Appendix 2: The History Of Insulin Pumps

Treatment of insulin dependent diabetes involves the use of insulin therapy and providing insulin doses throughout the day. Today, there is an alternative to injecting insulin several times per day in accordance to basal/bolus control. The insulin pump is ideal for those diabetics who are very busy with their lives or for those whose blood sugar levels are very high and cannot be controlled by taking multiple insulin shots per day. The pump provides a way of maintaining better control over blood glucose levels, thereby preventing or minimizing the onset of long-term complications associated with diabetes.

The following series of pictures and discussions reveals the history of insulin pumps.

The first insulin pump was developed in 1963 by Dr. Arnold Kadish. It delivered both glucagon and insulin.

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Dean Kamen is best known for inventing the Segway scooter. Another of Dean’s inventions is the all-terrain Electric Wheelchair known as the iBot. Dean has also invented for swat teams and emergency workers an compressed air powered device that can launch them into the air so that they could reach the top of tall buildings. Dean is alive and well and still inventing. His current project in the works is the inventing of a Water Purification System.

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Dean Kamen invented the first wearable infusion pump, which rapidly gained acceptance from such medical specialties as chemotherapy, neonatology and endocrinology. In 1976 he founded his first medical device company, AutoSyringe, Inc., to manufacture and market the pumps. At age 30, he sold that company to Baxter International Corporation. By then, he had added a number of other infusion devices, including the first insulin pump for diabetics

The Auto Syringe AS2C pump (1977)

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The continuous delivery of insulin could be successfully used in treating Type 1 diabetes. The insulin infusion was given subcutaneously (beneath the skin’s surface). Previously, scientists had tried to improve the principle of the pump (continuous small quantities of insulin) by giving high doses of insulin directly into the veins. This was stopped since these infusions caused great problems due to injection pricks and the danger of sepsis (bacterial infections) and thrombosis (blood clotting). In 1976, a team started to develop a continuous subcutaneous insulin infusion (CSII), a treatment now known as insulin pump therapy. As a basis for this therapy the new development of a battery operated syringe named the “Mill Hill Infusor” allowed continuously released insulin. By turning some screws larger quantities of insulin, now known as “bolus units”, could be transported by the pump. Since the delivering speed of the “basal rate” first was always constant, it had to be adapted with the help of saline solutions. The cannula of the catheter was subcutaneous and fixed with a plaster, while the pump was fastened with a bandage or a net. The replacement of the catheter, however, always required medical interventions that had to be realized under very sterile conditions. This treatment may seem complex but its success justified the further development of the therapy. In Germany, it was the scientists Renner and Hepp who devoted themselves to this kind of work.

The Mill Hill Infuser or Auto Syringe 6C (1980)

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A composite of insulin pumps 1979-1987.

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This is the BioStar glucose controlled insulin infusion system used in the 1980′s. It functioned as an artificial pancreas.

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BD Model 1000

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AS2C (1977) and Minimed 507c (1998)

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In the 1980′s, there were a lot of important developments based on the earlier pump models. At the beginning of the decade, the Auto-Syringe AS6C pump with a variable delivering speed was developed in the United States. With the development of the Promedeus pumps, Siemens was one of the first companies to create implantable pumps. Besides, the so called roller pump was introduced. The CPI 9100, launched in 1982, was one of the first insulin pumps with an individually programmable basal rate. Unfortunately it had to be adjusted every evening as there was no data memory included yet. During the 1980′s, more and more insulin pumps were coming out, introducing some of today’s features, for example the Nordisk Infuser. The Dahedi RW 90/91, a pump that was launched in Holland in the middle of the 1980′s, was the first small and user-friendly insulin pump and it was mainly women who selected this model. The fault of the CPI 9100 mentioned above was eventually resolved by the Hoechst MRS1-Infusor pump. The hourly basal rate could be programmed, although the setting had to be done by a doctor. For the same pump model the first pump insulin was also developed and named H-Tronin. With the addition of surface active substances, it had a more stable flow. The further development of the pump insulin led to the creation of modern day pump insulins like Lilly’s Humalog insulin which I have used for almost 15 years.

The H-Tronin fast acting insulin was used in an experiment on young children in Germany. Since especially young children with dawn phenomenon would benefit from continuous insulin application, night-time only insulin pump therapy was used on four children aged 4-11 years. These patients were monitored in regard to control and satisfaction with therapy. There was no ketoacidosis or technical defects and the rate of severe hypoglycemia rose slightly from 0.0 to 0.063 per patient for each year. Three of the four families reported high satisfaction with the new therapy and an increase in quality of life. The average HbA1c fell from 7.2% to 6.6%. It was concluded that night time only insulin pump therapy might be a safe way of controlling dawn phenomenon in young children with Type 1 diabetes.

Lily (CPI) was one of the first manufacturers to make an advanced pump. This was an insulin pump that used U-100 insulin and had four programmable basal rates. In addition, its size was much smaller than the first generation of insulin pumps and it had a numeric touch keyboard exactly like a microwave oven. It was considered to be the number one pump at that time.

C.P.I. Lily 9100 (1982) & Nordisk insulin pumps

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C.P.I. Betatron II (1983)

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Newspaper ad.

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AS6CMP and Minimed 507c

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In 1984 the Hoechst MRS1 insulin pump was launched. Unlike the earlier rather experimental insulin pump therapy, the possibility now existed of a much more advanced insulin pump therapy. The MRS1 permitted an hourly background rate to be programmed for the first time. Numerous alarm systems provided the necessary security. With the development of H-Tronin 100 two years later, insulin became available specifically for pumps.

