New guidance on HCL devices for pregnant women with type 1 diabetes

Pregnant women with type 1 diabetes, and those planning pregnancy, should be offered pregnancy-specific hybrid closed-loop (HCL) technology, according to draft NICE guidance. The recommendation places the devices at the centre of safer preconception, antenatal and postnatal diabetes care.

The guidance would mean that all eligible women are offered systems that automatically monitor glucose and adjust insulin delivery through a pump, reducing reliance on finger-prick testing, manual injections and frequent treatment decisions. NICE states that these systems must be licensed for use in pregnancy, allow glucose targets within recommended pregnancy ranges and deliver at least 5% more time in range than standard care.

Tight glycaemic management before and during pregnancy is clinically important because both hyperglycaemia and hypoglycaemia can increase the risk of adverse outcomes for the mother and baby, including miscarriage, premature birth and complications during labour. Evidence from clinical trials shows that pregnancy-specific HCL systems help women maintain safer glucose levels throughout pregnancy.

The draft guidance recommends that HCL systems should be discussed with women with type 1 diabetes as soon as their diabetes or antenatal care team becomes aware of the planned or ongoing pregnancy. Training and support should be provided by specialist multidisciplinary teams and tailored to the woman’s needs and preferences.

The proposal builds on previous NICE recommendations by specifying that HCL systems used during pregnancy must have pregnancy-specific functionality to support glucose management during a period when insulin requirements change significantly and be licensed for this use.

Women can remain on their HCL system during labour and birth where this has been agreed beforehand and is considered safe. They should also be offered the choice to continue using a pregnancy-specific system for at least 6 months after childbirth. Clinicians are also advised to revisit the option with women who initially decline, as needs and preferences may change during pregnancy.

If accepted, the draft recommendations will be incorporated into an update of the NICE guideline on diabetes in pregnancy (NG3) and will align with NHS England’s 5-year plan for rolling out HCL systems for type 1 diabetes. The draft guidelines can be read here.