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Diabetes: Page 6
Self-testing helps drive demand for bustling HbA1c market
By
Bruce Carlson
HbA1c has been used since the 1990s to measure long-term glycemic control in diabetics. Glycated hemoglobin (glucose attached to the blood protein hemoglobin) is a well-established analyte for long-term evaluation of blood sugar control, but glucose has been the primary test for diagnosing the disease. Ideally, every insulin-dependent diabetic should be tested for HbA1c every three months.
October 27, 2019
FDA airs 'to do' list for devices in 2020
By
LabPulse.com staff writers
The agency's Center for Devices and Radiological Health (CDRH) released its list of planned new guidance documents, with some prioritized for next year, along with a request for input on whether certain older guidance documents should be changed or withdrawn.
October 13, 2019
Dexcom set to launch new clinic-owned continuous glucose sensors
By
LabPulse.com staff writers
The single-use product provides real-time monitoring of glucose data for patients and a retrospective analysis of glucose levels over a 10-day period. G6 Pro includes a disposable sensor, with no finger-stick blood tests needed for calibration or treatment decisions, according to the company. It is intended for monitoring blood sugar and adjusting therapy for patients who have not used their own systems before, and it complements the company's G6 personal CGM product.
October 8, 2019
Blood test spots diabetes complications early on
By
Joseph Constance
The development is significant for patients with type 2 diabetes because if vascular complications, such as heart disease, atherosclerosis, or kidney failure, are detected at an early stage, preventive treatments could be given to avoid severe clinical outcomes down the line.
October 1, 2019
ESMO blood test news | How to spot diabetes complications early | A visit with CAP's new president, Dr. Patrick Godbey
By
Emily Hayes
Dear LabPulse Member,
September 30, 2019
FDA seeks patient engagement in device design, development
By
LabPulse.com staff writers
The agency's "Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations" draft guidance proposes recommendations for various aspects of design for clinical trials of medical devices. The agency wants to garner direct input from patients as part of the medical device testing process that determines a benefit-risk profile for devices. Comments on the draft guidance will be accepted through November 22.
September 23, 2019
Utilization management gets a hand | POC experiment in diabetes | Should breast cancer genetic testing be broadened?
By
Emily Hayes
Dear LabPulse Member,
September 16, 2019
Point-of-care testing tackles diabetes risk in Texas
By
Joseph Constance
Public health officials in Denton County decided to take advantage of POC testing's unique capabilities to address a rising diabetes incidence rate among low-income people in their area. As a result of its efforts, the department boosted hemoglobin A1c (HbA1c) testing rates and achieved a 38% overall reduction in HbA1c levels in this target population.
September 11, 2019
More frequent HbA1c testing reduces diabetes costs
By
LabPulse.com staff writers
Diabetes affects more than 30Â million people in the U.S. each year, at an estimated cost of $327Â billion in 2017, including $237Â billion in direct medical costs. Compared to those without the condition, people with diabetes have two to three times the average amount of medical expenses, according to Primary PartnerCare.
August 27, 2019
Blood sugar test from GE's Drawbridge clears FDA
By
LabPulse.com staff writers
The company's announcement came on August 22, following clearance on August 15.
August 21, 2019
Celiac study reinforces need for appropriate testing
By
Emily Hayes
The new results come from the Environmental Determinants of Diabetes in the Young (TEDDY) trial, an international, observational birth cohort study of children genetically at risk for celiac disease and type 1 diabetes, due to their being carriers of the human leukocyte antigen (HLA) genotype.
August 13, 2019
AACC preview: A rough guide to diagnostics on show
By
Bruce Carlson
Some of the many developments we'll be looking for are described below.
August 1, 2019
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