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The number of people using pumps increased and the number of pump companies increased but there were disappointments along with the benefits to pump use. Batteries had to be changed every few days with most pumps. Some pumps required very expensive insulin resevoirs. The stability of the insulin was affected by internal mechanisms in some pumps. All pumps delivered insulin under the skin, like a regular insulin injection. A needle had to be kept in the site at all times. This frequently led to infection and soreness, especially for people who were thin. The needle had to be changed every three days to prevent irritation and infection and this is still true with today’s newer and more comfortable needles. It was also discovered that pump users were more prone to DKA due to the fact that there were only a few minutes of insulin in the body at any given moment and a rapid rise in blood glucose would occur when the insulin delivery was interrupted. Many pump users gained 15-20 pounds while pumping.

Pumps were popular for about 5 years but then the use of insulin pumps declined. This was due not only to the previously mentioned reasons but also to the fact that pumping did not give better control than multiple daily injections. Pumps were expensive and damage and breakdowns in the pumps frequently occurred. Many younger pump users didn’t want to wear a pump and be “different” from their nondiabetic friends. Some pump companies discontinued making pumps and their pump users had difficulty in finding pump supplies. By the late 1980′s, there were only a few pump companies left.

An implantable pump was created in the 1980′s but there were difficulties. The implantable pump was placed just under the skin and it was clearly visible. There was a projection from the surgery site much like having a hockey puck placed under the skin. The pump could be implanted in the abdomen or on the chest of the pump user. This pump was refilled with a large-gauge needle and the user carried a programming unit and held the unit over the pump to deliver instructions for refilling the pump. Patients could self-administer a bolus dose with a remote-control device. These pumps are still used on an experimental basis in the United States but are available overseas. Less hypoglycemia has been seen with implantable pumps but blockages of the catheter and infection at the implantation site have occurred.

It is hoped that the technology of implantable insulin pumps will eventually progress to the level of an artificial pancreas. They would deliver insulin and monitor glucose to determine how much insulin is needed at a given moment.

Despite all these drawbacks, two pump companies continued to create innovations in pump therapy. These two companies were MiniMed of California and Disetronic Medical Systems of Switzerland, with a United States office in Minnesota.

Alfred Mann

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In 1979 Alfred E. Mann, then the CEO of Pacesetter Systems, was showing a new pacemaker design at the University of Alabama. The chief cardiologist explained the severity of heart problems due to diabetes and suggested that Al research the possibility of an insulin pump. This moment started Al’s interest in creating an insulin pump to improve the lives of diabetes patients.

In the years that followed the MiniMed 502 and 502A insulin pumps were introduced and the 502A became very popular. MiniMed Technologies Limited was born. In the years that followed the company made further advancements and the newer pumps had menu driven programming, unlimited basal rates, a duel wave bolus and increased memory.

In 2003 Medtronic Diabetes introduced the Minimed 512 and 712 pumps and the world’s first insulin pump and glucose monitoring system. The wireless system used a blood glucose monitor, co-developed with BD (Becton, Dickinson and Company)that could automatically transmit a glucose value to the MiniMed 512 or 712 insulin pumps. The insulin pump’s calculator recommended proper insulin dosages to patients and kept track of insulin used by the body.

Today’s pumps are smaller, more easily operated and offer a much wider variety of features. They are often mistaken for beepers and come in a variety of colors. They are more durable than the pumps of the past and they frequently go unnoticed when being worn.

Modern pumps contain a small syringe and they are connected to the wearer via a small needle (cannula). Battery changes are necessary every few months. These pumps are not yet self-adjusting but they are presently the closest thing to a human pancreas we can get. The newer pumps contain a variety of alarms, which warn the user of clogged tubing and the need for changing the battery. They store huge quantities of data such as when and how much insulin the user has taken or needs to take and when alarms have gone off and for what reason. Lighted screens make it easy to operate the pump in darker locations.

People who use pumps today really want the pump for its flexibility and tight control, and usually test their blood glucose quite often. People who pump are able to run, hike, do workout exercises and even swim while wearing their pumps. Water-tight cases are necessary for swimming. Many professionals, such as 1999’s Miss America, have worn pumps without anyone ever knowing. The pump never holds the user back! At night, I wear my pump on the waistband of my pajamas. The tubing on pumps varies from 24 to 42 inches and so some pump wearers place the pump next to them when they sleep.

In the future pumps are heading toward self-adjustment, toward being a closed-loop system. Such a pump would test the wearer’s blood glucose and deliver an insulin dose as needed.

Currently, there is a blood glucose sensor, worn at the belt like a pump, which measures the blood sugar at specific short-time intervals, through a catheter, like the pump, It gives an averaged readout every few minutes. Eventually, I am sure, this sensor will be incorporated into a pump, making it self-adjusting. Designs are in the works at this very moment, and the technology is here. Within a few years such a device should be available to all those who want to become pump users.

I have used a Mimimed 522 insulin pump since June 19, 2007. The diagram shows a pumper with this pump model clipped to his belt. I wear mine the same way at night but I use a nylon case with a belt loop on the back that completely hides the pump during the day. In public the pump cannot be seen.

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The Evolution of Insulin Pumps

http://nfb.org/legacy/vod/vsum0001.htm

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dLife’s history of diabetes:

http://www.dlife.com/dLife/do/ShowConte … earch.y=10

Other references for Appendix 2.

http://www.phlex.org/Diabetes/informati … pump2.html

http://www.picturetrail.com/sfx/album/view/201986

http://www.minimed.com/about/history.html

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