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Posts with tag FDA diabetes

I love you, you're perfect, now change

For more the more than 300,000 users that once relied on animal-derived insulin, the final chapter of animal insulin is finally ending for the US market. In December 2007, Novo Nordisk has officially decided to discontinue making animal-insulin. Their explanation doesn't go into great detail why they chose to discontinue it. But the supporting evidence they use to warrant the decision is a little weak.

Novo says, animal insulin is derived from the pancreas of slaughtered animals. This statement is as true as the statement "human insulin is derived from the pancreas of slaughtered humans". Novo continues, since that time there has been significant improvement of insulin quality and formulation. Absolutely true! In fact, a Novo pork product was shown to be greater than 99% pure, while an Eli Lilly human insulin only exceeded the 97 percentile. As a consequence, demand for these old animal insulins has declined by as much 20% in the last year to a point where approximately 2% of all insulin users are currently using these products. Largely due to the fact doctor's were advising their patients they must prepare to switch to GM insulin because animal-derived insulin would be nearly impossible to obtain. True. The research that introduced GM insulin (back in the 80s) was preemptive, at best. The claims supporting it was better than the existing insulin choices was clearly debatable .A telling similarity to the discovery about Avandia.

The long-term results of GM insulin and its analogs would prove to be a nightmare if the right questions were asked, and the data properly collected. Is it fair for any of the companies to ask us to change from an insulin product we have grown to love? No, but much like the off-Broadway play suggests: We love you (as a customer). Your diabetes is perfect (for our bottom line). Now change your insulin (we don't feel like making that kind anymore). Too bad type 1 diabetics forced to change to GM insulin didn't have the outspoken advocates like those taking Avandia.

Muscle for Rank in the Continuous Glucose Monitoring Market

In the next 3 to 5 years, we will have a new generation of control upon us providing continuous glucose monitoring. Some of these marvelous technologies will not require a drop of blood, while others will embody the tried-and-true stick-to-itiveness we all know and loathe.

Please join me as we browse the isles of things to come (and things now available) for continuous glucose monitoring.

The DexCom STS Continuous Glucose Monitoring System is a glucose sensor that reports glucose values every 5 minutes for up to 72 hours. The sensor is inserted in the abdomen. After a 2 hour start-up period, the STS System is calibrated with 2 fingerstick measurements taken by a traditional glucose meter. Checkout Amy Tenderich's review on Diabetes Mine of the DexCom Continuous Glucose Monitoring Sytem.

MiniMed Medtronic has 3 different versions: the Gold, the Guardian RT, and the Paradigm Real-Time Continuous Monitor.

Menarini GlucoDay S is a device worn by the patient for the continuous monitoring of glucose in the subcutaneous interstitial fluid. Monitoring is performed via insertion in the abdominal region of a microfibre for dialysis having the diameter of a human hair. Inside the microfibre a solution transports the patient's glucose to a biosensor within the instrument.

M-Biotech Glucose Biosensor is a minimally invasive implantation for painless and convenient monitoring. The key feature of our efficient Glucose Biosensor is the combination of a glucose-sensitive hydrogel and a miniature pressure sensor. Glucose-responsive hydrogels are biocompatible materials that either swell or contract when the glucose concentrations change in the body fluid surrounding the hydrogel.

The PreciSense System includes a microcapsule placement unit and a light detecting non-invasive reader unit. The microcapsule placement unit poses the right dose of glucose-responding microcapsules in the upper layer of the skin, painlessly. The glucose assay components in the microcapsules generate a fluorescence signal that corresponds to the glucose level. The non-invasive reader unit monitors this glucose binding event through FRET, Fluorescence Resonance Energy Transfer, which is directly related to the concentration of glucose.

Sensors for Medicine and Science glucose sensor is implanted under the skin in a short outpatient procedure. The sensor automatically measures interstitial glucose every few minutes, without any user intervention. The sensor implant will communicate wirelessly with a small external reader.

Synthetic Blood Implanted Glucose Biosensor claims to offer significantly more accurate glucose readings in a range of 30-500 mg/dl. The implanted Glucose Biosensor continuously monitors blood glucose without the need for finger sticks. The most accurate glucose monitor available, the implanted biosensor can be programmed to monitor blood glucose according to a predetermined schedule, thus eliminating problems of patient compliance. The sensor alarms for dangerous, life threatening conditions such as hypoglycemia.

GlucoLight Corporation is developing a low-cost non-invasive blood glucose monitor for home use by diabetic patents. GlucoLight's unique optical approach, microScatterTM (microscatter) technology, is based on patented technologies in the area of Optical Coherence Tomography (OCT) and Low Coherence Interferometry (LCI). There is a working prototype with published clinical data on healthy volunteers.

The GlucoWatch G2 Biographer was approved to detect glucose level trends and track patterns in people with diabetes. It must be used along with conventional blood glucose monitoring of blood samples. The device, which looks like a wristwatch, pulls body fluid from the skin using small electric currents. It can provide six measurements per hour for 13 hours. (See David Mendosa's review).

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