Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes

Diabetes Clinical Trial

— AiDAPT  

Official title:

Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04938557
• Other study ID #: 240380
• Status: Completed
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Automated closed-loop insulin delivery (AiD)
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.
• A standard insulin delivery system
Self-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk

Sponsors (8)

Lead Sponsor	Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust	Belfast Health and Social Care Trust, King's College London, University of Cambridge, University of East Anglia, University of Edinburgh, University of Glasgow, University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Between 16 weeks gestation and delivery - an average of 18 weeks
Secondary	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).	Between 16 weeks gestation and delivery - an average of 18 weeks
Secondary	CGM glucose index (Low)	The Low Blood Glucose Index (LBGI)	Between 16 weeks gestation and delivery - an average of 18 weeks
Secondary	CGM glucose index (High)	High Blood Glucose Index (HBGI) measures	Between 16 weeks gestation and delivery - an average of 18 weeks
Secondary	HbA1c testing (Maternal)	To assess the change of HbA1c in the maternal level.	Blood samples will be collected at baseline, 24-26 weeks, 34-36 weeks
Secondary	Diabetic ketoacidosis.	The frequency and severity of diabetic ketoacidosis	An average of 24 weeks
Secondary	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.	An average of 24 weeks
Secondary	The number and severity of episodes of adverse device effect.	Adverse events including pregnancy loss, stillbirth, neonatal death	<24 weeks gestation until delivery - an average of 16 weeks
Secondary	Hospital length of stay (maternal).	Hospital length of stay (all admissions including the delivery admission)	Between 13 and 40 weeks - an average of 24 weeks
Secondary	Mode of delivery	How the infant is delivered, for example: vaginal, instrumental, elective caesarean section and emergency caesarean section)	At >34 weeks (delivery)
Secondary	Gestational age at delivery	The gestational age at delivery and indication for any preterm delivery (<37 weeks). Measured in years.	At >34 weeks (delivery)
Secondary	Infant birth weight (LGA)	Infant birth weight (customised birth weight percentile, incidence of large for gestational age (LGA).	At >34 weeks (delivery)
Secondary	Infant birth weight (SGA).	Infant birth weight (customised birth weight percentile, incidence of small for gestational age (SGA).	At >34 weeks (delivery)
Secondary	Neonatal morbidity (hypoglycaemia, jaundice, respiratory distress).	Neonatal morbidity including treatment for neonatal hypoglycaemia, neonatal jaundice and respiratory distress.	Between delivery and 40 weeks - an average of 6 weeks
Secondary	Neonatal intensive care unit (NICU) admission.	Neonatal intensive care unit (NICU) admission >24 hours	NICU admission after 24 hours
Secondary	Hospital length of stay (infant).	Hospital length of stay for the infant	Between delivery and 40 weeks - an average of 6 weeks