William Petit Joins Company Developing Diabetes Device

Dr. William Petit is a partner in a company that’s developing a new device for testing diabetes.

Petit is one of four principals in Quick LLC, a Farmington-based company that announced Thursday the start of a fundraising campaign to raise money for developing a prototype of the device and testing it.

Petit said he got involved with the company because it’s an opportunity to be involved with something that could solve the long-discussed problem of how to make it easier to measure glucose levels in diabetes patients. He is friends with Scott Fox, the president and CEO of the company.

“Over the course of a number of rounds of golf, he told me about what was going on,” Petit said.

David Mucci and Ron Clark, both doctors at the Hospital of Central Connecticut who developed the device, demonstrated it to Petit.

Instead of using a finger prick to test blood, the device measures glucose levels in saliva. It’s easier and less painful, Petit said, especially for people who need to test themselves several times each day. Some people don’t test themselves as often as they should, Petit said, because of the pain and inconvenience.

“It’s a fascinating idea and I give credit to Dave Mucci and Ron Clark,” he said in a telephone interview. “People have been looking for ways to measure glucose levels for some time.”

The device also connects to smartphones so that parents can track their children’s tests.

A former medical director of the Joslin Diabetes Center at the Hospital of Central Connecticut, Petit hasn’t practiced medicine since 2007, when his wife and two daughters were killed in a brutal attack in their home. Since that ordeal, he has worked for the Petit Family Foundation, which has raised and donated more than $1 million to causes that match the interests of his wife and daughters.

He has also advocated for reforming the state’s death penalty law and has served with the Hartford County Medical Association and the Connecticut State Medical Society.

The new device, called the iQuickIt Saliva Analyzer, has been in development for about 18 months, Fox said. The company hopes to raise $100,000 over the next two months on the crowdsourcing website Indiegogo.com, which allows people to raise money for specific goals with contributions from many people.

Fox, Mucci and Clark are the founders of the company. They brought Petit onto the management team to serve as the diabetes advisor. Among other tasks, he’ll oversee the clinical trials when the device gets to that stage.

In a best-case scenario, Fox said, the device could be on the market in about two years.

Petit made news earlier this month when he confirmed that he was considering running for Congress. Petit said Thursday he was still considering a run for the Republican candidacy in the 5th District, and is weighing the time it requires to other commitments, including the foundation, his work with Quick LLC and the fact that he and his new wife are expecting a baby in six weeks.

UNC-Chapel Hill will test new device aimed at diabetes and obesity

— UNC-Chapel Hill researchers are testing a promising device that fights two of the most common health problems that Americans face – obesity and diabetes.

The EndoBarrier is a thin sleeve made of a plastic-like material that lines part of the upper digestive tract so that food simply passes through that section rather than undergoing full digestion.

A team led by Dr. Laura Young of the UNC Diabetes Care Center is part of a nationwide, 500-patient, 20-site study of the device. It has begun seeking local volunteers to participate.

The EndoBarrier has been approved for use in Europe and various countries elsewhere, including Australia, Chile and Israel. It must undergo a large-scale test here, though, before the U.S. Food and Drug Administration will allow it to be marketed in this country.

Diabetes, which is characterized by problems controlling high glucose levels in the blood and often closely tied to obesity, is a big cause of heart disease, stroke and complications that include loss of eyesight and kidney failure.

In patients elsewhere, the EndoBarrier has substantially reduced patients’ weight and lessened and even reversed the symptoms of Type 2 diabetes, by far the most common type.

The device’s effects are similar to those triggered by gastric bypass surgery. One advantage, though, is that it doesn’t require surgery. Instead, it is put in place via the mouth and throat by a relatively simple procedure involving a flexible instrument .

The procedure usually takes about 15 minutes, Young said. And unlike surgery, it’s easily reversible if it causes problems.

If it is effective, she said, the device could also reduce a patient’s need to use various medications for diabetes.

More than 650,000 people in North Carolina have been diagnosed with diabetes, according to the U.S. Centers for Disease Control and Prevention. Nationwide, the number of new cases has been climbing since 1992 and has nearly tripled since then.

The study is focused on the device’s effect on Type 2 diabetes, Young said, with weight loss a secondary interest.

Once the EndoBarrier is installed, improvements in patients’ diabetes symptoms often come within days, before the gradual weight loss that the device causes even kicks in, according to earlier studies and results with patients in other countries.

The effects on diabetes appear to come by not just blocking the body from digested food but also altering hormonal signals that part of the digestive tract sends to other parts of the body, Young said.

“We think it’s a way to help the body respond to the food that comes through it in a different way,” she said.

In earlier, smaller studies, it was effective helping patients controlling blood glucose levels and effective in reducing weight by often double-digit percentages.

