Stop Using GenStrip Test Strips, FDA Warns
The US Food and Drug Administration (FDA) has warned that GenStrip blood glucose test strips, sold by Shasta Technologies, may give incorrect blood glucose readings and should not be used. The FDA issued the statement after an inspection of the company found extensive quality control violations.
The test strips are third-party products, meaning they are not produced by the same company that produces the meter in which they are used. GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters.
The strips in question have been manufactured and distributed since March 2013 and are available through retail pharmacies and online retailers. They may be packaged in green and white packaging with the GenStrip name on top.
“Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels. An inaccurate blood glucose reading could lead to inappropriate or delayed treatment that could significantly harm a patient,” the FDA noted.
To date, the manufacturer has been unwilling to voluntarily recall the strips, resulting in their continued availability. The FDA is recommending that people with diabetes discontinue use of the strips and obtain alternative strips that are intended for use with the LifeScan OneTouch family of meters. They are also advising retailers to discontinue sale of the product.
Any adverse reactions or problems relating to the use of this product should be reported to MedWatch, the FDA’s safety and adverse event reporting program, by telephone at (800) FDA-1088 (332-1088), by fax at (800) FDA-1078 (332-1078), on this webpage, with the postage-paid FDA form 3500 (available here), or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
For more information, see the FDA’s safety communication.
High-Protein Breakfast Good for Blood Sugar
Research has shown that extreme increases in glucose and insulin can cause poor blood glucose control and increase a person’s risk of developing diabetes. Now, new research from the University of Missouri-Columbia indicates that eating a high-protein breakfast leads to better glucose and insulin control throughout the morning in women without diabetes.
To determine the effects of breakfast composition on blood glucose levels, the researchers looked at women ages 18–55 years old who had either one of three different meals or only water on four consecutive days. The meals all contained less than 300 calories and had similar fat and fiber contents but varied in the amount of protein they contained: 3 grams for a pancake breakfast, 30 grams for one variety of sausage-and-egg breakfast skillet, and 39 grams for another variety of sausage-and-egg breakfast skillet. The women’s glucose and insulin levels were monitored for four hours after they ate breakfast.
The results showed that the consumption of the high-protein breakfasts led to better blood glucose control throughout the morning compared to consumption of the low-protein, high-carbohydrate breakfast: Both high-protein breakfasts caused lower spikes in glucose and insulin. Moreover, the meal containing 39 grams of protein led to lower post-meal spikes than the meal containing 30 grams of protein.
“Since most American women consume only about 10–15 grams of protein during breakfast, the 30–39 grams might seem like a challenging dietary change. However, one potential strategy to assist with this change might include the incorporation of prepared convenience meals, such as those included in this study,” noted study author Heather Leidy, PhD. “If you eat healthy now and consume foods that help you control your glucose levels, you may be protecting yourself from developing diabetes in the future.”
The study will be presented at the 2014 Experimental Biology meeting in San Diego, California. Further research is needed to confirm whether the consumption of high-protein breakfasts can help with morning blood glucose control in women with prediabetes (a condition in which blood glucose levels are elevated, but not high enough to be diagnosed as diabetes).
For more information, see the piece “Consuming high-protein breakfasts help women maintain glucose control, study finds.” And for more information on controlling after-meal blood glucose spikes, read the article “Strike the Spike II,” by the AADE’s 2014 Diabetes Educator of the Year, Gary Scheiner.