Insulin Patch Offers Hope of Needle Free Diabetes Management

Transdermal Specialties Inc. (TSI) is hoping to change the face, not to mention the abdomen, upper arm and thighs, of patients with diabetes.  The company’s new “Set IT And Forget IT” insulin delivery system will be unveiled at the American Diabetes Association’s 72nd Annual Scientific Meeting, June 9 -11, 2012 in Philadelphia.

Called the U-STRIP™, this breakthrough product is a programmable transdermal insulin patch which offers totally non-invasive insulin delivery for both Type-1 and Type-2 diabetic patients.

Using a patented alternating ultrasonic waveform process to enlarge the diameter of the skin pores, the U-Strip enables large molecule drugs, such as insulin, to permeate through the skin into the dermis and then into the blood stream. All without needles!

According to TSI, the key advantages of the U-Strip include:

• Delivers insulin for both basal and bolus needs
• Patches available in four different doses: 25, 50, 100 & 150 Units
• Electronic delivery system tracks dosing history and glucose readings
• Downloads data to physician for progress monitoring

12 clinical trials in over 125 diabetics have already been successfully completed. The company hopes to complete the last two clinical trials needed for FDA approval in the next 18 months.

The HPT- 6 trial will investigate whether the patch can reach the same glucose levels as a pump with less insulin, and will also compare the speed of delivery vs. injection to determine if the patch can be more effective in morning glucose reduction for those patients waking with high blood sugar levels.

The HPT-7 trial (slated for 2013) will focus on a real-world study of 500 Type-2 diabetics, who will conduct an at-home study to track their A1C levels. The A1C test measures average blood glucose control for the past 2 to 3 months.

“The U-Strip represents a major advance in diabetes care” says Bruce K. Redding, Founder, President and CEO of TSI. “The insulin patch component offers a safe and painless alternative to injections with the promise of reduced side effects and improved insulin uptake efficiencies for the patient. The ultrasound actually reduces the quantity of insulin needed for effective glucose control and speeds the delivery over a pump or even direct injection. Improved patient monitoring and reporting of the Control Device enables better tracking of treatment programs and the new “Set-it and Forget-it”  function means more regular glucose control during both evening and daytime hours.

All of which sound like good news for the 27 million diabetics in the US, who eagerly await an alternative to injections. Over the years, various attempts, some more successful than others, have been made to capture this $3 billion market.

SRxA’s Word on Health will be keeping a watch on all diabetes developments and we’ll bring you further news as it happens.

A Diabetics Best Friend

Guide dogs, watch dogs, hearing dogs, mobility assist dogs,  lap dogs, big dogs, small dogs – SRxA’s Word on Health readily admits to a fondness for them all.

So it’s hardly surprising that we were drawn to a story about Early Alert Canines, a non-profit group in California that is training man’s best friend to detect the subtle scents of low blood sugars and matching them with Type 1 diabetics.

These diabetic alert dogs are trained to recognize the biochemical scent that a diabetic’s body gives off as his or her blood glucose begins to change. The dogs learn that this biochemical scent is a command to the dogs for them to carry out an “alert” action – an early warning that can help their human partners avoid acutely dangerous hypoglycemia, and hyperglycemia.

Because hypoglycemia (low blood sugar) can cause severe problems including coma and death, and because hyperglycemia can contribute to long-term diabetes complications, these early warnings, allow diabetics to check their blood glucose levels and treat themselves appropriately. Thus, these amazing dogs are a not only a diabetic’s best friend, they also become life-changers and life-savers.

Although medical technology makes it possible for diabetics to regularly their own blood sugar levels, there are many times when such checks are problematic or even impossible; during sleep or during intense exercise, school work, or business meetings. Early Alert Canines, on the other hand, are always on alert for their insulin-dependent partners, ready to warn them about critical changes in their blood sugar levels.

“We can’t smell it … It gets down to a molecular level,” says organization executive director Carol Edwards, noting the detection of a “cocktail of chemicals,” such as acetone, adrenaline and endorphins, which are released into the bloodstream as a diabetic’s glucose is dropping.

One person benefitting from the program is Nancy Harrison from California. Over a period of 17 years, paramedics have been dispatched on numerous occasions to revive her during hypoglycemic episodes. Instead of being woken by strangers in blue, wielding an IV and bag of dextrose 50%, when her glucose level starts to plummet.
she now finds an 80-pound yellow Labrador on her chest, alerting her the fact.
“He gets in my face … he’ll plow me down to get me to pay attention to him,” says Harrison, about her dog Kade.

Trained initially by Guide Dogs for the Blind, Kade preferred to eat paper towels, socks and dryer sheets making him unsuitable for the sight-impaired. But when it comes to alerting Harrison, he is all business. When he  commutes with her to work he will put his head on her shoulder and start licking her face if her blood sugar starts to drop.

Early Alert Canines (EAC) trains two main classes of diabetic alert dogs: full-access service dogs and skilled companion dogs.

