Q&A: CGM ‘revolutionary’ for pregnant women with diabetes
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Key takeaways:
- CGM use may alleviate barriers for women with type 1, type 2 or gestational diabetes.
- CGM may improve neonatal outcomes for women with diabetes, but more research is needed for type 2 and gestational diabetes.
Continuous glucose monitors have the potential to alleviate burdens, improve neonatal outcomes and predict disease progression for pregnant women with type 1, type 2 or gestational diabetes, according to two diabetes experts.
“Exclusion of pregnant individuals and lactating individuals for clinical trials has kind of been baked into our system,” Camille Powe, MD, an endocrinologist at Massachusetts General Hospital and associate professor of medicine and obstetrics and gynecology at Harvard Medical School, said during an interview with James R. Gavin III, MD, PhD, chief medical officer at Healing Our Village, clinical professor at Emory University and Healio | Endocrine Today Co-editor. “As we see these successful trials in this population, hopefully we’re going to lower those barriers, and I think we need to train a new generation of researchers to look forward to doing studies in this population and not be afraid of what’s going to happen if they do a study in pregnancy.”
Gavin spoke with Powe regarding a big theme at the recent American Diabetes Association Scientific Sessions this year: CGM use in pregnancy.
Read the interview transcript, lightly edited for clarity, below and/or watch the Healio Video Exclusive series linked here:
- Video 1: CGM can now benefit pregnant women with type 1 diabetes
- Video 2: Equal access necessary to realize CGM benefits in pregnancy
- Video 3: CGM is potential tool during pregnancy, postpartum
[Video 1]
Gavin: There is excitement regarding new advances and new interventions in diabetes with GLP-1s and SGLT2 inhibitors in the last few years. These are not things that have been approved for pregnancy. Now, we see a major issue with the approval of CGM. It must be very frustrating to see new developments, and then they’re not approved for pregnancy. Tell me a little bit about that.
Powe: As a diabetologist and as a diabetes researcher, it’s been remarkable to see all the advances over the past 10 years in pharmacotherapies and in technology to help people living with diabetes. But unfortunately, as you say, there is a population that’s been sort of left out or left behind with many of these advances; and that’s pregnant and lactating individuals. The reason, of course, is because by default we often exclude pregnant and lactating people from our clinical studies for new therapies. Now, that is done from a good place to protect the health of women and babies, but it has unintended consequences, which is that when people are pregnant, they aren’t able to access some of these great technologies and advances, so they’re really left behind at a time where we know diabetes management is so critical for their health.
Gavin: Why is it now, in the last few years, that CGM technology has been approved in pregnancy? What changed?
Powe: I don’t have the answer, but I will say I think there’s been a lot of hard work from the research community and the diabetes in pregnancy community to sort of say, “Hey, this is a technology that may benefit pregnant people.” People with diabetes, especially people with type 1 diabetes, say pregnancy can be one of the most challenging times because it is just so critical to get those glucose levels as close to normal. Both patients and physicians and researchers demand this technology because they know that it may help their patients. While we are starting to have some great evidence, we still have a lot of work to do to catch up to the level of evidence that we have outside of practice.
Gavin: Now that we have the tool available to be used in the spectrum of pregnancy in women with diabetes or gestational diabetes, what differences do you expect with the availability of that technology to make now?
Powe: Based on the CONCEPT trial, which was a study published in 2017 that looked at randomized women with type 1 diabetes to use CGM or not, we saw modest benefits that CGM gave in terms of glycemia, and it had remarkable effect on neonatal outcomes. It was quite beneficial in terms of things like neonatal hypoglycemia and neonatal ICU admission. We saw that in type 1 diabetes, and that’s our best evidence for offering CGM to all pregnant people with type 1 diabetes. However, we don’t have that evidence in type 2 diabetes, and we don’t have it in gestational yet. There’s a potential to realize the benefits that we saw in type 1 and these other types of diabetes, but it’s really on us to start working on generating the evidence, and figuring out how to use this tool in different types of diabetes, because I think we’re very comfortable knowing how to use it best in type 1 affected pregnancies, but we may need different targets and different strategies in type 2 or gestational.
[Video 2]
Gavin: When we think about gestational diabetes, a very dynamic area that you’re very involved in, it would appear that we are now looking at the prospect that by appropriate use of technology like [CGM], we could eliminate large for gestational age babies. Is that a realistic possibility?
Powe: It’s a realistic possibility that maybe we could get that large for gestational age baby rate down to where it is in people without diabetes or without hyperglycemia in pregnancy. At these scientific sessions, a trial was just presented with some promising data on glucose and CGM in gestational diabetes. And what we don’t yet have is those neonatal outcome data that we all desperately want. But more than that, I shared a debate yesterday on whether it’s time for CGM in gestational diabetes now, or whether we have enough evidence. One of the points that was made there is that patients want this technology, because they don’t want to be doing four times daily finger sticks anymore, which is the standard of care in gestational. So, I think it’s a matter of us working hard to make sure we know what those CGM targets are in gestational diabetes, so that we can move toward using that technology in that population and optimizing outcomes.
