Medical Device Daily
At the annual meeting of theAmerican Diabetes Association (ADA; Alexandria, Virginia) – specifically, the 67th scientific sessions —that began Friday and continues through today in Chicago, Medtronic (Minneapolis) reported the launch of a new physician component to its CareLink Therapy Management System for Diabetes.
CareLink Pro Software, an “advanced therapy management” software for healthcare professionals, is designed to allow quick and easy analysis of critical diabetes management data, and identify cause/effect relationships in therapy that may enhance office visits and optimize treatment decisions.
CareLink Pro Software, for healthcare professionals, is the particular software being introduced at the conference. However, combined with CareLink Personal Software, for patients, the two provide an integrated approach to diabetes control by simplifying data management associated with regular diabetes management, according to the company.
Initially, at least, the Carelink Pro will be targeted to endocrinologists, who treat most patients with the Type 1 form of diabetes, Medtronic spokesman Steve Sabicer told Medical Device Daily from the conference.
“Because the majority of the people who use our therapies and CGM [device] are Type 1 patients, we are initially targeting those patients to utilize this type of data management,” Sabicer said. “However, ultimately we think that this technology, this software, has significant value for all patients with diabetes to aggressively manage their disease.”
The physician-based software is designed to allow professionals to retrieve a patient’s data from the Internet after the patient uploads the data using his or her CareLink Personal account. The software platform also provides robust reports with data from the insulin pump, continuous glucose monitoring (CGM) sensor, and meter to solve the puzzle of glucose control, Medtronic said.
“We expect these new physician tools to greatly simplify pump therapy initiation and the ongoing ‘fine tuning’ adjustments associated with maintaining healthy blood sugar control,” said Chris O’Connell, president of the Diabetes business at Medtronic.
O’Connell said that due to large patient caseloads, many endocrinologists are often overburdened and have less time to spend with each patient, so Medtronic believes that better information and closer communication between physician and patient will help improve diabetes management and therapy outcomes.”
Medtronic says that the CareLink Personal Software system is the only software that integrates meter, logbook and continuous glucose monitoring (CGM) data, thus helping patients learn how insulin, carbohydrates and exercise affect their diabetes. Detailed treatment reports feature charts and graphs, and reveal patterns and problems often overlooked by traditional meter software or paper logbooks.
Sabicer told MDD that a “patient who uses an insulin pump, a CGM and a finger stick meter ... they have a lot of data that they get from those devices.”
That data can be difficult to manage, and the thought behind the software for patients is to make these calculations easier to manage and more useful. Now, the professional version of the software is expected to provide almost virtual patient management for physicians.
All CareLink Software is compatible with most major blood glucose meters and is available for the MiniMed Paradigm REAL-Time Insulin Pump Systems. The patient software also supports the Guardian REAL-Time Continuous Glucose Monitoring System; CareLink Pro is expected to support the Guardian REAL-Time System in the near future.
In research presented at the ADA conference:
Data concerning the GlycoMark 1,5-anhydroglucitol (1,5-AG) blood test indicates its ability to detect underlying treatment effects in patients with diabetes. These treatment effects were not readily revealed by the “gold standard” hemoglobin A1C diabetes test.
GlycoMark is commercialized by a partnership between Toyota Tsusho America (New York), Nippon Kayaku (Tokyo) and the BioMarker Group (Kannapolis, North Carolina).
Although the A1C test provides important information about how blood glucose has behaved over the preceding two or three months, the test does not provide specific information on blood glucose performed right after meals. This is a critical measurement because a growing body of evidence suggests that controlling after-meal glucose levels plays a significant role in achieving optimal glycemic control and reducing the burden of cardiovascular complications, the leading cause of death in patients with diabetes.
In contrast, GlycoMark provides a specific measure of average after-meal glucose levels over a period of one to two weeks with one single blood test — revealing potentially abnormal after-meal glucose elevations that would otherwise go undetected by the A1C test.
In a recent study published in Diabetes Care, the journal of the ADA, it was shown that the GlycoMark 1,5-AG test reflected after-meal glucose levels more robustly.
than the A1C test. The study also showed that GlycoMark was able to reveal dramatically different after-meal glucose levels in patients with similar A1C levels.
The studies also show that GlycoMark is valuable in detecting underlying treatment effects on after-meal glucose levels.
GlycoMark is an FDA-approved test for monitoring intermediate glycemic control by measuring the levels of a monosaccharide 1,5-anhydroglucitol (1,5- AG) in blood.
GlycoMark is being used in clinical practices nationwide and is available at major reference laboratories including Quest Diagnostics (Lyndhurst, New Jersey), LabCorp (Burlington, North Carolina) Esoterix (Austin, Texas), Mayo Medical Laboratories (Rochester, Minnesota), and Specialty Laboratories (Valencia, California).
The test is also available at most major contract research organizations for pharmaceutical research studies.