the swings in blood glucose levels either hyper or hypoglycemia and it is these wide swings in glucose levels that cause the long term health complications that if left unchecked, will bankrupt the US healthcare system. Obesity in the next decade or so will reach 50% of the US population. Once upon a time, A1c was the best measurement tool patients and healthcare practitioners had but that is obviously changing due to CGMs. By the end of 2019 DexComm will have a nickel sized sensor that will transmit CGM data directly to a smartphone and from there, it will get sent to Verily's database for evaluation and storage. This new small sensor will be widely available at retail pharmacies. Once the insurance companies start to pay for time in range vs pills, insulin and blood glucose test strips the paradigm (hate that word) changes. You see, the cost of treating retinopathy, neuropathy and nephropathy along with the slew of other health complications diabetics suffer (CV, wound care, amputation) makes the cost of pills chump change vs the cost of treating these diabetes related health complications. The cynic here says, HbA1c the tool of Pharma. A simple measure done quarterly, used to start the diabetic therapy. Give human beings as little information as possible and tell them they need a pill, or multiple pills, or injection. The recipe perfected in the standards of care. www.screencast.com/t/ctNezsoO9Derek told us with the libre he could see that his standard breakfast choice needed adjustment. Don't ask me what I think of PSA's. Because I'll tell you. |
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Post by digger on Mar 20, 2018 23:24:08 GMT -5
If the primary measure is HbA1c reduction why would you need a CGM (or a meter for that matter)? I doubt that a trial would not allow anyone to use a CGM though. A1c used to be the benchmark but it will go the way of the buggy whip. Before home blood glucose testing way back when diabetics used to test their urine for glucose at home. Problem with the urine test is that the blood glucose levels had to get so high before excess glucose spilled into the urine and by the time the patient did the urine test, the elevated blood glucose situation had likely come and gone so kind of like the weather reporter telling you about yesterdays rain. Anyone remember Lilly Testape or Ames Clinitest? A1c is merely an average and does not speak to the swings in blood glucose levels either hyper or hypoglycemia and it is these wide swings in glucose levels that cause the long term health complications that if left unchecked, will bankrupt the US healthcare system. Obesity in the next decade or so will reach 50% of the US population. Once upon a time, A1c was the best measurement tool patients and healthcare practitioners had but that is obviously changing due to CGMs. By the end of 2019 DexComm will have a nickel sized sensor that will transmit CGM data directly to a smartphone and from there, it will get sent to Verily's database for evaluation and storage. This new small sensor will be widely available at retail pharmacies. Once the insurance companies start to pay for time in range vs pills, insulin and blood glucose test strips the paradigm (hate that word) changes. You see, the cost of treating retinopathy, neuropathy and nephropathy along with the slew of other health complications diabetics suffer (CV, wound care, amputation) makes the cost of pills chump change vs the cost of treating these diabetes related health complications. Dexcom has a problem similar to MNKD, they need to prove that using their product will widen insurers profit margins. Measuring A1c is a generally accepted standard and more importantly it is cheap. |
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Post by agedhippie on Mar 21, 2018 9:58:59 GMT -5
By the end of 2019 DexComm will have a nickel sized sensor that will transmit CGM data directly to a smartphone and from there, it will get sent to Verily's database for evaluation and storage. This new small sensor will be widely available at retail pharmacies. Once the insurance companies start to pay for time in range vs pills, insulin and blood glucose test strips the paradigm (hate that word) changes. You see, the cost of treating retinopathy, neuropathy and nephropathy along with the slew of other health complications diabetics suffer (CV, wound care, amputation) makes the cost of pills chump change vs the cost of treating these diabetes related health complications. First down a bit of a rabbit hole... I think the problem with the nickel sized sensor is going to be the battery. If you look at the Dexcom sensor today the bulk of the sensor is taken up with the holder for the transmitter and the sensor proper is in the subcutaneous fat. The Dexcom transmitter, I suspect specifically the larger battery to cope with the bluetooth drain, is the big object. With the G4/5 Dexcom made the transmitter larger and halved the battery life from the Dexcom Seven. I don't see how they get this to $10 retail, sensors today without any electronics or smarts are over $30. Now to time in range. Analysis of the DCCT study showed that only 11% of the risk of microvascular complications is due to absolute glucose level (HbA1c) and, while there is some debate, it seems probable that fluctuation may be a major contributor to the missing 89%. The insurers are not going to pay to mitigate this risk because it's years away and statistically you are unlikely to be their problem when complications strike. |
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Post by peppy on Mar 21, 2018 10:12:15 GMT -5
By the end of 2019 DexComm will have a nickel sized sensor that will transmit CGM data directly to a smartphone and from there, it will get sent to Verily's database for evaluation and storage. This new small sensor will be widely available at retail pharmacies. Once the insurance companies start to pay for time in range vs pills, insulin and blood glucose test strips the paradigm (hate that word) changes. You see, the cost of treating retinopathy, neuropathy and nephropathy along with the slew of other health complications diabetics suffer (CV, wound care, amputation) makes the cost of pills chump change vs the cost of treating these diabetes related health complications. First down a bit of a rabbit hole... I think the problem with the nickel sized sensor is going to be the battery. If you look at the Dexcom sensor today the bulk of the sensor is taken up with the holder for the transmitter and the sensor proper is in the subcutaneous fat. The Dexcom transmitter, I suspect specifically the larger battery to cope with the bluetooth drain, is the big object. With the G4/5 Dexcom made the transmitter larger and halved the battery life from the Dexcom Seven. I don't see how they get this to $10 retail, sensors today without any electronics or smarts are over $30. Now to time in range. Analysis of the DCCT study showed that only 11% of the risk of microvascular complications is due to absolute glucose level (HbA1c) and, while there is some debate, it seems probable that fluctuation may be a major contributor to the missing 89%. The insurers are not going to pay to mitigate this risk because it's years away and statistically you are unlikely to be their problem when complications strike. aged or all, do you know what makes the libre receiver different? |
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Post by agedhippie on Mar 21, 2018 10:35:40 GMT -5
First down a bit of a rabbit hole... I think the problem with the nickel sized sensor is going to be the battery. If you look at the Dexcom sensor today the bulk of the sensor is taken up with the holder for the transmitter and the sensor proper is in the subcutaneous fat. The Dexcom transmitter, I suspect specifically the larger battery to cope with the bluetooth drain, is the big object. With the G4/5 Dexcom made the transmitter larger and halved the battery life from the Dexcom Seven. I don't see how they get this to $10 retail, sensors today without any electronics or smarts are over $30. Now to time in range. Analysis of the DCCT study showed that only 11% of the risk of microvascular complications is due to absolute glucose level (HbA1c) and, while there is some debate, it seems probable that fluctuation may be a major contributor to the missing 89%. The insurers are not going to pay to mitigate this risk because it's years away and statistically you are unlikely to be their problem when complications strike. aged or all, do you know what makes the libre receiver different? The Libre uses NFC for communications so it doesn't need to power a bluetooth transmitter. There are bolt-on options like blucon to swipe and transmit the data to your phone every five minutes so the Libre effectively becomes a CGM. |
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Post by dreamboatcruise on Mar 21, 2018 10:47:06 GMT -5
By the end of 2019 DexComm will have a nickel sized sensor that will transmit CGM data directly to a smartphone and from there, it will get sent to Verily's database for evaluation and storage. This new small sensor will be widely available at retail pharmacies. Once the insurance companies start to pay for time in range vs pills, insulin and blood glucose test strips the paradigm (hate that word) changes. You see, the cost of treating retinopathy, neuropathy and nephropathy along with the slew of other health complications diabetics suffer (CV, wound care, amputation) makes the cost of pills chump change vs the cost of treating these diabetes related health complications. First down a bit of a rabbit hole... I think the problem with the nickel sized sensor is going to be the battery. If you look at the Dexcom sensor today the bulk of the sensor is taken up with the holder for the transmitter and the sensor proper is in the subcutaneous fat. The Dexcom transmitter, I suspect specifically the larger battery to cope with the bluetooth drain, is the big object. With the G4/5 Dexcom made the transmitter larger and halved the battery life from the Dexcom Seven. I don't see how they get this to $10 retail, sensors today without any electronics or smarts are over $30. Now to time in range. Analysis of the DCCT study showed that only 11% of the risk of microvascular complications is due to absolute glucose level (HbA1c) and, while there is some debate, it seems probable that fluctuation may be a major contributor to the missing 89%. The insurers are not going to pay to mitigate this risk because it's years away and statistically you are unlikely to be their problem when complications strike. I believe the G5 is based on classic Bluetooth technology. There is now a low energy version that is a significant advance in reducing the required battery size for applications just like this that require very modest amounts of data to be transmitted (compared to audio, the original purpose of bluetooth). To me (worked in wireless tech industry for much of my career) it seems plausible to have something roughly the size being proposed... nickle sized but thicker. As for sensor cost, it likely could be driven down considerably with higher production volumes. As for insurance payment I agree that insurers are not going to get out ahead with regard to trying to avoid long term complications due to exactly what you say. However, if solid science comes out showing how CGMs can significantly reduce reduce long term complications and advocacy groups like ADA get behind demanding insurance make them available, I think payers can be pressured into doing it even if it doesn't benefit them financially in the short term. It's not going to happen over night though. |
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Post by agedhippie on Mar 21, 2018 14:12:13 GMT -5
As for insurance payment I agree that insurers are not going to get out ahead with regard to trying to avoid long term complications due to exactly what you say. However, if solid science comes out showing how CGMs can significantly reduce reduce long term complications and advocacy groups like ADA get behind demanding insurance make them available, I think payers can be pressured into doing it even if it doesn't benefit them financially in the short term. It's not going to happen over night though. ADA can make the insurers cover CGMs by making it part of the Standard of Care. That's what they did in the end with pumps after years of obstruction by the insurers. The STAT study is interesting, but there needs to be a study to prove that time in range matters. Without that it's going to take a long time to gain traction. A comparison would be CGMs - for years insurers would not cover them even though everyone knew they made sense. It was only after Kaiser bit the bullet and sponsored a large scale trial that it became indisputable (at which point the insurers tried moving to prior authorization and step therapy to limit cover). Same thing when pumps came out. |
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Post by agedhippie on Mar 21, 2018 14:17:56 GMT -5
I believe the G5 is based on classic Bluetooth technology. There is now a low energy version that is a significant advance in reducing the required battery size for applications just like this that require very modest amounts of data to be transmitted (compared to audio, the original purpose of bluetooth). To me (worked in wireless tech industry for much of my career) it seems plausible to have something roughly the size being proposed... nickle sized but thicker. As for sensor cost, it likely could be driven down considerably with higher production volumes. The transmitter is BLE, but I am not sure exactly which version though. |
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Post by digger on Mar 21, 2018 21:58:14 GMT -5
As for insurance payment I agree that insurers are not going to get out ahead with regard to trying to avoid long term complications due to exactly what you say. However, if solid science comes out showing how CGMs can significantly reduce reduce long term complications and advocacy groups like ADA get behind demanding insurance make them available, I think payers can be pressured into doing it even if it doesn't benefit them financially in the short term. It's not going to happen over night though. ADA can make the insurers cover CGMs by making it part of the Standard of Care. That's what they did in the end with pumps after years of obstruction by the insurers. The STAT study is interesting, but there needs to be a study to prove that time in range matters. Without that it's going to take a long time to gain traction. A comparison would be CGMs - for years insurers would not cover them even though everyone knew they made sense. It was only after Kaiser bit the bullet and sponsored a large scale trial that it became indisputable (at which point the insurers tried moving to prior authorization and step therapy to limit cover). Same thing when pumps came out. According to this fairly recent article, insurers still require a letter of medical necessity -- insulinnation.com/treatment/how-to-get-approved-for-pump-therapy/ |
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Post by brotherm1 on Mar 22, 2018 5:41:57 GMT -5
ADA can make the insurers cover CGMs by making it part of the Standard of Care. That's what they did in the end with pumps after years of obstruction by the insurers. The STAT study is interesting, but there needs to be a study to prove that time in range matters. Without that it's going to take a long time to gain traction. A comparison would be CGMs - for years insurers would not cover them even though everyone knew they made sense. It was only after Kaiser bit the bullet and sponsored a large scale trial that it became indisputable (at which point the insurers tried moving to prior authorization and step therapy to limit cover). Same thing when pumps came out. According to this fairly recent article, insurers still require a letter of medical necessity -- insulinnation.com/treatment/how-to-get-approved-for-pump-therapy/ Digger, January 2016 is not fairly recent. |
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