Gavin: It seems that there’s a balance here, because there’s not only the issue of targets, but the quality of life issues. Pregnant women have been very adherent to the guidelines of doing the numbers of finger sticks, but that’s a burden, and now we can foresee that you can have a significant change in quality of life if you had a wearable that can give you that kind of data more often with a lot less intervention.
Powe: Absolutely, and in terms of understanding the effects of glucose on outcomes, it would also give us the opportunity to take that data and look at it and really identify what are those glycemic patterns that are causing these negative outcomes that we see in gestational diabetes and really understand the physiology and make advances in terms of the science and understanding of this condition.
Gavin: Pregnancy is one of those states, where women become very motivated, because they have a treasure to protect. They safeguard it and they will follow guidelines. Many will do extremely well, even if they have to stick themselves eight times a day, but there are others who have more trouble with that. That means that you can set up a hierarchy of some women who need this technology more than others, where there are those who have outcomes that this technology could make a big difference because of that lack of burden in terms of following those directions.
Powe: We have to be very careful, because many times when we roll out a new technology, we see those disparities creeping in of who has access to the technology. If we find a technology that works well and improves outcomes, it’s up to us to also make sure that we can equitably distribute that technology so that everyone can benefit, particularly the groups in this country who have been found to have greater maternal morbidity and mortality.
Gavin: Are there approaches or avenues that would make it possible to make sure that every pregnant woman who needs this technology can get it?
Powe: There’s some data, at least in type 1 diabetes, that because of the benefits that we’re seeing in, for example, the CONCEPT trial in terms of neonatal outcomes, that CGM was very cost-effective because when you improve neonatal ICU admission, then you’re really talking about lowering costs with a very cost-effective technology. So, we don’t have the data in type 2 or gestational yet, but I think that may help motivate payers, and others to give access to everyone.
[Video 3]
Gavin: One of the things that happens in women with gestational diabetes, some of them are fortunate enough to go back to normal glycemia and others will remain with type 2 diabetes. I’m wondering if there is now going to be any advantage that we have by having a tool like CGM in the post-delivery phase, to help with predictions and shape things in a way that could mitigate the development of type 2 diabetes and those women who might be at risk?
Powe: Yeah, this is a huge issue. One of the reasons that we do gestational diabetes screening is because we have the potential to prevent future diabetes and really affect health across the life span. We also know that the postpartum period, the first year postpartum, is a time when many people don’t follow up with health care because they’re so busy taking care of a newborn, or because of other responsibilities like jobs, limited parental leave, etc. So, this is a time when we really lose a lot of people who had gestational diabetes, and they don’t always get the proper follow-up and screening to prevent type 2 diabetes, which we know how to prevent based on the findings from the Diabetes Prevention Program. If there’s anything we can do to make finding individuals who are at higher risk for type 2 diabetes later or allowing them to make the lifestyle changes that we know work to decrease the risk of type 2 diabetes in the future, it would be great to do that. CGM is being investigated as a potential tool to do that.
Gavin: In terms of how CGM might be used as a tool, is there any way that we’re likely to see CGM emerge as a surrogate or as a substitute for doing oral glucose tolerance tests and doing the complex numbers of tests that women have to do to make sure that they’re meeting the appropriate targets? How is CGM going to figure early on?
Powe: Pregnancy is one of the only times that we’re still doing oral glucose tolerance tests, 2- or 3-hour oral glucose tolerance tests and people don’t like them. They’re very burdensome. There’s great interest in whether CGM can be a tool, not just for treatment or monitoring, but for diagnosis. There have been a couple studies presented at this meeting and others, demonstrating that there may be glycemic patterns early in pregnancy, that can predict who will have gestational diabetes later. Using CGM as a tool for diagnosis is an area of active investigation. It could be revolutionary if those studies are successful.
Gavin: What area do you think is going to be the next frontier? What’s going to be the next most exciting way in which CGM is going to play in pregnancy, whether it’s type 1 or type 2?
Powe: I take care of a lot of patients with preexisting diabetes, both type 1 and type 2. Type 2 in pregnancy is now more common than type 1. Previously, we had thought of type 1 as being the most common preexisting diabetes in pregnancy, but recently, in the last decade or so, the incidence of type 2 diabetes and pregnancy has really skyrocketed. Individuals with type 2 diabetes, unlike outside of pregnancy, almost universally need multiple daily injections of insulin a day as people with type 1 diabetes do. So, one thing I’m really excited about is the possibility of automated insulin delivery to help this group because it’s very challenging to meet these glycemic targets if you’re a person with diabetes. So, if we can leverage some of the new tools in automated insulin delivery (AID) to help achieve these pregnancy targets, I think that would be a phenomenal revolution, both in terms of improving outcomes, but also relieving this burden that people experience during pregnancy.
But like other devices, the AID systems largely have been developed for targets outside of pregnancy, limiting that access to people who are pregnant. Some developers and device companies are starting to see the potential application in pregnancy and there have been some recent studies that have come out and there’s new studies that are ongoing, looking at AID.
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