Innovative Insulin Delivery Patch-Pen About to Hit the Market

January 24th, 2011

In a recent Loyola University study out of Maryland, 60% of diabetics admitted to occasionally skipping doses of their diabetes medication, 20% admitted to regularly skipping their medication, and one-third of respondents admitting to dreading their insulin injections.

Most diabetics who give themselves insulin injections use traditional syringes or the newer insulin pens. Although insulin pens can be used more discreetly than insulin syringes, insulin dependent diabetics often find it inconvenient and/or embarrassing to inject their insulin in public.

A California company, Calibra Medical, has developed a new insulin delivery system designed to save diabetics the "occasional social challenges" of daily mealtime injections. The new device, Finesse, is a small plastic patch-pen roughly 2 inches long and an inch wide that is attached to the skin like a bandage. It can be worn under your clothes, and remains attached during routine activities like sleeping, exercising and even showering.

Patients use a syringe to pre-fill the patch-pen with a three-day supply of insulin, and simply push two buttons to dispense a dose of fast-acting insulin when needed. The insulin is delivered in seconds through a miniature, flexible plastic tube inserted painlessly into the skin. The device can be operated through your clothing for discreet dosing. The device would not replace the need for long-acting insulin injections.

"Most patients want to eliminate the social embarrassment, elaborate preparation before each dose and the many daily needle sticks required by syringes and insulin pens," says Calibra Medical's Charman and CEO, Jeffery Purvin. "Like expensive insulin pumps, Finesse provides fast, discreet, needle free dosing. Yet it accomplishes this with the simplicity, safety and affordability of syringes or insulin pens."

Finesse recently received FDA approval, and should be on the market soon. Calibra is also working on a patch-pen that would deliver a .05 unit insulin dose for children.

Insulin Therapy Changing With New and Improved Insulin Delivery Methods

April 14th, 2011

An old insulin syringe
Not that long ago, being insulin dependent meant you had to carry around a syringe and a vial of insulin to deliver your insulin injections, making sure to keep them refrigerated. There are now a variety of methods for insulin delivery on the market, and some promising new developments on the horizon. These include:

1) Insulin pens. Most types of insulin are now available in convenient prefilled pens. Some insulin pens are entirely disposable when empty, and others use a replaceable insulin cartridge, usually containing 300 units. There is a dial on one end to set your desired dose. The pens offer discreet, push button insulin delivery. Some claim the injections are more comfortable than from a needle that has already been dulled by insertion into an insulin vial. Many people prefer to use an insulin pen if they are caring for a diabetic child or pet.

2) Insulin pumps. Insulin pumps are a device about the size of a pager that adhere to the skin and are worn 24/7. Insulin pumps contain an insulin reservoir, a battery powered pump, and a programmable computer chip that allows the user to control insulin dosing.

The pumps is attached to a thin plastic tube called a cannula, which is inserted just under the skin to deliver insulin subcutaneously and continuously. Insulin pump technology is constantly being improved upon. The newer pumps are smaller, and can "communicate" and interact with a continuous blood glucose monitor and computer software for state of the art blood sugar control.

3) Insulin jet injectors. Insulin jet injectors deliver a fine jet of high pressure insulin directly through the skin. The main advantage is that that the insulin delivery system requires no needles. The major disadvantage is that many diabetics find the force required for the insulin to permeate the skin is painful, and may cause bruising. Jet injectors have been on the market since 1979, but have yet to become popular.

4) Insulin patch. The FDA has just approved a new insulin delivery patch. The new device, Finesse, is a small plastic patch-pen roughly 2 inches long and an inch wide that is attached to the skin like a bandage. It can be worn under your clothes, and remains attached during routine activities like sleeping, exercising and even showering.

Patients use a syringe to pre-fill the patch-pen with a three-day supply of insulin, and simply push two buttons to dispense a dose of fast-acting insulin when needed. The insulin is delivered in seconds through a miniature, flexible plastic tube inserted painlessly into the skin. The manufacturer, Calibra is also working on a patch-pen that would deliver a .05 unit insulin dose for children.

5) Inhaled insulin. The FDA approved the first insulin inhaler, Exubera, in 2006. It was a short-acting insulin delivered to the lungs through a device similar to an asthma inhaler. But it never achieved market success, and was discontinued a year later.

But research on inhaled insulin continued, and two new forms are poised to hit the market. One is an insulin inhaler, AFREZZA, which is awaiting FDA approval. The other is an insulin spray which is absorbed through the mouth, called Oral-Lyn. Oral-Lyn is in Phase 111 clinical trials in Europe and North America.

Despite some obvious advantages to the new insulin delivery methods, tried and true insulin syringes remain the most popular way to deliver insulin injections with most insulin dependent diabetics, who no longer consider injections a big deal.

Insulin pens, insulin pumps, and insulin jet injectors are all more costly than insulin syringes, and not always covered by medical insurance.Not all types of insulin are available in insulin pens, and you can't mix insulin types in a pen.

