New Studies To Test Automated Insulin Delivery in Pregnant Women with Type 1 Diabetes
By Jeemin Kwon
The first trial, now recruiting 50 people, is an observational study of insulin requirements and glucose levels using the Dexcom G6 CGM in type 1 pregnancy
Clinical Trials Identifier: NCT03761615
Trial name: Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy (LOIS-P)
Diabetes type: Type 1 diabetes
What the trial is testing: This study will observe glucose levels throughout pregnancy and post-birth in women with type 1 diabetes, who will wear a Dexcom G6 continuous glucose monitor (CGM). Participants will also be asked to self-monitor their blood sugar levels with routine fingersticks. Researchers hope to use the data collected in this study as a comparison point for data collected in future studies with pregnant women with type 1 using automated insulin delivery (hybrid closed loop) systems.
What the trial is measuring: The CGM will provide time-in-range data (defined as 63-140 mg/dl for this study), time spent below and above range, and frequency of severe hypoglycemia. Researchers are also measuring insulin requirements and comparing CGM data to fingerstick data. The study will also record maternal and fetal health outcomes.
Why is this new/important? This study will inform future studies of automated insulin delivery (AID) – also known as closed loop – in pregnant women with type 1 diabetes. Recognizing the unmet need and suboptimal health outcomes in both women and their babies, the US National Institutes of Health (NIH) awarded a research grant to Harvard, Mt. Sinai, Mayo Clinic, and the Sansum Diabetes Research Institute to evaluate a pregnancy-specific closed-loop system. (While a system like the MiniMed 670G is used “off label” in pregnant women with type 1, it is technically not approved for pregnant women yet.) In addition to providing baseline data for future studies, insights from LOIS-P will be used to develop and refine algorithms for a pregnancy-specific AID system.
Pregnant women with diabetes have a number of challenges: a much tighter target glucose range (the ADA recommends 95-140 mg/dl) and varying insulin resistance throughout pregnancy. A study published in the New England Journal of Medicine in 2016 showed that using AID in pregnancy – including during labor and delivery – drives much better time-in-range than manual insulin dosing. A tailored AID algorithm has the potential to better support this group, both in terms of time-in-range and quality of life.
LOIS-P was named after Dr. Lois Jovanovic, a trailblazing and inspirational endocrinologist and researcher who passed away last September. Dr. Jovanovic always dreamed of testing AID in pregnancy; in fact, she was one of the first advisors at diaTribe and oversaw all of diaTribe’s editor-in-chief Kelly Close’s three pregnancies.
Trial length: Duration of pregnancy plus up to six weeks after birth
Trial locations: Recruiting locations include Santa Barbara, CA, Rochester, MN, and New York City, NY. Click here for more details.
Would you like to take part? Select eligibility criteria include:
- Pregnant women 18 years or older with type 1 diabetes using an insulin pump
- A1C below 10%
- Currently using or willing to use an insulin-to-carbohydrate ratio to calculate meal bolus sizes
- Not using 670G on Auto mode
- Less than 17 weeks since conception
Where to get more information: Contact Shelly McCrady-Spitzer at 507-255-0316 or at mccradyspitzer.shelly@mayo.edu.
