One of its basic problems "is the potential alteration of the administered insulin by motion, contact with pump surfaces and changes in temperature. Insulin forms aggregated macromolecules that have reduced insulin activity and tend to precipitate in the catheter, causing obstruction. Insulin must be buffered and treated with additives to increase viscosity, thereby improving it physical stability (http://medind.nic.in/ibi/t02/i6/ibit02i6p379.pdf). The pump has another problem, especially prevalent in the initial models, which is "encapsulation by the dense fibrous tissue of the implant. Early versions were plagued by problems with fluid leakage into the system, short battery life, insulin blockage of the pump or catheter and tissue blockage of the peritoneal catheters and adhesions (http://medind.nic.in/ibi/t02/i6/ibit02i6p379.pdf)."

Risks Involved With Insulin Pumps

While insulin pumps have proven to be beneficial, there are risks involved in this form of therapy. Due to the fact "insulin pumps use the very fast-acting Lispro insulin which only lasts three to four hours after injection, Diabetic ketoacidosis (DKA), a life-threatening condition caused by lack of insulin, becomes a real possibility if the pump stops delivering the required amount of insulin. DKA could happen if the pump tubing becomes blocked or comes out from under the skin, or if the pump cartridge is allowed to run out of insulin. If the problem isn't discovered for several hours, blood sugars will rapidly rise and ketones will appear in the urine (http://www.diabetes.ca/Section_Membership/DialogueWin00-insulinpump.asp)." An individual can prevent this condition, however, by frequently monitoring their blood glucose throughout the day.

Another risk involved with insulin pumps is skin infections, which can become a serious condition in a diabetic. An infection can occur at the catheter's insertion site since the "pump catheter or tubing stays in place under the skin. This can be prevented in most people by using good technique when changing the catheter, taking care to keep the site clean, and changing the catheter frequently (usually every two to three days) (http://www.diabetes.ca/Section_Membership/DialogueWin00-insulinpump.asp)."

Pump Users

When the pumps were initially introduced, users had to undergo "psychological testing, stay at least one week in a hospital, and be dedicated to monitoring their blood glucose (http://www.nfb.org/vod/vsum0001.htm)."

Today's users find they are unrestricted in what activities they can participate in, due to innovations such as watertight cases for swimming.

Insulin pumps are so light and small that users are able to wear them without the knowledge of others.

Choosing to use the insulin pump is a personal decision and should be fully discussed with one's healthcare provider. After discussing the use and care of the insulin pump, as well as the benefits and risks involved, the patient should then be able to make a truly informed decision.

Research Data clinical trial provided evidence that "insulin pumps are one of the best methods for near-normal insulin delivery. Approximately half of the adults and a quarter of the teens used insulin pumps at some time during the trial, which resulted in patients intensively managed experienced a lowering of glycated hemoglobin levels and a reduction in long-term diabetes complications when compared to those treated with conventional protocols (http://medind.nic.in/ibi/t02/i6/ibit02i6p379.pdf)."

Insulin Pumps and Children

Insulin pumps have proven to be beneficial to diabetic children of all ages and their parents. Parents of preschool children "report less anxiety about their kids who use the devices compared with families dealing with insulin injections.

While control was equally adequate for kids using continuous infusion and for those using injections, those receiving the injections produced significantly more for their parents. A trend towards less parental anxiety was evident for pump users (http://www.medicalpost.com/mpcontent/article.jsp;jsessionid=ABIDHKOKILJF?content=20040607_194326_5696)."

Insulin pumps have been used in children as young as 5 weeks old. While the pumps are effective in controlling blood glucose levels, the concentration of insulin makes it necessary for a health care professional to monitor its dosage frequently (http://www.insulin-pumpers.org/pkids/youngest.shtml).

The daily injections that diabetic toddlers must endure can be practically be eliminated by using the insulin pump. Another benefit is better dosing, since the "small amounts of insulin needed to maintain glucose in the ideal range make the dosage delivered by a pen or syringe too imprecise (http://www.insulin-pumpers.org/faq/askexpert01.shtml)."

While it was initially thought that newly diagnosed diabetics could not deal with the changes in their lifestyles and the pump at the same time, new research is proving this to be false. A study with pediatric patients has found that "all the newly diagnosed patients and families readily learned the pump mechanics, having no more difficulty than patients who had type 1 diabetes for longer periods; all patients achieved excellent metabolic control without significant hypoglycemia, with blood glucose levels in the near-normal range through the first six months; all patients expressed satisfaction with pump therapy (http://www.insulin-pumpers.org/links.shtml)."

Today's Pumps

Today, for type 1 diabetes, "insulin pump therapy remains the optimal approach with the most flexibility, especially with the ultra-fast-acting analogs lispro and aspart (http://www.medscape.com/viewarticle/488996)."

