In part 2 of this Exclusive Interview, Grenye O’Malley talks with Diabetes in Control Publisher Steve Freed during the AACE 2018 convention in Boston, MA about the findings of the prenatal study of women with diabetes, both before pregnancy and during. Also, the impact of the CGM on pregnancy.
Grenye O’Malley, MD is an endocrinology fellow at Mount Sinai in New York.
Transcript of this video segment:
Freed: What were the findings of the study of your poster?
O’Malley: What we found was that the basal rates had a slight decrease in the early pregnancy which corresponds to when women are at highest risk of hypoglycemia and then around halfway through the pregnancy, they started to rise. We saw the biggest change in overnight settings. The most dramatic change was in the carbohydrate ratios which became less aggressive in early pregnancy but then had a steady increase to become much more aggressive. Those changed by about 50 percent.
Freed: What questions did your study arise?
O’Malley: So, there is still a lot more to know especially with the recent data like from the CONCEPT trial, which shows that glucose variability may be just as important as episodes of hypoglycemia or hyperglycemia. So, in populations where we try to limit our patients to people who have relatively good control going into their pregnancy, because we figured if some are very uncontrolled and then become motivated, some of those changes could be just optimization. However, even in those women who have an A1C of 6, we don’t know what all their variability was and how that could affect how then they need to have changes. So, the different tailoring – the changes to the specific woman depending on what their risks are and depending on what their pre-pregnancy BMI was – those are all things we have to learn.
Freed: What are the clinical findings of the study?
O’Malley: Well, I think that this kind of data that really puts more concrete numbers on what happens during pregnancy will help clinicians become more proactive in adjusting the settings. So, if you know what you think is going to happen in the next month, then that can affect what your recommendations are instead of only being reactive.
Freed: So, what can you actually tell people from the results of your study? So, you have someone who is pregnant come in, they are a type 1 diabetic, what did you learn that will help that type of patient?
O’Malley: Well, we learned we could predict that they may have the high risk of lows in the beginning of their pregnancy, which is why glucose sensors are going to be so important. But, looking at what their baseline control is – because we didn’t see that dramatic of a decrease in the early pregnancy – so really, tailoring that portion to the patient and then being comfortable enough to get a lot more aggressive with carbohydrate ratios as the pregnancy progresses.
Freed: Sometimes studies come out with results and they say, “Well we should have done this.” So, where did the results lead you to the next study that you would like to do?
O’Malley: So, we’re definitely going to try to get more prospective data. In this study, we worked with Mount Sinai and Mayo Clinic but we are going to expand that to even more sites because with limited numbers of patients, there is a bias of what your providers’ habits are and what they tend to do. We’re also looking at the CGM data to combine with the insulin pump data to get a more robust picture of the entire picture. And really just to get the same weeks, patients and more structured data to really look at the numbers in a more unified way.
Freed: Has the CGM made a big impact on pregnancy in diabetes?
O’Malley: I think definitely. Luckily, Mayo Clinic and Mount Sinai are good referral centers so a lot of patients came pre-pregnancy for planning and they were already on a CGM and tried to get as optimized as possible. But a lot of women only go on a CGM once they are already pregnant, especially with the newer sensors coming out that won’t have Tylenol implications, which for a woman who is pregnant, when they are limited to that, it can be really frustrating to not have that. And also, their limited sites, so a lot more study has to be in women to see what the real utility is of it how does this actually play out in them?