Clinical trial NCT04938557: Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes
Official title: Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Type 1 Diabetes
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of East Anglia
name: University of Cambridge
name: University of Leeds
name: University of Edinburgh
name: University of Glasgow
name: King's College London
name: Belfast Health and Social Care Trust
First posted: 2021-06-24
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open-label, multi-centre, randomized, two-arm parallel group trial
Primary purpose: TREATMENT

Brief summary: Evaluation of the biomedical and psychosocial impact of automated Closed-Loop (Artificial Pancreas) insulin delivery in women with type 1 diabetes during pregnancy

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Between 18 and 45 years of age (inclusive).
2. A diagnosis of type 1 diabetes (T1D), as defined by WHO for at least 12 months.
3. A viable pregnancy confirmed by ultrasound, up to 13 weeks and 6 days gestation.
4. Currently on intensive insulin therapy (≥3 injections or CSII).
5. Willingness to use the study devices throughout the trial.
6. HbA1c level ≥48 mmol/mol (≥6.5%) at booking (first antenatal contact) and ≤86 mmol/mol (≤10%) at point of randomization.
7. Able to provide informed consent.
8. Have access to email.

Exclusion Criteria:

1. Non-type 1 diabetes.
2. Any other physical or psychological disease which, in the opinion of the investigator, is likely to interfere with the normal conduct and interpretation of the study results e.g. untreated coeliac disease or untreated hypothyroidism.
3. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids, non-selective beta-blockers and MAO inhibitors.
4. Known or suspected allergy against insulin.
5. Women with advanced nephropathy (eGFR \<45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results.
6. Very good or very poor glycaemic control i.e. first antenatal HbA1c \<48 mmol/mol (\<6.5%) and current HbA1c \>10% (\>86 mmol/mol). Women who enter pregnancy with HbA1c \>10% (\>86 mmol/mol) may participate if they achieve HbA1c ≤10% (≤86 mmol/mol) before randomization.
7. Total daily insulin dose 1.5 IU/kg.
8. Severe visual or hearing impairment.
9. Unable to speak and understand English.

Primary outcomes:
measure: 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)
timeFrame: Between 16 weeks gestation and delivery - an average of 18 weeks
Secondary outcomes:
measure: CGM glucose measures
timeFrame: Between 16 weeks gestation and delivery - an average of 18 weeks
measure: CGM glucose index (Low)
timeFrame: Between 16 weeks gestation and delivery - an average of 18 weeks
measure: CGM glucose index (High)
timeFrame: Between 16 weeks gestation and delivery - an average of 18 weeks
measure: HbA1c testing (Maternal)
timeFrame: Blood samples will be collected at baseline, 24-26 weeks, 34-36 weeks
measure: Diabetic ketoacidosis.
timeFrame: An average of 24 weeks
measure: Severe hypoglycaemia episodes.
timeFrame: An average of 24 weeks
measure: The number and severity of episodes of adverse device effect.
timeFrame: <24 weeks gestation until delivery - an average of 16 weeks
measure: Hospital length of stay (maternal).
timeFrame: Between 13 and 40 weeks - an average of 24 weeks
measure: Mode of delivery
timeFrame: At >34 weeks (delivery)
measure: Gestational age at delivery
timeFrame: At >34 weeks (delivery)
measure: Infant birth weight (LGA)
timeFrame: At >34 weeks (delivery)
measure: Infant birth weight (SGA).
timeFrame: At >34 weeks (delivery)
measure: Neonatal morbidity (hypoglycaemia, jaundice, respiratory distress).
timeFrame: Between delivery and 40 weeks - an average of 6 weeks
measure: Neonatal intensive care unit (NICU) admission.
timeFrame: NICU admission after 24 hours
measure: Hospital length of stay (infant).
timeFrame: Between delivery and 40 weeks - an average of 6 weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
Study officials:
affiliation: University of East Anglia
name: Helen Murphy
role: PRINCIPAL_INVESTIGATOR
References: