Important takeouts:
Management of glucose levels during pregnancy in women with type 1 diabetes is important for mothers and children. New techniques have helped women with type 1 diabetes maintain target glucose levels during pregnancy.
Chicago – Pregnant women with type 1 diabetes using hybrid closed-loop insulin delivery with control IQ technology spent more time in the pregnancy range per day compared to women who followed standard care, trial results show.
Furthermore, results presented at the American Diabetes Association's scientific session showed that the use of the technology among pregnant women with type 1 diabetes had “unexpected safety concerns.”
The circuit test evaluated the efficacy and safety of hybrid loop loop insulin therapy treatment regimens. This was done using an embedded control algorithm (control IQ technology) to automatically regulate insulin delivery using continuous glucose monitor readings. The system is currently available but is not approved for pregnancy.
Open label trials enrolled women with type 1 diabetes who had HBA1C between 6% and 10% in the early stages of pregnancy. 91 women (mean age, 32 years) at 14 Canadian and Australian centres were randomly assigned to initiate hybrid closed-loop insulin therapy using control-IQ technology until 16-week pregnancy (n = 46) or continuous standard care with CGM (n = 45). Women were advised to follow the lowest target range. Baseline HBA1C was 7.4%, with participants having varying duration of diabetes (mean, 19 years ± 8 years).
The results presented here show that women in the hybrid loop insulin therapy group had a 12.5 percentage point higher in 65% (p <.001) compared to 65% (p <.001) pregnancy range from 63 mg/dL to 140 mg/dL pregnancy time between 16 and 34 weeks.
Lois E. Donovan
“We found an amazing 12.5% good time in the range of people using it. [hybrid closed-loop insulin therapy with] FRCPC, Lois E. Donovan, MD and Lois E. Donovan, MD and Lois E. Donovan, at the ADA Science Session, Clinical Professor of Medicine and Obstetrics and Gynecology at Cumming School of Medicine at the University of Calgary, spoke to Hillio.
“Pregnant women using this system spent a total of three hours per day, and a significant amount of time in the pregnancy range.
Other results show that women using the system were below the range of pregnancy (33% vs. 40%; -11.5% adjusted difference; p <.001) beyond the range (2.1%, 2.1%; -1% adjusted difference; p <.001).
Denice Feig
Safety was similar between the two groups. Serious adverse events occurred in two participants in the closed loop group and five in the standard care group. There was one incidence of severe hypoglycemia in each group. Results show that diabetic ketosidosis occurred in two participants in the closed loop group and two participants in the standard care group.
Dennis Feig, Maryland, an endocrinologist at Mount Sinai Hospital in Toronto and a clinical physician scientist at the University of Toronto, told Helio there was no learning curve for participants assigned to use a hybrid closed-loop system.
“It was really easy [for participants] To learn about the device, Feig told Healio. “Part of the challenge is when women get pregnant, they really need good control and if they haven't done it before pregnancy, they have to do it really immediately during pregnancy.”
perspective
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I look forward to the results of the cyclical exam that studied control IQ during pregnancy. The outcome was not disappointing. Previously, there was a case series and retrospective data showing the potential for a control IQ automated insulin delivery (AID) algorithm during pregnancy, but this is the first randomized controlled trial comparing pumps to standard care.
This study included a relatively diverse population of 91 women with type 1 diabetes in early pregnancy, with that time in the range of pregnancy increasing by 11.4% in the control IQ group to 65.4%, with 1% <63 mg/dl and mean glucose reduced by 11.2 MG/DLIN compared to the control group. This is extremely clinically important and reinforces what we have done in our clinical practice when using this system off-label to achieve pregnancy goals. This is similar to the results of the AIDAPT study despite the ability of the pump to have lower glucose targets. Additionally, this is an important option as the algorithms used in CAMAPS, AIDAPT research are not available in the US. It has new features of Control IQ+, such as temporary basal speeds and long extended bolus, which could help you achieve even greater time within the scope of your clinical practice. I look forward to reading the full publication and learning more about pump management for the exam, along with trends in obstetric and neonatal outcomes.
Diana Isaacs, Pharmd, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
Helio | Endocrine Today's Editorial Board Member Endocrine Pharmacy Expert Co-Director, Pregnancy Disorders at Cleveland Institute for Clinical Endocrine and Metabolic Research
Disclosure: Isaacs reports speaking or consulting for Abbott, Dexcom, Insulet, Medtronic, sequels, and tandem.
Source/Disclosure
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sauce:
Donovan Le, and others 2084-lb. Presentation: American Diabetes Association Scientific Sessions; June 20-23, 2025. Chicago.
Disclosure: This study was funded by a non-commercial, competitive research grant. Donovan reports that in-kind product support Dexcom, Inner Analytics, Medtronic and Tandem diabetes care are being taken to conduct research. FEIG reports on YPSOMED consulting and Novo Nordisk.
