A consortium of four institutions, including the Icahn School of Medicine at Mount Sinai, is conducting first-of-its-kind research into an artificial pancreas, a closed-loop system designed to address the unique challenges associated with type 1 diabetes (T1D). was carried out. ) pregnant. Dr. Camilla Levister, MS, ANP-C, CDCES, a nurse at the Icahn School of Medicine at Mount Sinai Hospital in New York, discusses the nuances of testing an artificial pancreas system in pregnant women and the use of such systems. It gives an insight into the potential benefits. Manage T1D in this population.
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Can you talk about the burden of T1D self-management during pregnancy and the challenges of conducting research on closed-loop systems in this population?
Type 1 diabetes has its own daily challenges when it comes to managing blood sugar levels. Pregnancy and diabetes have different goals as opposed to managing diabetes alone outside of pregnancy. Her type 1 diabetic woman’s fasting blood sugar goal during pregnancy is less than 90. [mg/dL]less than 140 1 hour after meals [mg/dL]. Typical fasting blood sugar levels for people with type 1 diabetes are between 80 and 130, according to the American Diabetes Association. [mg/dL], for example. So it’s a little different than having a fasting blood sugar level of less than 90. [mg/dL] For pregnant people. Add to that the stress factors of pregnancy.
When many of us think of someone being pregnant, we think of two people having a meal and wanting something like ice cream or pickles. And if you have type 1 diabetes, you always have to keep in mind, “How will all these different food choices affect my blood sugar levels?” How does activity affect my blood sugar levels?” Not only do you want to make sure your blood sugar doesn’t get too high, but you also want to avoid hypoglycemia. And that, on top of the overall stress of pregnancy and your own health concerns, can also take a toll on your baby’s health. You’re not the only one you’re caring for right now. For the next nine months or so, you will be caring for the child inside you. Apart from that, you have to raise children.
All the while, you’re actually watching your blood sugar levels. As health care providers, we help our pregnant patients stay within the blood sugar goals mentioned above. But even if a highly motivated person does everything recommended, achieving those goals can still be difficult. That’s why we turned to technology to see if it could help our patients achieve these goals so they can have healthy pregnancies. The American Diabetes Association has consensus guidelines for continuous blood glucose monitoring goals during pregnancy. Continuous blood sugar monitoring has become important in pregnancy, and now it’s finally approved for use with the Dexcom G7 sensor. In the past and during these trials, continuous glucose monitoring was used during studies, but it had not yet been formally approved for pregnancy. And the concern was not that the sensor itself would necessarily have any effect on the fetus. The concern was that the blood sugar targets are so strict that you have to make sure what you’re seeing is actually representative of what’s happening with glucose, and therefore accurate enough. That’s what it means. So that was another thing we had to consider during these trials.
Mount Sinai is part of a consortium working on artificial pancreas technology for T1D during pregnancy. What are the notable results and findings?
Around 2019, some of the Mount Sinai researchers involved in diabetes and pregnancy research got together with the Mayo Clinic, Harvard University, and the Sansom Diabetes Institute. [Research Institute], aims to establish a consortium to address the need for pregnancy technology for women with type 1 diabetes. And their goal in doing that was to come up with a pregnancy-specific hybrid closed-loop insulin delivery system, an artificial pancreas system that could meet pregnancy goals, more stringent blood sugar goals. And, most importantly, do they have better results than women who don’t use this technology?
The first part of the study was an observational study using this. [National Institutes of Health] Grant. And in that study, participants wore Dexcom continuous glucose monitors and used a proprietary insulin pump system. They were using an insulin pump system that was not in closed-loop or artificial pancreas mode. So basically all the settings that the provider made were what was available to the patient. If they wanted to adjust things, or their healthcare provider made adjustments, or if they wanted to stop insulin or stop it at a certain time, they did it. However, they were not using a dynamic hybrid closed-loop system. And approximately 7 of the 25 participants reached the in-range goal of at least 70% of glucose between 63 and 140 mg/dL.1 We then conducted an intervention study using this pregnancy-specific hybrid closed-loop insulin delivery system, which was a very small trial of 10 participants; Nine of the people were able to administer insulin. To achieve the goal of 70% or more,2 It’s huge. It may also reduce the burden of pregnancy due to type 1 diabetes. As mentioned earlier, you already have enough responsibilities when it comes to the day-to-day management of your diabetes, especially when you have to think about others as well as yourself.
reference
1. O’Malley G, Ozaslan B, Levy CJ, et al. Longitudinal observation of insulin use and glucose sensor metrics in pregnant women with type 1 diabetes using continuous glucose monitors and insulin pumps: the LOIS-P study. Diabetes Technol. 2021;23(12):807-817. doi:10.1089/dia.2021.0112
2. Levy CJ, Kudva YC, Ozaslan B, et al. Home use of a pregnancy-specific zone MPC closed-loop system for pregnancies complicated by type 1 diabetes: a single-arm observational multicenter study. diabetes care. 2023;46(7):1425-1431. doi:10.2337/dc23-0173
