Replies to This Discussion

Permalink Reply by Kimberly on March 25, 2011 at 2:58pm

And I totally just ended my day w/ a good laugh. Thanks for that Jim!

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Permalink Reply by Jim Devlin on March 25, 2011 at 3:15pm

Your welcome!

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Permalink Reply by Janice on March 25, 2011 at 5:30pm

Interesting post. Actually, whether or not one complains to the FDA about this device, they are looking at it anyway this year. The reason for more scrutiny is that previously the company did not reveal problems they were having and were hiding information about the device. I found this out from Dr. Raymond Brullo at the FDA. Apparently he thinks it is reallly a question of the software having "glitches" and that is the issue with some of the readings being off.

If the Dexcom works for some, good for you. It may be that it is not for everyone. I have been very fortunate in that I have been able over the years to detect other warning signs of hypoglycemia, because I know myself VERY well, and I can tell when I need to check my blood sugar or eat something. I have not had a severe hypoglycemic episode for at least 3 years. Thank God.

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Permalink Reply by jims on March 25, 2011 at 6:43pm

janice:

Thank you for posting and the comments you indicate from other source are very germaine and match my suspicions as a hardware engineer designer.

I actually think the unit has lots of promise and a good start. As I said whne I have it corraled and working and tracking the hanhelds; I gewt extremely useful necessary information I cannot get from handhelds and necessary for good control.

I am glad I gave everyone a laugh today and realize my insulin use of humolog regular of 4 units at breakfast; 0 to 3 units at lunch - typically and 0 to 2.5 (typically 1.5 units at dinner seem a joke.

it was not always that way. The story is as follows:

diagnosed as type 2 in 1985 and put on early drugs including glucotrol.
had stroke in 2007 DEC from not properly watching and controlling. Had stopped all the candies, treats, extra sugars etc but not sufficient. Tried to log numbers in those days but were all over the place.

After stroke; found a1c at 13.3; morning numbers at 238 and higher and liver dumps during day
were 278 to 311 or higher. Eyes had retina hemorages, body full of water; kidneys taking a hit, scotum like cannon ball full of water - confirmed by catscan - not intestine in sack.
Lungs and breathing down.

Discovered in 2008 that at evening BG could be 100; at 3:00am was 150 and in am 238 or higher.

I was on that drug actos that will cram more sugars in your cells. At one point it was only drug getting BG down in am. 26 units of 75/25 had no impact till I walked 2 miles ( 1.5 min and 2 regularly and then BG would shoot down.

Whole year walked 2 miles every day and searched out and ask for help. Only help was comments on web that met stops it. WE noticed that every time met pill 500 mg up to strength in blood; liver stopped piping out sugar. a pill at 10:00pm and 12:00 am and my body stops liver dawn effect reliably from Midnight through 5:00 am. I wake up and take insulin shot and next met pill and this shuts down any further dawn sugaring attempts.

I also take a 500mg charge 1 hour before each meal as this cuts back liver make sugar nonsense. One large daily charge of metformin is useless and waste of pills. I have tested that.

We now had our BG down to a 155 daily average in Novemer 2010 with A1c of 6.9 %
My retina's healed up and hemorages gone both eyes. Lungs healed. Body excess water stopped and legs stopped weeping fluid and actos booted out.

A month ago I found I could start walking faster around my condo complex and started having super lows - CGM rang fire bells down We ended up booting all starlex. 75/25 was far too strong and active having a 12 hour live time.

Doctor changed out with regular humolog lispro ( 5 hours) with a 10/10/10 charges for meals.
That lasted a week and I am down to 4 units in am and about 1.5 at lunch and 1.5 at dinner and 15 units of Lantus at night. This keeps things flat at night.,

God knows what turned my pancreas back on but now when I start eating; I see my BG drop as pancreas is adding bolous. I wait till BG peak to see if I need to add a boost or not.

