DRWF Research: How insulin delivery using technology works for pregnant mothers with type 1 diabetes
Researchers evaluate the safety and efficacy of hybrid closed loop (HCL) use during the first six months of pregnancy.
A new report has found that using HCL during pregnancy and after birth could be more beneficial for mothers with type 1 diabetes, over standard insulin delivering, in controlling glucose levels.
Most pregnant women with type 1 diabetes do not have glucose levels in the pregnancy-specific glucose target range, which may have negative consequences for the offspring.
Among non-pregnant adults and children, use of HCL insulin therapy has been associated with improved glucose control, but whether it can achieve more stringent glucose targets required for optimal pregnancy outcomes was previously unknown.
Researchers said: “Clinical guidelines in the UK and elsewhere do not specifically address HCL use in the postpartum period when the demands of caring for a newborn are paramount. Our aim was to evaluate the safety and efficacy of HCL use during the first six months postpartum compared with standard care.”
The study of 124 pregnant women with type 1 diabetes was held at various locations in the UK.
Study participants were randomly assigned to receive HCL therapy or standard insulin therapy and continuous glucose monitoring.
In early tests, the primary outcome was the percentage of time in the pregnancy-specific target glucose range (63 to 140 mg per decilitre) from 16 weeks’ gestation until delivery.
A recently published report in The Lancet Diabetes & Endocrinology details the findings of an extension to an earlier trial – Automated insulin delivery during the first 6 months postpartum (AiDAPT): a prespecified extension study.
Researchers said: “Pregnant women with type 1 diabetes at nine UK sites were followed up for six months postpartum.”
The postnatal extension trial ran from 12 November 2021 to 4 May 2023.
Detailing the study, researchers said: “Out of the 124 trial participants, 66 (53%) were not eligible for inclusion in the postpartum extension study, with 60 (91%) participants over six months postpartum and six (9%) participants who had discontinued HCL or control interventions (standard insulin with CGM) within the first six months. One participant in the control group had a neonatal death and the investigators considered it inappropriate to approach her about the extension study.”
Researchers found that “women continuing HCL from pregnancy into the postpartum period spent 15% more time within the non-pregnancy glucose target range, an additional 3-6 hours a day, compared with those assigned to CGM alongside standard care insulin delivery. Glycaemic improvements were met by a marked reduction in maternal hyperglycaemia, especially evident overnight, and the improvements were not accompanied by an increase in hypoglycaemia.
“In this study, although breastfeeding rates were initially low in the HCL group they were similar in both groups by six months postpartum, and comparable to national breastfeeding rates in the general maternity population, where prevalence of any breastfeeding is 55% at six weeks postpartum and 34% at six months postpartum.”
Researchers concluded: “The AiDAPT trial established the efficacy of HCL therapy during type 1 diabetes pregnancy with glycaemic benefits over and above CGM with standard insulin therapy. Our current findings support continued use of HCL from pregnancy into the postpartum period. Clinical benefits are sustained throughout the first six months postpartum compared to a marked deterioration in glycaemic control with CGM and standard insulin delivery.”
Dr Tara Lee, of the University of East Anglia, was awarded the DRWF Sutherland-Earl Clinical Fellowship in 2021 for her DILIGENT (Use of Diabetes technology on bIrthweight, Labour, Inpatient and postpartum Glycaemia of pregnant womEN with Type 1 diabetes) study, which contributed to the latest study.
Dr Lee said: “Despite increased use of continuous glucose monitoring (CGM) and insulin pumps, most pregnant women with type 1 diabetes struggle to manage their glucose levels in pregnancy. Many deliver large birthweight babies and experience additional challenges managing their diabetes during hospital admissions and after birth.
“My project will examine how the mother’s glucose levels and insulin therapy relate to baby’s growth patterns and birthweight and also how women manage their glucose levels when admitted to hospital and the first six months after having a baby. We know that after having a baby, their lifestyle changes quite a lot when there is a newborn baby to look after. We want to look at how their glucose levels change, how women cope with this and what we can do to help make this transition easier for them.”
Read the report in The Lancet Diabetes & Endocrinology
Read DRWF Research in focus: DRWF-funded research into type 1 diabetes in pregnancy
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