Low Glucose Suspend – FDA Guidance

While complications of diabetes are understood and have been tied to the cost of providing healthcare, trends indicate the incidence Diabetes Mellitus in the United States and other developing countries is growing at an alarming rate.

There is so much about diabetes that is understood, predicted and recommended and yet management continues to be a challenge.  Could it be that better tools are needed?

To meet the challenge, researchers have been developing technology based tools that will help manage the disease through automation. That is, automatically administering an appropriate amount of insulin in response to a person’s glucose level and carbohydrate intake.

Often called the “artificial pancreas”, such systems combine continuous glucose measurement systems (CGM), insulin pumps (giving continuous subcutaneous insulin infusion) and advanced algorithms to give insulin dosing recommendations and stop infusion when a hypoglycemic event is predicted. The latter is called a “low glucose suspend” (LGS) device and provides benefit as a result of its autonomous action aimed at avoiding low blood sugar (predictively) or reducing the impact of hypoglycemia in a reactive manner.

Yesterday, the FDA release a new guidance document that will help medical device manufacturers submit their artificial pancreas-like product for review. The move is encouraging for a number of reasons. First, the agency is agreeing that automation has a role in the marketplace and is encouraging a path forward. Second, progress has been made and interest expressed to the point that the FDA felt is necessary to invest in guidance.

On the other-hand, there are a number of challenges the agency suggests must be remedied involving CGMs:

  • Using the same CGM to measure success and to make decisions about if and when to turn the pump off will introduce bias. Although the size of the bias may or may not be large, determining the extent of the bias will be impossible without an independent measure.
  • Although CGMs have been successful in improving diabetes management through their tracking and trending functions, these devices have not been shown to be accurate enough to support use for insulin dosing.
  • The glucose meters used to calibrate the CGMs also have inaccuracies that can compound the errors in the glucose values reported by the CGM and are part of the device system.
  • Use of retrospective signal calibration using reference blood glucose values or introducing a reference method to be performed by the patients may be possible solutions if the approach is appropriately validated.
  • CGMs have periods of sensor irregularities and signal drop out. These sensor performance problems arise in addition to sensor accuracy challenges and would need to be resolved and/or mitigated.

But are they effective enough to “pause” an insulin infusion?  Perhaps, but what if users begin to rely on a “pause” as their safety net even though CGMs have the issues listed above?

From an altruistic standpoint, advances in this area will help those suffering from Diabetes and in particular individuals who are unable to properly treat their disease (esp. children). From a business stand-point, a revolutionary product that is intuitive, effective and safe will provide a huge advantage in a market that seems stuck on the stick meter.

 

 

Adult Stem Cells Continue to Show Promise for Diabetes Research and Therapy

Stem cell research is a promising component of what we hope will bring about a cure-like therapy for diabetes.  It may also provide models that enable the unraveling of Type 1 Diabetes and the mechanisms that bring about an auto-immune attack on islet cells.

We understand the ethical problems with destroying and harvesting an immature human in support of embryonic stem cell research. In addition, ESCR carries with it other challenges that have signifantly limited practical success including rejection and the potential for unpredictable growth.

Adult stem cells, derived from the same person they will be used to eventually treat, may enable the growth of insulin-producing cells, which could be used to repair the imcomplete pancreas.  Alok Jha, writing for the Observer, has an excellent piece that details the advantage that reprogrammed adult stem cells have:

Key to this is the discovery, in the past few years, of a way to make stem cells that do not require the destruction of embryos. In one move, these induced pluripotent stem (iPS) cells remove the ethical roadblocks faced by embryonic stem cells and, because they are so much easier to make, give scientists an inexhaustible supply of material, bringing them ever closer to those hoped-for treatments.

(…)

In 2007, Shinya Yamanaka at Kyoto University in Japan demonstrated a way of producing ES-like cells without using eggs. He took a skin cell and, using a virus, inserted four specific bits of DNA into the skin cell’s nucleus. The skin cell incorporated the genetic material and was regressed into an ES-like cell – it had been “reprogrammed” using a batch of chemicals in the lab. In a few short experiments, scientists had a near-limitless supply of stem cells that were, seemingly, as good as ES cells for their research.

As I mentioned earlier, one of the key applications for these cells is the development of models to study disease states:

Models using iPS cells have proliferated in a few short years: they are now available for, among other things, motor neurone disease, juvenile diabetes and sickle cell anaemia.

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The Cure – devices, transplants, stem cells and stopping beta cell attackers

I’m a proud techno-geek.  As a result, when I think about diabetes I tend to gravitate to technology oriented device solutions.  An Artificial Pancreas, a non-invasive blood glucose meter and interchangeable/inter-operable pumps and meters.

And, I like data, lots of data.

While technology is very important, the holy grail of diabetes research is not the future medical device with Star Trek capability unless it is able to promote and bring about a cure.

Pancreas and islet transplants have benefit individuals but have not yet provided a treatment that is worth the risk for most individuals.  And, even if the risks were mitigated, the lack of suitable donors is another impediment.