I also take all the recommended vitamin supplements that I consider safe bet.

Metformin is still on full bore as I see no evidence that lantus shot for bazal insulin does not stop the liver sugaring nonsense - only metformin.

Getting liver glucose add shutdown has let me lose weight and get far healthy. This has been 4 years beating on this monster.

A working CGM is critical to stay in control and catch timing and nonsense. Oh yes do not drink hard liqiuor whne on metformin; it counteracts met and makes liver dumps far worse.

Oh, yes liver day dumps seemed to be caused by excess insulin wandering around and stomach emptying and then reloading. Met stops . Actual value of BG 140 to 200 doesn't seem to matter, as liver will dump under condition noted and no met on duty.

Today; I am glad this has provided some laughs; it wasn't that way a few years ago - it was matter of life and death.

Oh yes, I was on 1200 calorie diet which while critical seemed to have no impact till liver shenanigans shutdown.

Key issues - heraty exercise - 1 to 2 miles a day. Tight diet and carbs handcuffed under control. Metformin where necessary and a safe bet on vitamin supplements.

Oh yes before stroke I had very stressful job and a blood pressure system hooked directly to my brains emotion. AT time of stroke - blood pressure was 210 and prior was regularly 160 to 190..

As for dexcom, what can I say - one more pain in the ass managing to keep life rolling. I hate it every time I have to shut down for two hours plus 3 extra getting CGM back up.
Like I said when it works and track I save strips and keep cool as BG rolls along smoothly.

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Permalink Reply by Jim Devlin on March 25, 2011 at 7:27pm

Hypoglycemic unawareness is a condition frequently developed over several decades by long time T1 diabetics. Sometimes this doesn't take as long.
After 59 years I have almost no warning signs. Unconscious within 10-15 minutes.
I have tested my glucose at 39 mg/dl.
I calibrate my Dexcom7 3-4 times per day. I have not, however, had a low sugar condition since I started using the CGM 14 months ago. Previously they were frequent. 1-3 times per month.
All this to keep a low A1h. My last test was 6.3%.
How I wish for just a day to be able to forget about diabetes.
I'm sick of it, but I accept the challenge.

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Permalink Reply by jims on March 25, 2011 at 9:38pm

jim d.

thank you for all the excellent comments and sharing. you make many good points. without cgm hard to control lows. with cgm I am able to grab. I only had some hypoglycemic awareness back in 1990's. Today, nope. Best i get is heat generation of my body when bg is 140 plus. half my body on ;left side has no temp sense. left hand like terminator 2. i have to precheck with right hand left hand when picking up ice cube fells like warm block sitting outside. From stroke in lizard brain in back of head.

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Permalink Reply by Janice on March 26, 2011 at 3:13pm

Jim D., I agree with you wholeheartedly about being sick of diabetes and wanting to forget about it for a day. Wouldn't it be wonderful to put it in a closet on a shelf for a while and forget about it? If only it were that easy.....sigh...

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Permalink Reply by jims on March 27, 2011 at 8:51am

I agree but with following comments:

What economics are we talking about?

As a 40 year designer, poorly tested equipment especially on medical gear that is supposed to be built and tested to rigorous standards is not excuseable in medical environment.

I too appreciate a CGM and only request it be properly tested and if there are issues; there should be a place for support comments and a response and user work arounds for now. NOT STONY silence..

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Permalink Reply by Tess on March 25, 2011 at 8:14pm

I disagree with you.If no one complains when they are having problems how are they going to make there product better.I am glad it is working so good for you but people are having trouble and should go to all ends to be able to fix these problems.

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Permalink Reply by Jim Devlin on March 25, 2011 at 9:32pm

Learn just a little about Economics, Tess.

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Permalink Reply by jims on March 25, 2011 at 9:41pm

Tess:

thank you for writing. Greatly appreciated. Everybody should have this data tool on their starship enterprise control panel. otherwise flying blind except when control systems work well and correctly.

