Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT)

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Automated closed-loop insulin delivery (AiD); Device: A standard insulin delivery system

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: An Automated Closed-loop Insulin Delivery (AiD) System.; The intervention being evaluated in this trial is automated closed-loop insulin delivery (AiD). The closed-loop system comprises of three components: an insulin pump, a continuous glucose monitor (CGM) and a computer-based model predictive control (MPC) algorithm to compute information from the CGM into a recommended insulin dose.	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.
Active Comparator: A Standard Insulin Delivery System; This can include either: an insulin pump (Continuous Subcutaneous Insulin Infusion - CSII) or multiple daily injections (MDI) without closed-loop.	Device: A standard insulin delivery system; Self-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
CGM glucose index (Low)	The Low Blood Glucose Index (LBGI)	Between 16 weeks gestation and delivery - an average of 18 weeks
CGM glucose index (High)	High Blood Glucose Index (HBGI) measures	Between 16 weeks gestation and delivery - an average of 18 weeks
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
Diabetic ketoacidosis.	The frequency and severity of diabetic ketoacidosis	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.	An average of 24 weeks
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
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
Mode of delivery	How the infant is delivered, for example: vaginal, instrumental, elective caesarean section and emergency caesarean section)	At >34 weeks (delivery)
Gestational age at delivery	The gestational age at delivery and indication for any preterm delivery (<37 weeks). Measured in years.	At >34 weeks (delivery)
Infant birth weight (LGA)	Infant birth weight (customised birth weight percentile, incidence of large for gestational age (LGA).	At >34 weeks (delivery)
Infant birth weight (SGA).	Infant birth weight (customised birth weight percentile, incidence of small for gestational age (SGA).	At >34 weeks (delivery)
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
Neonatal intensive care unit (NICU) admission.	Neonatal intensive care unit (NICU) admission >24 hours	NICU admission after 24 hours
Hospital length of stay (infant).	Hospital length of stay for the infant	Between delivery and 40 weeks - an average of 6 weeks

Collaborators and Investigators

• Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Collaborators: King's College London; University of Leeds; Belfast Health and Social Care Trust; University of Edinburgh; University of East Anglia; University of Cambridge; University of Glasgow
• Investigators: Principal Investigator: Helen Murphy, University of East Anglia

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Type 1 Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 240380

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No