Full Access Service Dogs are trained and placed with diabetic adults and children age 12 and older. These dogs are fully trained diabetic alert dogs and attend work, school, extracurricular activities, errands, etc., with their diabetic partners. These dogs are accredited service dogs and can legally accompany their diabetic partners anywhere the general public is allowed. Full Access Service Dogs are perfect for people who can commit to having a dog with them all hours of the day.

Skilled Companion Alert Dogs are trained and placed with diabetic children, families with multiple diabetics, and some adults who find a service dog won’t fit into their lifestyle. Skilled Companion Alert Dogs are fully trained in hypoglycemic alerting, and do most of their work in the diabetic’s home, but do not have public access rights.

In order to qualify for the program potential dog owners must be insulin-dependent diabetes who have been using insulin for at least one year and diligently manage their diabetes. EAC is keen to point out that their dogs are not for people who are not attempting to closely control their diabetes. The application process involves an online application, paper applications, a phone interview, a home visit and orientation. There is an application fee of $100.

If approved, the diabetic attends Team Training, during which the diabetic may be matched up with a dog that the staff determines to be a good fit for the individual’s needs. Diabetics seeking placement with a skilled companion attend a one-week course, and diabetics seeking full access service dogs attend a two-week course.

For more information about these very special dogs and the Early Alert Canine program click here.

Drugs That Can Land You in the Emergency Room

It’s midnight at the fire station and a call goes out for a patient who has overdosed. In addition to an ambulance and medic unit, police are dispatched.  As we stage for the police, to ensure that the scene is safe, we speculate as to what we’re going to encounter. Will the patient be conscious? What sort of emotional distress has driven them to this? Is it a serious attempt or a cry for help?  Will there be weapons?

As we mentally run through all types of scenarios, it’s doubtful that many of us have considered that our patient will be an 82 year old great grandmother armed with nothing more than her reading glasses and the remote control.

But increasingly that’s what we might find.  As Americans live longer, we have an increasingly frail population suffering from a greater number of chronic conditions, taking more medications than ever before. Among adults 65 years of age or older, 40% take 5 – 9 medications and 18% take 10 or more.

This type of polypharmacy is associated with an increased risk of adverse events. Older adults are nearly seven times as likely as younger persons to have adverse drug events that require hospitalization.

According to a recent article in the New England Journal of Medicine blood thinners and diabetes drugs cause most of the unintentional overdoses that lead to emergency hospitalization in older patients.

Researchers reviewed the records of 100,000 hospitalization events due to major drug side effects in people aged 65 and above from a representative sample of 58 hospitals.  Almost half, (48%) of adverse drug event (ADE)-related hospitalizations occurred in patients older than 80.

The drugs they looked at included prescription and over-the-counter medications, vaccines, and dietary supplements.

Adverse events were categorized as allergic reactions, undesirable pharmacologic or idiosyncratic effects at recommended doses, or unintentional overdoses.  Other effects included problems due to medication-delivery methods (e.g., choking) and vaccine reactions. Visits for intentional self-harm, drug abuse, therapeutic failures, and drug withdrawal were excluded.

Shockingly, just four medications accounted for more than two-thirds of emergency hospitalizations:

• warfarin (a blood thinner to prevent clots) – 33%
• oral antiplatelet agents (for heart attack prevention) – 13.3%
• insulin (for diabetes) – 13.9%
• oral hypoglycemic agents (for diabetes) -10.7%

Given that emergency hospitalizations caused by ADEs result in significant morbidity and enormous costs it’s not surprising that decreasing harm to patients and reducing costs by preventing re hospitalizations is a goal of the $1 billion federal initiative Partnership for Patients.

Achieving a 20% reduction by the end of 2013 may sound ambitious, but in fact there are a number of simple steps that we can take.

1. Make sure that everyone taking medications has an up-to-date list, including all prescribed drugs as well as vitamins, herbs, and OTC medicines. Copies of the list should be kept in their wallet and should be shared with all doctors they see so that the potential for drug interactions can be assessed and avoided.
2. Alert your loved ones that blood thinners and diabetic medicines account for 50% of hospitalizations due to ADEs. Blood thinners and diabetes medications should be regularly monitored by the primary care physician.
3. Encouraging medication compliance can lengthen a person’s lifespan. Too many times patients stop their medications due to a comment made by a well-meaning friend who has  read something on the Internet. Often the doctor is not informed and the patient may not understand the positive effects of the medication or the dangers of stopping them suddenly.

These small measures may not only save the life of your elderly loved-ones, but they may also  reduce your Word on Health bloggers’ middle of the night 911 dispatches.

Found! Fat’s “Master Switch”

Now if only we could find a way to switch it off!

In a breakthrough discovery that has all of us here at Word on Health really excited, scientists have found that a gene that acts as a master switch controlling other genes found in fat tissue.

The study published in Nature Genetics could help to target metabolic diseases such as  obesity, heart disease and diabetes.  More than half a billion people, or one in 10 adults worldwide, are obese. These numbers have doubled since the 1980s as the obesity epidemic has spilled over from wealthy into poorer nations and the trend is expected to continue.