These brands are "Disetronic Medical Systems, MiniMed Technologies, and Animas (http://medind.nic.in/ibi/t02/i6/ibit02i6p379.pdf)."
The pumps used today are "smaller, easier and safer to use, and more durable than their predecessors. Current models have electronic memory, multiple basal rates, several bolus options, a safety lockout feature, and a remote control, while modern infusion sets have soft cannulas and quick-release options. The historical evolution of external pumps has made CSII a safe and viable alternative to MDI (http://www.postgradmed.com/issues/2002/05_02/bode3.htm)."

Pumps in use today rely on batteries which are easily accessible and last longer than those used in older models. They are able to dispense almost all types of insulin and have alarms "which warn the user of clogged tubing and low power supplies. The newer pumps are able to store important data concerning administration and alarms, have lighted screens (for sighted users in dark locations) or audio cues for those users who have a visual impairment (http://www.nfb.org/vod/vsum0001.htm)."

Medtronic Minimed

Medtronic MiniMed was founded in 1949, and "since developing the first wearable external cardiac pacemaker in 1957 and manufacturing the first reliable long-term implantable pacing system in 1960, Medtronic has been the world's leading producer of pacing technology, and is the world's leading producers of insulin pumps and continuous glucose monitoring systems. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease (http://www.minimed.com/patientfam/pf_ipt_paradigm_pump_overview.shtml)." The company's main line of insulin pumps is the Paradigm® Platform.

Paradigm® Insulin Pump

The "Paradigm® insulin pump is not just an insulin pump, it is a platform for ongoing innovation, designed to be upgraded like a computer. Only this platform has three generations of innovation, with each new generation built on the foundation of innovations that preceded it, providing ongoing improvement in flexibility and control (http://www.minimed.com/patientfam/pf_ipt_paradigm_pump_overview.shtml)."

The three generations of the platform are:

GENERATION 1 (2002)- Platform concept unveiled. An E-Z PATH™ menu and multiple basal and bolus options provided improved effectiveness and ease of use.

GENERATION 2 (2003) - The Paradigm® 512/712 insulin pump. 'Smart pump' features introduced such as the Bolus Wizard® Calculator, which does the diabetes math for an individual to suggest a bolus amount.

GENERATION 3 (2004) - The Paradigm® 515/715 insulin pump. Innovations include the Web-based Medtronic CareLink® Therapy Management System, which charts A1C, BG, carbohydrates and other trends to help optimize therapy (http://www.minimed.com/patientfam/pf_ipt_paradigm_pump_overview.shtml)."

The Paradigm® 515/715 Insulin Pump

MiniMed utilized research over the past 20 years to create its Paradigm® 515/715 insulin pump. The pump, which is available in four colors, is designed to "emphasize ease of use, optimize safety, and ensure continuous, flexible insulin delivery (http://www.minimed.com/patientfam/pf_ipt_paradigm_pump_overview.shtml)."

These three important aspects of the pump "include:

Simple- Easy menu navigation simplifies insulin pump use.

The Paradigm Link® Blood Glucose Monitor, powered by BD Logic™

Technology automatically beams blood glucose results to the Paradigm® insulin pump.

Safe- Millions of safety checks each day ensure continuous, reliable performance.

Built-in prompts and reminders help the user to stay on track for good control.

Smart- Bolus Wizard® Calculator simplifies insulin dosing and reduces math errors.

It uses a scientific 'insulin action curve' to factor in the amount of active insulin left in the body http://www.minimed.com/patientfam/pf_ipt_paradigm_pump

_overview.shtml)."

The Paradigm Link® Blood Glucose Monitor which is used by the pump is the "first monitor available for wireless communication with an insulin pump, and is one of the most advanced, easy-to-use meters for blood glucose testing. The monitor's combined features help ensure less pain for greater comfort and innovative convenience for every test -- "every day (http://www.minimed.com/patientfam/pf_ipt_paradigm_pump_overview.shtml)." The monitor, which requires a smaller blood sample than other monitors, uses the thinnest lancets available to decrease pain by at least 50%, and takes only 5 seconds to perform the test. The monitor allows 515/715 pump users to "download insulin, carbohydrate and blood glucose information to Medtronic CareLink® Therapy Management System for Diabetes. The software organizes the information into charts, graph and tables, allowing the patient and healthcare provider to spot trends and make better decisions about diabetes therapy (http://www.minimed.com/patientfam/pf_ipt_paradigm_pump_overview.shtml)." The wireless technology allows the user to hide the pump under clothes, unlike some pump/monitor combinations which are bonded into one unit that is thicker and more cumbersome.

Paradigm® 522/722

MiniMed is currently testing its new "Paradigm® 522/722, the world's first sensor-augmented insulin pump system, and plans to have it commercially available in the near future. This fully-external system will be designed to utilize a subcutaneous glucose sensor,…