The desirability of close glucose control, highlighted by the Diabetes Control and Complications Trial (DCCT), led many diabetics to undertake multiple daily injections (MDI) to improve their diabetes management. But for some, this meant a heightened risk of hypoglycemic episodes. Insulin pumps had been available for some time and they now offered a possible means of achieving heightened glucose control without such a high risk of hypoglycemia through Continuous Subcutaneous Insulin Infusion (CSII).
In fact, Bode and Steed (Bode BW & Steed RD (1996), Reduction in Severe Hypoglycemia with Long-term CSII in Type I Diabetes. Diabetes Care 1996: 324–327) studied patients who had been using MDI and who had experienced recurrent hypoglycemia, and hypoglycemic unawareness. These patients transferred to CSII. The incidence of severe hypoglycemia declined more than six-fold during the first year of CSII, and remained significantly lower in years two, three and four on CSII. The frequency of diabetic ketoacidosis also declined with CSII from 14.6% to 7.2%. The average daily insulin dose one year after initiation was 15% lower than the MDI dosage. In this study, “patients maintained an excellent level of glycemic control, and achieved a significant reduction in the rate of severe hypoglycemia relative to pre-study management with MDI.” CSII therefore becomes the prime mechanism when there is a clear failure of MDI.
Due to innovation and increased acceptance, the global market for insulin pump and related disposables is growing in the double-digits, led by such companies as Roche Insulin Delivery Systems (formerly Disetronic) and MiniMed, which together hold the lion’s share of the market. With integrated glucose monitoring and insulin pump functions now FDA approved in an integrated (if not closed-loop) device by Medtronic (Paradigm), the prospects for insulin pumps in the diabetes management market are positive for both patients and those like Medtronic who stake out a solid position in this market.
An insulin pump is a small device about the same size as a pack of cards; it looks similar to a pager. Inside is a reservoir containing insulin, which is attached to the patient via a long piece of thin tubing. At the end of this tubing is a needle or cannula inserted under the skin, enabling the insulin to flow into the body. The pump is not automatic, but is programmed to deliver insulin constantly, at varying rates which the patient determines.
The pump only contains fast-acting insulin. Instead of administering insulin at certain times of the day, the pump delivers a constant flow. This has three main advantages:
- The patient can adjust insulin delivery spontaneously; the effect of any changes will be more or less immediate.
- The body absorbs fast-acting insulin better than the long-acting types. This means that less insulin is wasted, and that the action of the insulin is more predictable.
- The action of the insulin is much smoother and more constant, because a small amount is absorbed every few minutes, rather than a large amount once or twice a day.
According to the Juvenile Diabetes Research Foundation (JDRF), approximately 400,000 of the 3 million people in the United States with type 1 diabetes use insulin pumps, which became commercially available in the 1980s. Pumps offer flexibility and precision in controlling diabetes, which is a constant challenge for someone with diabetes. In fact, research shows that most people with diabetes spend the majority of the day with blood sugar levels outside recommended ranges, which can lead to devastating and costly short- and long-term complications.
Companies supplying or developing insulin pumps:
- Animas/Johnson & Johnson
- Asante Solutions, Inc. (formerly M2 Medical)
- Medingo Ltd./Roche
- Medipacs Inc.
- NiliMEDIX Ltd.
- Nipro Diabetes Systems Inc.
- Roche Insulin Delivery Systems, Inc. (formerly Disetronic Medical Systems Inc.)
- SOOIL Development Co., Ltd.
- Tandem Diabetes Care
Source: MedMarket Diligence Report #D510, "Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018."