It also caused various problems for some patients, including abdominal pain, bleeding and obstructions by the device.

The EndoBarrier was developed by GI Dynamics, Inc., a 10-year-old company based in Lexington, Mass.

Dr. David Maggs, the chief medical officer for the company, said that both the device and the technique of putting it in place have been improved since the early studies. Those changes have significantly reduced the complications, he said.

Another issue with the device is whether its effects last. The EndoBarrier will remain in study participants only for 12 months, the standard period for use in patients elsewhere in the world.

Researchers will continue to follow patients’ conditions for several weeks after the device is removed, Young said, in hopes of learning more about what happens after it is out.

At this point, more than 1,000 patients have had the device implanted, Maggs said. After it is taken out, there seems to be a “legacy effect” that keeps blood glucose at improved levels and weight down, but there is only limited data so far on that.

If the trial proves that the device works and is safe, it is expected to be widely available by 2017.

Price: 919-829-4526

UPDATE 1-Roche decides against selling diabetes device unit -sources

Thu Sep 19, 2013 10:46am EDT

By Soyoung Kim and Jessica Toonkel

NEW YORK, Sept 19 (Reuters) – Swiss drugmaker Roche Holding
AG has decided against trying to sell its blood glucose
meter business, according to two people familiar with the

At least one other large drugmaker, Bayer AG,
also scrapped plans to sell a diabetes device unit this year.

In the past few months, Roche was looking to sell the
business as the industry faced increased competition and lower
reimbursement rates from U.S. government healthcare programs,
people familiar with the matter told Reuters in May.

However, the reimbursement pressure on diabetes test
supplies lessened the chances of a competitive sales process,
leaving Roche little choice but to hold on to the business,
according to one of the people who spoke to Reuters this week.

The people wished to remain anonymous because they are not
permitted to speak to the media.

A Roche spokesperson said in an email that the company
remains committed to its Diabetes Care division.

Bayer, Germany’s biggest drugmaker, had attempted to sell
its blood glucose meter business for about $1.5 billion, only to
pull the plug on the sale early this year after failing to
attract sufficient interest.

The diabetes device market came under pressure earlier this
year after the U.S. Centers for Medicare Medicaid Services
moved to cut the reimbursement for diabetes test supplies by up
to 72 percent.

The change, which took effect in July, makes it more
difficult for companies to be profitable in this business.

'Reverse vaccine' for Type 1 diabetes seems to pass human test

The therapy is designed to protect cells in the pancreas that make insulin, a hormone the body needs to convert sugars and starches into energy. In people with Type 1 diabetes, the immune system goes haywire and attacks those crucial insulin-producing cells for reasons that medical researchers don’t understand.

Researchers dubbed the treatment a reverse vaccine because it suppresses the immune system instead of stimulating it. As hoped, the experimental vaccine reduced the number of immune system “killer” cells that went on the attack.

“We’re trying to turn off one specific immune response,” said Dr. Lawrence Steinman, an immunologist at Stanford University and senior author of the study published Wednesday in Science Translational Medicine.

About 1.25 million Americans have Type 1 diabetes. For nearly 100 years, the standard treatment has been insulin replacement therapy, in which insulin is injected in amounts that correspond with blood-sugar levels.

Attempts at new treatments and cures have focused on suppressing large portions of the immune system — sometimes using powerful drugs developed for other conditions, such as the blood cancer lymphoma. Steinman called this the “big hammer” approach.

“We’re trying to do something different,” he said. “We want to eliminate just the immune cells that attack the insulin-producing cells in the pancreas.”

Steinman and his team designed a molecule that contained the gene for making proinsulin, the precursor to insulin. The molecule also included instructions for triggering the killer cells’ response and then shutting it down.

If everything went as planned, the DNA molecule would suppress the killer cells and allow the pancreatic cells to function properly, producing insulin.

After successful trials with diabetic mice, the team prepared to test its vaccine on humans. They selected 80 volunteers ages 18 to 40 who had been diagnosed with Type 1 diabetes within the last five years. After that time, many Type 1 sufferers have already lost all of their insulin-producing cells, Steinman said. (Although many people with Type 1 diabetes are diagnosed as children, the researchers avoided testing their reverse vaccine on kids because of safety concerns.)

Two-thirds of the study volunteers received the reverse vaccine in one of four doses ranging from 0.3 to 6.0 milligrams. The rest of the volunteers got a placebo. Injections were made once a week for 12 weeks.

Throughout the study, both the experimental and placebo groups also received insulin replacement therapy. All subjects were monitored for up to two years after the initial treatment to watch for any side effects.

To see whether the vaccine was working, the team measured two key components of the volunteers’ blood: killer cells and C-peptide, a protein involved with making insulin.

