Sensor-augmented insulin pump therapy for type 1 diabetes

We've seen some major advances in diabetes, insulin pumps, and glucose meters. I'm still waiting for the day when someone will announce that we have a fully functional artificial pancreas that doesn't require any user-input.  Then, we'll have a truly closed-loop system that doesn't require any modifications from the user. A patient with type 1 diabetes could eat anything and this artificial pancreas would adjust the insulin dosages and regulate blood sugar like a real pancreas.

The New England Journal of Medicine (NEJM) recently published several articles about some technology advances in the care of patients with diabetes. Those articles are:

• Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes
• Continuous Glucose Monitoring — Coming of Age

We're probably going to see an increase in the use of continuous glucose monitors among patients with either type 1 or type 2 diabetes. Will this eventually become the "standard of care?" Right now, many people are unable to afford continuous glucose monitors and sensor-augmented pumps. How will this change over the next decade? Perhaps the biggest question is: who's going to pay for this expensive technology? If you're on the government-sponsored "public option" insurance plan, will you get coverage for this type of technology?

FDA Alert: Stolen insulin

FDA Warns About Stolen Insulin
Update to June Alert

The U.S. Food and Drug Administration is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market.

Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. The FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

When the FDA first alerted the public to the theft in June, it reported that three lots of Levemir totaling 129,000 vials had been stolen in North Carolina. So far only about 2 percent of the total amount stolen has been recovered.

The FDA continues to aggressively investigate this matter and is asking for the public's help in reporting any information regarding these vials to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036; XZF0037; XZF0038. You can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your health care provider because another insulin product may require adjustments in dosing.

3. Always look at your insulin carefully before using it. Levemir is a clear and colorless solution.

FDA NEWS RELEASE
For Immediate Release: August 26, 2009
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Medtronic recalls certain Paradigm® Quick-Set® Infusion Sets

If you have diabetes and you're using a Medtronic MiniMed Paradigm insulin pump, you'll want to read this:

According to the FDA, Medtronic, Inc. has initiated a voluntary recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Medtronic recently discovered that approximately two percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly.

Patients should discontinue using “Lot 8” Quick-set infusion sets.

Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of “Lot 8” Quick-set infusion sets. Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge. To view the entire FDA press release, click here.

Transdermal Continuous Glucose Monitoring (tCGM) System

It's about time someone came up with a non-invasive glucose meter. Looks like echo therapeutics may have something really novel here. Their Symphony transdermal CGM system uses no needles and provides continuous glucose readings and trends.

Once again, the wireless transmitter uses Bluetooth technology. Security standards will need to increase if sensitive health information is being transmitted wirelessly. What types of security protocols and data encryption will be necessary?

It's really exciting to see all the R&D advances focusing on the "artificial pancreas." Soon, people with diabetes may have automated devices that monitor and control their glucose levels. Wouldn't that be something?