Evaluation of the biomedical and psychosocial impact of automated Closed-Loop (Artificial Pancreas) insulin delivery in women with type 1 diabetes during pregnancy
An open-label, multi-centre, randomized, two-arm parallel group trial comparing automated closed-loop and standard insulin delivery. 124 pregnant women between 18 and 45 years of age with Type 1 Diabetes of at least 12 months' duration on standard insulin delivery (CSII or MDI) will be recruited through outpatient antenatal diabetes clinics. Women fulfilling the eligibility criteria will be randomized to automated insulin delivery (AiD) or to continue standard patient-directed insulin delivery (CSII or MDI) without AiD. The study will take place within the home and NHS antenatal clinical settings. Additional blood samples for the research will be obtained at the 24th and 34th week of pregnancy and questionnaires will also be completed by the participant at the 34th week of pregnancy. Following this we will collect information on the birth. 25 of the woman randomised to the closed loop insulin delivery system will also be interviewed to gain more information on, among other things, their existing diabetes management practices, everyday work and family lives and their experience with the device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Closed-loop systems are designed to deliver insulin in response to CGM glucose levels and may help to improve glucose control above and beyond what is currently achievable using insulin pumps, injections and CGM without AiD.
Self-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom
The time spent with glucose levels between 3.5-7.8 mmol/L based on CGM measures (Time In Range TIR 3.5-7.8mmol/L)
The primary outcome is the percentage of time spent with glucose levels between 3.9-7.8 mmol/L based on CGM levels between 16 weeks gestation and delivery.as compared with standard self-directed insulin delivery in pregnant women with T1D.
Time frame: Between 16 weeks gestation and delivery - an average of 18 weeks
CGM glucose measures
The time spent with CGM glucose levels above and below target range, using the mean CGM glucose and CGM glucose variability measures (CV, SD).
Time frame: Between 16 weeks gestation and delivery - an average of 18 weeks
CGM glucose index (Low)
The Low Blood Glucose Index (LBGI)
Time frame: Between 16 weeks gestation and delivery - an average of 18 weeks
CGM glucose index (High)
High Blood Glucose Index (HBGI) measures
Time frame: Between 16 weeks gestation and delivery - an average of 18 weeks
HbA1c testing (Maternal)
To assess the change of HbA1c in the maternal level.
Time frame: Blood samples will be collected at baseline, 24-26 weeks, 34-36 weeks
Diabetic ketoacidosis.
The frequency and severity of diabetic ketoacidosis
Time frame: An average of 24 weeks
Severe hypoglycaemia episodes.
The frequency and severity of hypoglycaemia episodes defined as CGM glucose levels \<3.5 mmol/L (level 1 hypoglycaemia) and \<2.8 mmol/L (level 2 hypoglycaemia) for at least 15 minutes. Distinct episodes must be separated for at least 30 minutes.
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Time frame: An average of 24 weeks
The number and severity of episodes of adverse device effect.
Adverse events including pregnancy loss, stillbirth, neonatal death
Time frame: <24 weeks gestation until delivery - an average of 16 weeks
Hospital length of stay (maternal).
Hospital length of stay (all admissions including the delivery admission)
Time frame: Between 13 and 40 weeks - an average of 24 weeks
Mode of delivery
How the infant is delivered, for example: vaginal, instrumental, elective caesarean section and emergency caesarean section)
Time frame: At >34 weeks (delivery)
Gestational age at delivery
The gestational age at delivery and indication for any preterm delivery (\<37 weeks). Measured in years.
Time frame: At >34 weeks (delivery)
Infant birth weight (LGA)
Infant birth weight (customised birth weight percentile, incidence of large for gestational age (LGA).
Time frame: At >34 weeks (delivery)
Infant birth weight (SGA).
Infant birth weight (customised birth weight percentile, incidence of small for gestational age (SGA).
Time frame: At >34 weeks (delivery)
Neonatal morbidity (hypoglycaemia, jaundice, respiratory distress).
Neonatal morbidity including treatment for neonatal hypoglycaemia, neonatal jaundice and respiratory distress.
Time frame: Between delivery and 40 weeks - an average of 6 weeks
Neonatal intensive care unit (NICU) admission.
Neonatal intensive care unit (NICU) admission \>24 hours
Time frame: NICU admission after 24 hours
Hospital length of stay (infant).
Hospital length of stay for the infant
Time frame: Between delivery and 40 weeks - an average of 6 weeks