Compared with patients who got the placebo, those who received the vaccine in 1.0 and 3.0 mg doses saw beneficial improvements in their levels of C-peptide during and after treatment. But three months after the treatment stopped, C-peptide levels declined, indicating the vaccine had worn off, the team wrote.

Patients in the vaccine group, no matter the dosage, saw the number of killer cells fall and the amount of proinsulin rise over 15 weeks without affecting the rest of their immune system cells. The changes were much more modest in patients who got the placebo.

No significant side effects or safety concerns arose during the study, the team reported.

Dr. Hertzel Gerstein, an endocrinologist at McMaster University in Ontario who treats Type 1 diabetes patients, called the research encouraging, and said he was looking forward to further studies with many more patients.

“It’s a small study with preliminary findings,” he said. “It could or could not translate into anything clinically relevant. But certainly this holds some promise.”

Dr. Peter Butler, director of the Larry L. Hillblom Islet Research Center at UCLA, said a reverse vaccine was a promising approach, but he was concerned that the benefits lasted only a few weeks. It might be impractical to keep the killer cells at bay with such a narrowly targeted vaccine, he said.

Steinman said his team was planning further tests with longer treatment periods.

“This is only a first step,” he said. “But there is potential for protecting people from the ravages of this disease in the long run.”

The study was funded by Bayhill Therapeutics, a start-up founded by Steinman and three of the study’s co-authors. The company, now known as Tolerion Inc., aims to bring the vaccine to market.


USPSTF Favors Gestational Diabetes Testing

All asymptomatic pregnant women should be screened for gestational diabetes after 24 weeks’ gestation, according to draft guidelines from the U.S. Preventive Services Task Force (USPSTF).

The common practice of screening before 24 weeks based on risk factors didn’t get either a thumbs up or down, as the group cited insufficient evidence from its literature reviews appearing online in the Annals of Internal Medicine. The same was true for which test and threshold to use for screening.

The task force had previously suggested insufficient evidence for any gestational diabetes screening.

The update aligns most closely with guidelines from the American Diabetes Association, which recommends screening all women without a preexisting diabetes diagnosis at 24- to 28-weeks’ gestation using a 75-g, 2-hour oral glucose tolerance test (OGTT).

The American College of Obstetricians and Gynecologists recommends screening all but low-risk women, although that organization is also in the process of a guideline revision.

The shift for the USPSTF appeared to have hinged on more evidence for a benefit of treating gestational diabetes since the last revision in 2008.

The literature review by Lois Donovan, MD, of the University of Calgary, Alberta, and colleagues indicated that diet modification, glucose monitoring, and insulin when needed resulted in less preeclampsia, shoulder dystocia, and macrosomia.

“When these outcomes are considered collectively, there is a moderate net benefit for both mother and infant,” the draft guideline noted.

Evidence for long-term metabolic benefits for the mother and baby weren’t certain.

But there was little evidence for harm aside from more prenatal visits. Small-for-gestational age and neonatal hypoglycemia weren’t more common with treatment, although the trials may have been underpowered to detect meaningful differences, Donovan’s group cautioned.

The treatment literature review included five randomized, controlled trials and six cohort studies. The group’s review of the literature on screening turned up 51 studies, but that evidence didn’t show a clear winner among the various strategies.

The characteristics of an oral glucose challenge test with a threshold of 7.8 mmol/L (140 mg/dL) to indicate a positive screen were sensitivity of 70% to 88%, specificity of 69% to 89%, a positive likelihood ratio of 2.6 to 6.5, and a negative likelihood ratio of 0.16 to 0.33, the review found.

A lower threshold of 7.2 mmol/L (130 mg/dL) had higher sensitivity of 88% to 99% but lower specificity of 66% to 77%, which yielded a positive likelihood ratio of 2.7 to 4.2 and negative likelihood ratio of 0.02 to 0.14.

Fasting plasma glucose has been suggested as an alternative initial measurement that is easier and less time-consuming to obtain.

A threshold of 4.7 mmol/L (85 mg/dL) on that test had similar sensitivity of 87% but low specificity of 52% and low positive likelihood ratio of 1.8, which “suggests that it is not as good at predicting an abnormal OGTT result,” the authors noted.

Glycated hemoglobin level has also been suggested as an alternative but had poorer test characteristics than the other tests.

The limited evidence on these alternative screening approaches was inadequate, according to the draft guidelines. It didn’t recommend one screening test or threshold as the best for clinical practice.

There were few data on screening tests before 24 weeks’ gestation.

The period for public comment on the draft guidelines ends June 24, after which the final recommendations will be released.

The reviews were funded by the Agency for Healthcare Research and Quality.

Donovan reported a contract with the University of Alberta Evidence Practice Centre for an evidence report on screening and diagnosis of gestational diabetes, and grant funds from International Diabetes Federation and Eli Lilly.