To me, the ideal is the development of implantable islets from adult stem cells take from the same individual who will receive them.  Rejection of the islets would be minimized and the us of immunosuppressive drugs, I would guess, could be minimize.  In short, Autologous Stem Cell Therapy Transplant requiring no immunosuppression

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Islet Transplantation for Type 1 Diabetes

At one time I believed that islet translation would lead to a therapeutic treatment and cure for Type 1 diabetes. Presentations by noted surgeons and their endocrinologist partners were hopeful and suggested that short-term trials were highly successful.
However, long term observations seem to have revealed two key factors: (1) the effectiveness of the transplanted cells diminishes through time and (2) their are risk factors associated with the immunosuppression drugs.

Consider the summary from a recent British Medical Journal Commentary:

Summary points
Islet of Langerhans transplantation is used in a select group of patients with type 1 diabetes with severe glycaemic lability, recurrent hypoglycaemia, and hypoglycaemia unawareness
The procedure is minimally invasive, with few procedure related complications
Two to three islet infusions are usually needed to achieve insulin independence

Most patients need insulin by five years post-transplantation owing to declining graft function; beneficial effects on the frequency of hypoglycaemic episodes and hypoglycaemia awareness remain

Most long term complications are related to systemic immunosuppression

The risk-benefit ratio of islet transplantation should be carefully weighed by the treating physician and the potential recipient, who should be given adequate information

As I understand it, the target population as those individuals with Type 1 Diabetes who are unable to achieve satisfactory (safe) results with conventional therapy. So, islet transplantation is not (yet) the holy grail many of us had hope but it is never-the-less beneficial for some individuals.

Gastric Bypass Surgery Reverses Heart Ailments!

gastric-bypass-surgery.jpgThis is fairly significant news…. gastric bypass does help lose weight and treat diabetes (more here):

Well- who is a candidate for these procedures? Usually patients with a BMI of over 40 or over 35 with health consequences that are obesity related. Does gastric bypass have any effect on diabetes? In a series of 1000 patients, 150 of whom had diabetes, 83% experienced resolution of their diabetes (defined by a normalization of A1c and coming of medications for diabetes) after the surgery

However, there now appears to be additional benefits:

A new report from the Journal of the American College of Cardiology reports that patients who had received gastric bypass surgery not only lost weight but had maintained healthier cardiac health, while also reducing previous cardiac complications spurred by obesity.

Often times when a patient is obese, an increase in the largest portion of the heart, the left ventricle can become larger in mass causing the heart to work harder to pump blood into the body. According to the study, echocardiograms, or ultrasounds of the heart showed a remodeling of the heart structure which included a reduction of left ventricular mass and right ventricular cavity area in patients that had received Gastric Bypass Surgery, a procedure Texas Bariatric Specialists performs.

“Patients now have another reason to add to their check-off list of the benefits of a gastric bypass. Why would anyone severely obese wait any longer when the health risks are too high,” says Texas Bariatric Specialists founder Dr. Nilesh A Patel.
A gastric bypass is a bariatric procedure that is the single largest contributor to these findings and is offered at Texas Bariatric Specialists. In the Laparoscopic gastric bypass surgery procedure, the surgeon makes a small stomach pouch at the top of the stomach, the pouch is later connected to the small intestine bypassing the larger stomach. The gastric bypass can result in complete resolution in type 2 diabetes, hypertension, high blood pressure, sleep apnea, and the loss of 65 percent of excess body fat.

Source: press release

Promising New Anti-cancer Treatment Approved For HER2-Positive Breast Cancer

The FDA has approved Tykerb (lapatinib), a new targeted anti-cancer treatment that is significantly more effective than current medicines in fighting advanced stage of breast cancer, for use in combination with capectabine (Xeloda), another cancer drug, for patients with advanced, metastatic breast cancer that is HER2 positive (tumors that exhibit HER2 protein): The combination treatment is indicated for women who have received prior therapy with other cancer drugs, including an anthracycline, a taxane, and trastuzumab (Herceptin). According to the American Cancer Society, about 180,000 new cases of breast cancer are diagnosed each year. Approximately 8,000 to 10,000 women die from metastatic HER2 positive breast cancer each year.
more at Hyscience

Online Glucose Stats Soon to be Available

You may have guessed it already but I like online tools. So when the announcement about the launch of SugarStats showed up on digg.com my interest was peaked.
SugarStats is an online service aimed at enabling individuals with diabetes to manage, monitor and share their blood glucose levels. Glucose readings are entered online and stored in a simple interface and can be accessed from anywhere at any time, even via a cell phone or mobile device.
The ultimate goal, of coarse, is improved diabetes management through better control of blood sugar levels.
The concept is really cool and I’ve just requested to be a beta tester. You can do the same (click here – the site offers no guarantees). Having only been recently introduced to the concept, I’m not sure where the project is going but hope the creators of the software have considered adding some type of social networking tools (e.g., facebook.com) to their interface (yes, it’s always easy to ask for more). I think this would likely increase excitement, commitment and use.

Burning Fat Away

No, this is not a solution for exercise and a healthy diet. However, the use of a laser to break down fat in adipose and dermal tissue may well bring a boon to cosmetic surgeons and dermatologists:

Scientists in the U.S. are in the process of developing a laser which melts fat and they believe that in future it could be used to treat heart disease, cellulite, and acne.
A team of researchers at the Wellman Center for Photomedicine at Massachusetts General Hospital, Harvard Medical School and the Department of Energy’s Thomas Jefferson National Accelerator Facility, say the laser is able to heat up fat in the body without harming the overlying skin.
By using a high intensity laser beam they were able for the first time to heat the fat up, which was then broken down and excreted by the body.

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