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Permalink Reply by Rickst29 on March 28, 2011 at 4:29pm

Hey Jim, let's discuss a few bits (in order).

Sensor not reporting properly after inserting new sensor and waiting for 2 hours. Readings are bad until at least another 3 hours. This has repeated on each new sensor.

This is very common, and has a widely-used solution among Dex users on this board: Shoot in your "new, replacement" Sensor many hours BEFORE you make your switch. Several people do this overnight, and then execute the "Sensor Stop" - "Swap Transmitter into the New One" - "Sensor Start" sequence the following morning. Have you tried this already?

I have had unit receiver unit swapped out by dexcom and second unit works worse.
Receiver Unit overheats inside and flatlines. Chilling it back down stops that and unit recovers.... FDA says get a 3rd unit dexcom receiver and try. Did request weeks ago - no success. Dexcom not sent requested 3rd unit. FDA could care less.

You and I agree that Dexcom should replace it. Did you warn them that you will send an additional, future letter of complaint to the FDA if they don't agree to send you a functional unit, accepting the failed unit for analysis under your failing conditions (i.e., warm room)?

Without a specific threat of FUTURE action by you, they might be looking at your record of previous CS contacts.... and responding by putting you on the "back burner". (Not as a matter of policy, just a bad habit which developed over time.)

Unit misses faster cycles of BG due to pancreas activity and over smoothes data.

The way you wrote this statement hurts your credibility (if written to someone like me, or to the FDA). Unless you have both the microcode source AND an adequate set of raw datastream versus "true" bG values, you can't analyze whether they're "over-smoothing" or not. (Report what you know: the "missed" changes versus properly performed fingerstick measurements. Don't make a mess of your letter by gooping it up with unqualified guesses.)

Sitting in Condo - many times receiver has wondered off track with 20 to 30 points off - requiring loading cal BG's frequently. This unit was supposed to reduce finger pricks and costs - not so, I am constantly cross checking this flake product.

I'm with Jim Devlin on this one: If you're expecting to be within 20 points when you're watching TV, or otherwise "hanging around" (without the kind of SC blood flow you have while walking around), you need to poke for it. You can NEVER trust a current-technology CGMS to replace fingersticks, and all the documentation says so.

If you feel unsure of your bG status, you must fingerstick. Always.

I have contacted FDA without any success or assistance. I do not know who these folks are protecting? Not me and not the 13 folks killed on a PQQ technology BG handheld meter and strips in hospital setting.

PQQ is irrelevant to CGMS. Avandia is irrelevant to CGMS. If you want to see improvements in this technology, then you probably should not pour a bunch non-relevant disasters into a big tar-bucket, and then associate CGMS with those mistakes.

To answer your question: I feel that the FDA protects itself first. I seems to me that approving a treatment (or, in our case, a diagnostic) is usually more dangerous than letting it quietly fail under the economic pressure of increasingly excessive study data requests. The FDA, IMO, also appears vindictive and back-biting: AFAIK, the frequency of "broken wire" problems would be vastly less in the now-cancelled Gen-4 version, because the newly designed wire of the matching Sensor itself is 8x as strong. (The current "fix", AFAIK, is only a bunch of documentation, things which I'll paraphrase as being like "don't DARE use it off-label in children" and "If you suspect that a portion of the wire was left in your body during Sensor removal, see you M.D. immediately."

I don't know what "additional questions" FDA had WRT the Gen-4 approval request, but it resulted in two decisions by Dexcom: First, Gen-4 was completely cancelled. With a wire claimed to be 8x stronger, and accuracy claimed to be at least somewhat "better", are Dexcom-using PWDs really "more safe", stuck with using the 7-plus for at least two more years? And second, the Gen-5 device will be submitted for approval to the EU first, and brought to the USA much later. Dexcom apparently anticipates too much expense, and too many hassles, and perhaps too much delay, in getting approval here first.

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