Primary source: Annals of Internal Medicine
Source reference:
Donovan L, et al “Screening tests for gestational diabetes: A systematic review for the U.S. Preventive Services Task Force” Ann Intern Med 2013; 159.

Additional source: Annals of Internal Medicine
Source reference:
Hartling L, et al “Benefits and harms of treating gestational diabetes mellitus: A systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research” Ann Intern Med 2013;159.

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Crystal Phend

Staff Writer

Crystal Phend joined MedPage Today in 2006 after roaming conference halls for publications including The Medical Post, Oncology Times, Doctor’s Guide, and the journal IDrugs. When not covering medical meetings, she writes from Silicon Valley, just south of the San Francisco fog.

Diabetes screening tests made easier

Canadian doctors have another option when screening people for Type 2 diabetes.

On Monday, the Canadian Diabetes Association unveiled its 2013 Clinical Practice Guidelines to prevent and manage diabetes. It’s estimated a third of Canadians will have either diabetes or prediabetes by 2020.

People age 40 and older should check for diabetes, says Dr. Alice Chen of the Canadian Diabetes Association. (CBC)

The group hopes that a new standardized blood test, called the A1C, will encourage everyone over the age of 50 to get screened once every three years. The single measurement considers average blood glucoses levels over about three months.

The A1C does not require people to stop eating for 12 hours before taking the test as was the case previously. The test can also diagnose prediabetes before full-blown diabetes occurs.

“Pre-diabetes I like to think of as the waiting room to diabetes,” said guideline chair and Toronto endocrinologist Dr. Alice Chen. “We want to be able to identify who is sitting in that waiting and get them out of there as much as we can.”

Through lifestyle interventions such as diet changes, exercise, losing weight, quitting smoking and self management of blood glucose levels, the group aims to prevent people with prediabetes from worsening. In some cases, blood sugar- and cholesterol-lowering drugs will also be prescribed.

Overall, the group’s message for health care professionals was to screen wisely and diagnose precisely since doctors can’t treat what they don’t know.

However, British epidemiologists have questioned whether screening more people saves more lives.

When Dr. Simon Griffin of the Addenbrooke Hospital in Cambridge compared mortality over 10 years in the United Kingdom, he found screening for Type 2 was not associated with a reduction in deaths from all causes, cardiovascular or diabetes.

“The benefits of screening might be smaller than expected and restricted to individuals with detectable disease,” Griffin concluded in the October edition of the medical journal The Lancet.

Screening those with risk factors makes more sense than testing everyone over the age of 40, he said in an interview, adding that since diabetes tests have few risks there is little harm beyond questions of the best use of public health dollars.

“The problem of course with this prediabetes label is it actually labels people and has them living with a lifelong concern about their diabetes when in fact they might have perfectly normal blood sugar levels, they may be otherwise perfectly healthy people,” agreed drug policy research Alan Cassels of the University of Victoria.

The ultimate goal of the guidelines is to avoid serious complications from diabetes such as kidney disease, heart attacks and strokes.

The guidelines were published in the Canadian Journal of Diabetes and on the Canadian Diabetes Association’s website with interactive tools and resources for health care providers and people living with diabetes.

With files from CBC’s Kelly Crowe

Lindsay Lohan fails drug test

Lindsay Lohan has failed her most recent drug test, and claims she is “ready to face the consequences”. In a series of messages on her Twitter account, Lindsay wrote:

“Regrettably, I did in fact fail my most recent drug test.

“Substance abuse is a disease, which unfortunately doesn’t go away over night. I am working hard to overcome it and am taking positive steps forward every day. I am testing every single day and doing what I must do to prevent any mishaps in the future.

“This was certainly a setback for me but I am taking responsibility for my actions and I’m prepared to face the consequences.

“I am so thankful for the support of my fans, loved ones and immediate family, who understand that i am trying hard, but also that I am a work in progress, just as anyone else. I am keeping my faith, and I am hopeful….Thank you all!!!”

Lindsay has only just been released from her sentence that saw her spend nearly two weeks in a prison and just over three weeks in rehab following violations she committed in regards to a 2007 DUI case.

She is currently receiving intense outpatient treatment after leaving the facility two months earlier than was initially ordered. A part of her outpatient program includes two random drug tests every week until her next hearing in November.

The new judge in the case had warned Lindsay that failed drug tests would immediately see her land back in jail for another 30 days. Lindsay said she is ready to face Judge Fox: “If I am asked, I am prepared to appear before judge Fox next week as a result,” she tweeted.

Read our complete coverage on Lindsay Lohan, including Lindsay’s release from rehab, Lindsay turning herself in for prison, what addictions Lindsay has, and whether Lindsay battled an eating disorder.

Images: PR Photos