In the United States, obesity-related diseases already account for nearly 10% of medical spending – an estimated $147 billion a year.

Type 2 diabetes, which is often linked to poor diet and lack of exercise, is also reaching epidemic levels worldwide as rates of obesity rise.

The London based research team analyzed more than 20,000 genes in fat samples taken from under the skin of 800 British female twin volunteers. They found the KLF14 gene acts as a master switch to control genes in fat tissues. They confirmed their findings in fat samples from a separate group of people from Iceland.

Genes found to be controlled by KLF14 are linked to a range of metabolic traits, including body mass index, obesity, cholesterol, insulin and glucose levels.

“This is the first major study that shows how small changes in one master regulator gene can cause a cascade of other metabolic effects in other genes,” said lead investigator Tim Spector of King’s College London.

The team are now working hard to see how they can use this information to improve treatment of obesity and obesity-related diseases.

As always we’ll be watching, waiting and writing as soon as we hear more.

Taking the Ouch out of Diabetes

New findings from UT Southwestern Medical Center researchers suggest that Type 1 diabetes could be converted to an asymptomatic, non-insulin-dependent disorder by eliminating the actions of a specific hormone.

Type 1 diabetes affects about 1 million people in the U.S.  In these people, the pancreatic islet cells that produce insulin are destroyed and sufferers must take insulin multiple times a day in order to metabolize blood sugar, regulate blood-sugar levels and prevent diabetic coma. They also must adhere to strict dietary restrictions.

These new studies in mice show that insulin becomes completely superfluous and its absence does not cause diabetes or any other abnormality when the actions of glucagon are suppressed.

Glucagon, a hormone produced by the pancreas, prevents low blood sugar levels in healthy individuals and causes high blood sugar in people with type 1 diabetes.

“We’ve all been brought up to think insulin is the all-powerful hormone without which life is impossible, but that isn’t the case,” said Dr. Roger Unger, professor of internal medicine and senior author of the study appearing online and in the February issue of Diabetes. “If diabetes is defined as restoration of glucose homeostasis to normal, then this treatment can perhaps be considered very close to a cure.”

Insulin has been the gold standard for type 1 diabetes (insulin-dependent diabetes) since its discovery in 1922. But even optimal regulation of type 1 diabetes with insulin cannot restore normal glucose tolerance. These new findings demonstrate that elimination of glucagon restores glucose tolerance to normal.  In other words, if you don’t have glucagon, then you don’t need insulin.

Dr. Young Lee, assistant professor of internal medicine at UT Southwestern and lead author of the study, said the next step is to determine the mechanism behind this result.

““If we can find a way to block the actions of glucagon in humans, then maybe we can minimize the need for insulin therapy.”

Here at Word on Health, we’re sure that for those with diabetes, anything that reduces the need for injections has to be a positive.

Inhaled Insulin as effective as Injected Insulin

Diabetes, affects 26.8 million people in the U.S. It is characterized by the body’s inability to properly regulate  blood sugar levels. Insulin, a hormone produced by the pancreas, normally regulates the body’s glucose levels, but in people with diabetes insufficient levels of insulin are produced or the body fails to respond adequately to the insulin it produces.

Current mealtime insulin therapy has a number of limitations, including the risk of severe hypoglycemia (low blood sugar), weight gain, inadequate post-meal glucose control, the need for complex titration of insulin doses in connection with meals and, of course, the need for injections.

So Word on Health was excited to hear that needles may soon become a thing of the past.  According to the manufacturer, investigational inhaled insulin works at least as well in patients with Type 1 diabetes as standard injection therapy.

MannKind Corporation announced yesterday that a new Phase III clinical trial showed that the ultra fast-acting inhaled insulin AFREZZA (insulin human [rDNA origin]) combined with basal insulin worked at least as well as injectable Humalog (insulin lispro [rDNA origin]).  Additionally, patients receiving the inhaled insulin showed lower rates of hypoglycemia, lower fasting and post-prandial blood glucose levels than those receiving subcutaneous injections

“Effectively controlling blood sugar levels and managing hypoglycemic events go hand in hand as key to successfully treating patients with Type 1 diabetes,” said Satish K. Garg, M.D., Professor, Departments of Pediatrics and Medicine, University of Colorado School of Medicine; Head, Young Adult Diabetes Clinic, Barbara Davis Center for Childhood Diabetes, and lead study investigator.   “Our findings demonstrate that AFREZZA may offer a significant advance from current mealtime insulin delivery methods, as it is comparable to the standard of care in glycemic control and provides the additional benefit of lower hypoglycemia rates.”

AFREZZA^TM is a drug-device combination product, consisting of Inhalation Powder and a small, easy- to-use inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved more than 50 different studies and over 5,000 adult patients with both Type 1 and Type 2 diabetes.

MannKind is currently preparing its FDA resubmission of the AFREZZA new drug application and is hoping to gain approval for the treatment of adults with Type 1 or Type 2 diabetes.