Medical Device Daily

As a busy college student, 20-year-old Reuben Bresler from Columbus, Ohio, says he has other things to think about than how much insulin he took at his last meal.

Fortunately Bresler, a type 1 diabetes patient, doesn't have as much to worry about if he forgets whether or not he took his insulin or how much he took. He was the first diabetes patient in the U.S. to receive a HumaPen Memoir —a high-tech insulin pen capable of "remembering" his last 16 insulin doses — from Eli Lilly (Indianapolis).

Lilly reported the commercial roll out of its HumaPen Memoir — which it is calling the "first insulin pen with memory" — late last week.

Not only does the new reusable insulin pen help Bresler with the daily management of his diabetes, he said he also appreciates the sleek design that makes the device look much more like a standard writing pen than a medical instrument, but with a small viewing window at one end providing a digital display of the time, date and amount of his last insulin dose.

"It's more inconspicuous-looking. I'm getting way less questions now about 'what are you doing to yourself?' and that sort of thing," Bresler told Medical Device Daily.

The HumaPen Memoir can inject from one to 60 doses of Humalog from a small cartridge. Humalog is the company's flagship insulin, introduced by Lilly as the world's first insulin analog. Humalog can be taken within 15 minutes before or immediately after a meal, enabling patients to adjust the dose according to when they eat, what they eat and how much they eat, Lilly said.

The company demonstrated the HumaPen Memoir at the annual meeting of the American Diabetes Association (Alexandria, Virginia) in Washington in June (Medical Device Daily, June 12, 2006).

Scott MacGregor, a spokesman for Lilly, told MDD that when the company launched its Humalog in 1996 it was considered quite an advantage over its previous insulin because it allowed patients to take their dose at mealtimes instead of having to take it up to an hour before eating.

That's when Lilly began to focus on what it could do to improve the delivery of the insulin for its customers. Through market research, MacGregor said the company learned that patients wanted an insulin pen that was more convenient to use and more discreet to use in public. They also learned that patients were interested in a device that would help them remember when they took their last dose and how much they took.

In a clinical study of experienced insulin pen users, Lilly said 81% of patients preferred Memoir to the pen they were using before joining the study. Memoir was considered easier and more convenient to use than the pre-study pen and rated higher for certain pen features and most tasks related to dosing, the company said. The pen was developed in partnership with Battelle Medical Device Solutions (Columbus, Ohio), where Bresler's dad is the chief scientific officer — which is how he came to be the first U.S. patient to use the new insulin pen.

"Battelle actually helped us figure out how to make the chip wrap around so we could put it into a pen device," MacGregor said.

The cost of the pen is listed as $100 but MacGregor noted that patients would receive it at the company's coupon cost of $45. He also said the pen is designed to last for three years.

Of the 21 million people with diabetes in the U.S., more than four million use insulin to help manage their blood sugar.

"I see real advantages in a new tool such as Memoir that remembers recent insulin doses, including the priming doses. The daily routine of balancing meals and blood sugar readings with multiple insulin injections can be cumbersome and overwhelming for patients," said Linda Siminerio, PhD, assistant professor of medicine and executive director of the University of Pittsburgh Diabetes Institute (Pittsburgh) and senior VP of the International Diabetes Federation (Brussels, Belgium). "Anything that helps simplify the management of this disease and puts patients in a better position to self-manage is beneficial."

Lilly sponsored a national, 1,000-person telephone survey of people with diabetes who inject insulin at least once a day. The survey, conducted by Kelton Research (Los Angeles) in January, showed that respondents were interested in new tools that could help them better manage their disease. One-third of patients surveyed reported that they forgot whether they took their insulin dose at least once a month and 84% said a memory feature would be valuable. The survey also found that looks matter too, with 58% saying they would be interested in using an insulin delivery device that looked like a writing pen instead of a medical instrument.

"Individuals with diabetes face unique challenges in managing this highly complex and personal disease. Practical and innovative solutions such as Lilly's new Memoir pen can help ease the management of diabetes at mealtimes," said Matt Beebe, Humalog brand team leader for Lilly USA. "Our goal is to help patients more accurately and discreetly manage their use of mealtime insulin such as Humalog."

In addition to the HumaPen Memoir, Lilly plans to launch a similar insulin pen in April that delivers Humalog in smaller increments, the HumaPen Luxura HD. The Luxura HD is a reusable pen that can deliver up to 30 units of Humalog in half-unit increments, beginning after the first unit, Lilly said. The company noted that this type of pen might be an attractive option for people with diabetes who do not need large amounts of insulin or for children.