Improving health during pregnancy for those with Type 1 diabetes

An international study co-led by University of Calgary researchers has found new insulin delivery technology helps control glucose levels during pregnancy for those with Type 1 diabetes, which is crucial to the health of women and their newborns.

The technology, known as automated insulin delivery (AID), mimics a healthy pancreas. The system automatically adjusts the amount of insulin given by a pump in real-time, based on current and predicted glucose levels.

“For pregnant women with Type 1 diabetes, keeping glucose within a healthy range is very important to the health of the woman and fetus,” says an endocrinologist at Foothills Medical Centre in Calgary and Cumming School of Medicine researcher Dr. Lois Donovan, MD, the study co-principal investigator.

In a multicenter clinical trial, published in JAMA, researchers evaluated the impact of a hybrid closed-loop (HCL) insulin therapy treatment regime with standard insulin injections or an insulin pump that was not automated, along with continuous glucose monitoring.

“Keeping blood glucose in the optimal range for pregnancy is exceptionally challenging when someone has Type 1 diabetes, despite their best efforts and the support of dedicated health care clinics,” says Dr. Denice Feig, MD, the study’s other co-principal investigator. She is an endocrinologist and clinician scientist at the Lunenfeld-Tanenbaum Research Institute, Sinai Health, and a professor of Medicine at the University of Toronto.

Risks in pregnancy

Risks associated with Type 1 diabetes in pregnancy can include increased chances of miscarriage, preeclampsia, which involves dangerous spike in blood pressure, and other significant health concerns. Newborns of pregnant women with Type 1 diabetes are more likely to be born excessively large or early and have low blood glucose at birth and are at higher risk of birth defects.

“The study found this AID system worked in pregnancy. It resulted in a three hours per day improvement in the time spent in the desired glucose range compared to the standard delivery with insulin injections or regular insulin pumps,” says Donovan. “This is very important because we have learned from other larger studies that every 72 minute per day increase, with glucose in the desired range during pregnancy, is associated with reduction in newborn complications.”

The AID system used in the study is knowns as a Tandem t:slim X2 insulin pump with Control-IQ technology.

“We’ve known for a while that AID systems have achieved better glucose control with less diabetes management burden in non-pregnant people with Type 1 diabetes, but its use had not been well studied in pregnancy,” Donovan says. “Most AIDs were not designed to achieve the narrow glucose range desired in pregnancy or to adapt quickly enough to the changing insulin requirement of pregnancy.”

14 sites in Canada and Australia involved

The study found those using the AID spent more time in a healthy glucose level range and less time below and above the healthy range. The improvement in blood sugar control was immediate and persisted throughout the pregnancy. These results were found at all 14 sites involved in the trial.

“This finding will help inform people who are pregnant or planning pregnancy regarding the benefits of this AID system, which can help them achieve better glucose levels in pregnancy and hopefully better pregnancy outcomes” says Feig.

The University of Calgary was the lead site for the study with clinics involved in Calgary, Toronto, Vancouver, Quebec City, London (Ont.), Winnipeg, Halifax as well as Canberra, Melbourne and Sydney, Australia.

Funding for the study was provided by Diabetes Canada, MSI Foundation, the University of Calgary Clinical Research Fund, the Buckley Family Trust, the Mount Sinai Department of Medicine Research Fund. The Medical Research Future Fund of Australia funded the trial in that country. In kind, reduced cost and loan of study supplies was provided by Dexcom Canada, Tandem Diabetes Care and RxFood.

The study funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data, approval of the manuscript or decision to submit the manuscript for publication.

Lois Donovan, MD, is an endocrinologist and clinical professor in the departments of Medicine and Obstetrics and Gynaecology at the Cumming School of Medicine (CSM). She is a member of the Alberta Children’s Hospital Research Institute and O’Brien Institute for Public Health at the CSM.