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Latest FDA Articles
The Food and Drug Administration (FDA) has delayed until July 15th making a decision on whether to allow the inhaled insulin Afrezza entry into the American market.
4 comments - Posted May 24, 2014
Two years ago a Wisconsin man hospitalized for pneumonia was diagnosed with type 2 diabetes and prescribed 100 mg of Januvia, one of the common oral medications used for treatment. A month later, he was back in the hospital complaining about stomach pain and worried something else was wrong.
1 comment - Posted May 12, 2014
The inhaled insulin Afrezza has been recommended for approval by a Food and Drug Administration (FDA) advisory committee.
0 comments - Posted Apr 12, 2014
The U.S. Food and Drug Administration reports that its review of various animal and human studies does not show a link between GLP-1 drugs used to treat type 2 diabetes and pancreatic maladies, including acute pancreatitis and pancreatic cancer.
0 comments - Posted Mar 4, 2014
A total of 182 new drugs to treat diabetes or diabetes-related conditions are currently in clinical trials or undergoing review by the U.S. Food and Drug Administration, according to a report just published by the Pharmaceutical Research and Manufacturers of America (PhRMA).
0 comments - Posted Mar 1, 2014
DV-100, a drug designed to halt the body's autoimmune attack on pancreatic beta cells that leads to type 1 disease, has won orphan drug status from the U.S. Food and Drug Administration.
0 comments - Posted Jan 16, 2014
Can Januvia Trigger Cancer Symptoms?
2 comments - Posted Jun 12, 2013
A significant majority-20 of 26 members attending a combined meeting of FDA advisory committees-has voted to modify or remove the current restrictive label and distribution regulations affecting the type 2 drug Avandia.
0 comments - Posted Jun 9, 2013
People with diabetes know the score. We've all seen "revolutionary" drugs and treatments introduced with fanfare, and we know that that much of the time they're evolutionary at best. But something has changed in the world of diabetes care.
2 comments - Posted Jun 1, 2013
In a 10-5 vote, an FDA panel has recommended that the agency approve the marketing of Johnson & Johnson's InvokanaTM (canagliflozin), an oral once-daily drug for treating type 2 diabetes in adults.
0 comments - Posted Feb 1, 2013
The FDA has approved U.S. sales of Dexcom's G4TM PLATINUM continuous glucose monitor. The San Diego-based manufacturer said it is taking orders and plans to begin shipping the device to patients within the next few weeks.
2 comments - Posted Nov 16, 2012
Good news for Eli Lilly & Co., as well as for type 2s who appreciate the addition of new drugs to treat their condition: Lilly says its once-weekly injectible drug, dulaglutide, has outperformed three other widely taken diabetes drugs in three just-concluded Phase III studies.
0 comments - Posted Nov 5, 2012
As diabetes climbs to epidemic levels in the United States, and finding adequate resources to fund future U.S. healthcare remains in question, the need for an already existing "boots on the ground" group that can address the disease is greater than ever.
0 comments - Posted Aug 15, 2012
Medical devices aren't just any old pieces of technology. Lives depend upon them. For that reason, the government outlined a process decades ago by which manufacturers and importers were supposed to report malfunctions. But there was one problem: When malfunctions occurred, the manufacturers and importers did not admit it. According to the Food and Drug Administration, "A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported."
0 comments - Posted Jun 22, 2012
SAN DIEGO - June 15, 2012 - Dexcom, the leader in continuous glucose monitoring, is proudly sponsoring the efforts of the Diabetes Formation Flight USA(DFFUSA.org) - three pilots with insulin-dependent diabetes using Dexcom's Seven Plus as part of their effort to set new transcontinental world speed records while raising funds for the Juvenile Diabetes Research Foundation (JDRF).
0 comments - Posted Jun 20, 2012
The US Food and Drug Administration has approved the use of Novo Nordisk's Levemir basal insulin for type 1 children aged two to five years. The FDA decision makes Levemir (insulin detemir [rDNA origin]) the only basal insulin approved for use in this age group.
Levemir, introduced to the US market in 2006, was previously approved for older children and adults with type 1 diabetes, as well as insulin-using type 2s.
0 comments - Posted Jun 7, 2012
The US Food and Drug Administration has okayed US sales of Bayer HealthCare's CONTOUR® Next EZ blood glucose monitoring system. The new BGM, currently available in other countries as the CONTOUR XT, will be available in the US market this summer.
1 comment - Posted Apr 25, 2012
NeuroMetrix, Inc., a Massachusetts-based medical device company, has filed a 510(k) form with the US Food and Drug Administration for the SENSUSTM, a pain therapy device for people who suffer diabetic neuropathy. A 510(k) is a "premarket notification" of a company's intent to market a medical product. The FDA then tests the product and provides feedback to the manufacturer. Once the FDA clears the product, its maker can introduce it to the US market.
1 comment - Posted Apr 24, 2012
The latest clinical guidelines for treating type 2 diabetes from the American College of Physicians (ACP) indicate that when diet, exercise, and weight loss fail to control blood sugar levels in early type 2 patients, physicians should prescribe metformin as the first drug therapy.
2 comments - Posted Mar 1, 2012
There are lots of articles about diabetes, as well as all kinds of information about anemia. But what if you have both? About 25 percent of people with diabetes have some level of anemia. This article explains how the two conditions interact.
4 comments - Posted Feb 16, 2012
Barley has more beta glucan fiber than any other grain, and it has repeatedly established positive clinical results with regard to diabetes control. It not only boosts immune function by supporting macrophages and neutrophils, lowers blood pressure and cholesterol levels, and helps control obesity, but also attenuates postprandial glucose levels, improves insulin sensitivity, and promotes a feeling of satiety.
6 comments - Posted Feb 5, 2012
After several years of delays and setbacks, Amylin Pharmaceuticals has received FDA approval to begin US marketing of BydureonTM. The first once-a-week type 2 therapy to be offered in the US market, Bydureon is expected to be available by February. Amylin says that its wholesale price will be about $4,200 a year.
2 comments - Posted Feb 3, 2012
The FDA has given Roche the go-ahead to market its Accu-Chek® Nano SmartView blood glucose monitoring system. The Nano, which uses Accu-Chek SmartView test strips, will be available to US consumers within the first half of this year. It is part of the same product line as the Accu-Chek Aviva Nano and Accu-Chek Performa Nano systems, which Roche has already launched in several overseas markets.
3 comments - Posted Jan 22, 2012
A dietary supplement, also known as a food supplement or nutritional supplement, contains a "dietary ingredient" intended to supplement the diet by providing an element that might not otherwise be consumed. "Dietary ingredients" include vitamins, minerals, herbs and other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Dietary supplements, which may be extracts or concentrates, come in many forms, including tablets, capsules, soft gels, gelcaps, liquids, powders, and bars.
0 comments - Posted Jan 7, 2012
Spring Health Solutions, Inc., has released an instructional video describing its Spring Universal Infusion Set, recently approved by the FDA and Health Canada. The video, at www.SpringUniversal.com, is designed to help consumers properly use the product.
0 comments - Posted Jan 4, 2012
French drug maker Sanofi-aventis says that results from a Phase III trial of its experimental type 2 diabetes drug lixisenatide show that the drug successfully lowered patients' blood glucose levels and body weight, but did not increase the risk of hypoglycemia.
0 comments - Posted May 23, 2011