The DTS-BGMS-Surveillance Program

The DTS Surveillance program for Cleared BG Monitoring systems is an independent program organized by the non-profit organization, Diabetes Technology Society. The Program is run by a Steering Committee with representatives from FDA, NIH, CDC, US Army, ADA, JDRF, TES, AADE, CAP, and AACC, as well as experienced leaders in glucose measurement from universities, hospitals, and industry. The Steering Committee includes experts in diabetes from the fields of adult endocrinology, pediatrics, diabetes nursing, clinical chemistry, mathematics, and basic science research, as well as the diabetes patient community. Leaders of surveillance programs for other devices measuring other blood chemicals and developers of widely used metrics for defining clinical accuracy of BGMS are on the committee. With this background of experienced knowledgeable leaders in blood glucose monitoring from the clinical and scientific perspectives, the Steering Committee of the DTS-BGMS Surveillance Program is responsible for developing and implementing a unique testing system and a unique reporting system for identifying acceptable or unacceptable BGMS performance. 

Objective Testing

The DTS-BGMS Surveillance Program tests the accuracy of BGMS as used by professional laboratory experts.  The program does not test the performance by patients because the purpose of this program is to test the BGMS under ideal conditions, rather than confusing the results with potential user error and various user techniques. The results are expected to be as accurate as possible for a system that is obtained through normal purchasing from regular suppliers. If systems are obtained from manufacturers, then in some cases the best equipment will be sent and possibly the systems will be better than those that are typically sold. In this program, however, we are seeking the typical types of products that will be purchased by patients. 

Human factors or ease of use are not tested by this program. The DTS-BGMS Surveillance Program is committed to obtaining objective performance data collected under optimal conditions by highly trained professionals using high quality testing equipment and high quality calibration.

Future programs may include performance of BGMS in the hands of the intended users, that is people with diabetes

Origins of the Surveillance Program

Because of a perception in the medical literature that cleared BGMS do not always perform up to the standards for which they were approved, Diabetes Technology Society presented a pair of meetings on this topic for the medical, scientific, regulatory, industry, and patient communities on this topic in the Washington DC area in 2013. At the first meeting in May 2013 the question was posed whether cleared BGMS perform up to the standards for which they were approved. The resounding conclusion was that often they do not. 

At the second meeting in September 2013 the question was posed whether a post-market surveillance program for determining the performance of cleared BGMS was the best approach to the problem of poorly performing products on the market. The resounding conclusion was affirmative and that such a program would be the best tool for identifying adequately and inadequately performing cleared BGMS on the market. DTS then engaged in extensive subsequent discussions with healthcare professionals, officials of nonprofit organizations devoted to diabetes therapy, industry executives, patients, representatives of FDA plus several other US government agencies responsible for healthcare during the following year about what was needed. In 2014 Diabetes Technology Society formed the DTS-BGMS Surveillance Program for Cleared BGMS. 

The DTS-BGMS-Surveillance Website

This website contains a list of BGMS that have been tested by the DTS-BGMS Surveillance Program. The test strips and monitors (i.e., blood glucose meters) are purchased by the program from the usual types of brick-and-mortar and online supply sources that most people with diabetes  use to purchase these supplies. 

This Program does not obtain products directly from manufacturers so there will be no question about whether the program is receiving and testing specially selected highly functioning products (such as specific, high performing test stip lots). 

The performance of the BGMS are presented on the website using a variety of statistical metrics. The program uses a specially developed formula for this program, which determines whether a BGMS has a high likelihood of adequate future performance (which leads to receipt of the DTS seal of approval) or a low likelihood of adequate future performance (which leads to not receiving the DTS seal of approval). 

It is critical that BGMS perform well in the low blood glucose range. However, it is not safe to induce hypoglycemia in subjects to obtain these blood samples. Therefore the glucose concentrations of some blood samples was lowered in a test tube after the blood was collected from the subject in order to obtain sufficient quantities of low glucose samples. Care was taken to assure that the act of lowering the glucose concentration did not affect the performance of the BGMS. If it did, the data was not used. 

Copyright © 2014 Diabetes Technology Society