Insulin pumps can kink or otherwise malfunction, posing the danger of inaccurate insulin dosing, and are just too "high tech" for some diabetics. Many diabetics remain skeptical of devices like insulin inhalers and sprays after Exubera's spectacular lack of success.

Still, with the advances being made in insulin pumps, and the pending introduction of an improved inhaled insulin and the insulin patch, the world of insulin therapy is definitely changing - and most would say for the better.

Do You Need a Diabetes Emergency Survival Kit?

September 1st, 2011

Essential Preparedness Products (EPP) is marketing an emergency survival kit designed specifically for diabetics. The Diabetic med-Ecase is light weight, watertight, airtight, crush resistant, and will float in water.

The survival kit comes complete with glucose tablets, alcohol swabs, a syringe container, an ice pack, a log book to track insulin injections, diabetes medication bottles and a 7-day pill dispenser. Water purification tablets can be purchased as an add-on..

The rugged yellow case has customized compartments for insulin vials, insulin syringes, insulin pens, blood sugar meters, glucagon, and blood and ketone testing stripes. Users fill them with their own personal diabetes medication and supplies.

EPP focuses on emergency preparedness for those with serious medical conditions, creating customized med-Ecases containing necessary medications and supplies in preparation for an emergency, natural disaster, or just travel. Their Diabetic med-Ecase can be ordered online through the EPP website for $69.99.

Overcoming Injection Anxiety

September 20th, 2011

Have you or someone close to you been newly diagnosed as an insulin dependent diabetic? Are you anxious about giving yourself or your dependent insulin injections? Many diabetics say that giving themselves an insulin injection is the hardest part of the condition.

Or perhaps you're an experienced diabetic who hasn't kept up to date on the latest insulin delivery methods like spring loaded syringes, insulin pens and insulin jet injectors. Skipping doses of diabetes medication can lead to poor blood sugar control and diabetes complications. WebMD feature writer Stephanie Watson offers some practical advice in an article titled Overcoming Objections to Injections.

Woman Murders Husband with Massive Insulin Injection

September 29th, 2011

The prosecutor in Alicante, Spain has requested a prison term of 29 years for a woman accused of murdering her husband with a lethal insulin dose.

Fifty-one-year-old Gregoria CS, a Spanish woman on diabetes medication since 1998, was responsible for administering medication to her husband, Juan Antonio GC, diagnosed with HIV.

Gregoria allegedly first dosed her husband with insulin on March 30th, 2007 after a family row, resulting in his admission to hospital in a hypoglycemic crisis. He remained in hospital for a month.

On a second occasion on June 28th, 2010, she injected her sleeping husband in the neck with a massive dose using three insulin pens, and when he woke up smothered his cries for help with a pillow.

The next morning the couple's children raised the alarm when their father would not wake up.He was transferred to hospital in Elche with severe hypoglycemia and was stabilized, but remained in a vegetative state until his death on February 4th, 2011.

The woman had accused her husband of psychological abuse. The prosecutor's requested term of imprisonment comprises 11 years for the first murder attempt and 18 years for the second.

From the online newspaper, RoundTownNews.

Novo Nordisk Files for Approval of Ultra Long Acting Insulin

October 5th, 2011

Insulin

Novo Nordisk today announced the submission to the U.S. Food and Drug Administration of two new drug applications for ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart. These insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes.

"We are very excited about being able to file for the approval of insulin degludec and insulin degludec/insulin aspart now also in the US," said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk. "This is another significant milestone for Novo Nordisk and for the millions of people with diabetes who require insulin injections."

As with the European applications submitted on September 26, the U.S. filings are based on results from the BEGIN and BOOST clinical trial programs, which involved nearly 10,000 type 1 and type 2 diabetes patients. Data from the trials have shown insulin degludec to lower blood glucose levels, while demonstrating a low rate of hypoglycemia, especially at night.

The trials also showed that insulin degludec can be administered once daily at any time of the day with the possibility to change the insulin injection time from day to day according to the needs of the individual patient.

Novo Nordisk intends to make both diabetes medications available in a prefilled insulin delivery device. In the clinical trials, insulin degludec was studied in insulin pens that could either deliver up to 80 units or in a concentrated formulation up to 160 units in a single injection.

Insulin degludec is an ultra-long-acting basal insulin analog discovered and developed by Novo Nordisk. It forms multi-hexamers upon subcutaneous injection, resulting in a soluble depot from which there is a slow, continuous and extended release of insulin degludec. This may contribute to a lowering of blood glucose levels and low rates of hypoglycemia, especially at night.

Insulin degludec/insulin aspart contains the ultra-long-acting basal insulin degludec with a bolus boost of insulin aspart. Insulin degludec/insulin aspart is the first and only soluble insulin co-formulation of ultra-long-acting insulin degludec and insulin aspart providing both fasting and post-prandial control.