Gestational diabetes mellitus (GDM) is a rapidly growing problem in many developing countries that demands an appropriate diagnostic technology. GDM can lead to serious complications for both mothers and babies at birth and also predisposes both to developing Type 2 diabetes mellitus postnatally. PATH is working to develop and evaluate a GDM point-of-care device that is low-cost, portable, and low-impact on patients. Currently, the Diagnostics Group focuses on Type 2 diabetes mellitus and gestational diabetes, as these two diseases comprise 95% of the diabetes cases in the world.
Dates of project
2011 – 2013
University of Washington Department of Laboratory Medicine
Madras Diabetes Research Foundation
Health Innovation Portfolio
The Saving Lives at Birth Consortium (via USAID)
Recommended screening for GDM is the Oral Glucose Challenge Test (OGCT). This requires fasting in preparation and a several hours stay at the clinic with multiple glucose measurements—leading to low patient compliance and loss to follow-up. Thus, implementing the OGCT protocol in pilot studies in developing countries has been only moderately successful.
A new biomarker, glycated albumin (GA), offers the potential to diagnose GDM within minutes without fasting. We propose adapting an existing laboratory assay for GA (an ELISA assay that requires laboratory equipment and significant training) and implement it as a semiquantitative rapid diagnostic test (RDT). PATH will develop the assay with samples obtained locally.
The proposed RDT for GA will allow health care providers to determine with good sensitivity and moderate specificity if a pregnant woman is likely to develop diabetes. Combining biometric information (weight, hip to waist ratio) and health history with the RDT result will improve specificity. The screening result can either be used to assign high-risk women into a group receiving counseling on diet and exercise as well as additional care during delivery or to receive a follow-up OGCT and insulin. With the RDT for the new biomarker, pregnant women (and health care systems) can avoid the cost and inconvenience of having every pregnant woman go through an OGCT as currently recommended by the World Health Organization, as well as increase patient catchment for diabetes screening.