Study participants gain access to education and new technology
By Susanne Martin, Managing Editor
Managing type 1 diabetes is not easy, especially during pregnancy, and improved glycemic control – keeping blood glucose levels within a tight range – has been linked to better pregnancy outcomes for both mothers and babies. “Hats off to the women – they work incredibly hard to have healthy babies,” says Lois Donovan, medical director of diabetes in pregnancy in the Calgary zone of Alberta Health Services.
Dr. Donovan says she dreams of the day when major advances in therapies will ease the way for pregnant women with type 1 diabetes (T1D). She also supports steps in that direction and has taken on the role of principal investigator of the Calgary arm of the JDRF Canadian Clinical Trial Network Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial (CONCEPTT).
CONCEPTT is the first large-scale international trial that evaluates the benefit of adding a real-time continuous glucose monitoring (CGM) sensor to standard therapy. A CGM system consists of a small sensor inserted in the skin that transmits blood sugar readings every five minutes to a monitor similar to a pager, says Dr. Donovan.
Only one of the two randomized groups in the study utilizes CGM technology in combination with traditional monitoring but Dr. Donovan sees participation as a “win-win for all participants, since both groups learn a lot about diabetes and pregnancy.”
Although trial results are not available yet, she has already noticed benefits. “Being part of CONCEPTT has given our centre the opportunity to get more experience with continuous glucose sensors,” she explains.
Dr. Donovan works closely with Denice Feig, head of the diabetes and endocrinology in pregnancy program at Mount Sinai Hospital, Toronto, and Helen Murphy in Cambridge, U.K., who are co-principal investigators overseeing Canadian and international sites.
Dr. Murphy, senior research associate at the University of Cambridge’s metabolic research laboratories, sees the trial as a very timely addition to diabetes research.
Of the two cohorts participating in the trial – women who are planning pregnancy and expectant mothers – she says they are “very motivated to do everything within their power to get as much blood sugar control as possible.” This motivation already improves the odds for study participants, says Dr. Murphy, who believes making CGM technology available to a “good range of women” is another important aspect of CONCEPTT.
Among her patients, for example, was a Roma woman with extremely low literacy levels who – although she didn’t know the numbers – was able to read the monitor and “did phenomenally well, delivering a healthy baby,” says Dr. Murphy.
This is an example where an expectant mother greatly benefited from having access to a CGM system, Dr. Murphy explains, adding that another trial participant expressed the sentiment that after using CGM, regular blood glucose monitoring felt like “driving a car with a blind fold.”
Dr. Murphy hopes the outcomes of the study “will help to get the devices to all eligible candidates.”
Dr. Donovan says the sharing of data and advice has not only helped her caring for the study participants but has also informed her larger practice. The support available to women with diabetes includes access to an endocrinologist, a diabetes nurse and a dietician, explains Dr. Donovan. “Managing diabetes and pregnancy is a real team effort and the person who works the hardest is the mother,” she says.