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

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ClinicalTrials.gov Identifier: NCT04938557
Recruitment Status : Completed
First Posted : June 24, 2021
Last Update Posted : December 18, 2023
Sponsor:
Collaborators:
University of East Anglia
University of Cambridge
University of Leeds
University of Edinburgh
University of Glasgow
King's College London
Belfast Health and Social Care Trust
Information provided by (Responsible Party):
Norfolk and Norwich University Hospitals NHS Foundation Trust

Study Description
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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

Condition or disease Intervention/treatment Phase
Diabetes Device: Automated closed-loop insulin delivery (AiD) Device: A standard insulin delivery system Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An open-label, multi-centre, randomized, two-arm parallel group trial
Masking: None (Open Label)
Masking Description: This is an unblinded trial. Both participants and their clinical care team will be aware of the allocation.
Primary Purpose: Treatment
Official Title: Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes
Actual Study Start Date : September 26, 2019
Actual Primary Completion Date : April 30, 2022
Actual Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: Between 16 weeks gestation and delivery - an average of 18 weeks ]
    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.


Secondary Outcome Measures :
  1. CGM glucose measures [ Time Frame: Between 16 weeks gestation and delivery - an average of 18 weeks ]
    The time spent with CGM glucose levels above and below target range, using the mean CGM glucose and CGM glucose variability measures (CV, SD).

  2. CGM glucose index (Low) [ Time Frame: Between 16 weeks gestation and delivery - an average of 18 weeks ]
    The Low Blood Glucose Index (LBGI)

  3. CGM glucose index (High) [ Time Frame: Between 16 weeks gestation and delivery - an average of 18 weeks ]
    High Blood Glucose Index (HBGI) measures

  4. HbA1c testing (Maternal) [ Time Frame: Blood samples will be collected at baseline, 24-26 weeks, 34-36 weeks ]
    To assess the change of HbA1c in the maternal level.

  5. Diabetic ketoacidosis. [ Time Frame: An average of 24 weeks ]
    The frequency and severity of diabetic ketoacidosis

  6. Severe hypoglycaemia episodes. [ Time Frame: An average of 24 weeks ]
    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.

  7. The number and severity of episodes of adverse device effect. [ Time Frame: <24 weeks gestation until delivery - an average of 16 weeks ]
    Adverse events including pregnancy loss, stillbirth, neonatal death

  8. Hospital length of stay (maternal). [ Time Frame: Between 13 and 40 weeks - an average of 24 weeks ]
    Hospital length of stay (all admissions including the delivery admission)

  9. Mode of delivery [ Time Frame: At >34 weeks (delivery) ]
    How the infant is delivered, for example: vaginal, instrumental, elective caesarean section and emergency caesarean section)

  10. Gestational age at delivery [ Time Frame: At >34 weeks (delivery) ]
    The gestational age at delivery and indication for any preterm delivery (<37 weeks). Measured in years.

  11. Infant birth weight (LGA) [ Time Frame: At >34 weeks (delivery) ]
    Infant birth weight (customised birth weight percentile, incidence of large for gestational age (LGA).

  12. Infant birth weight (SGA). [ Time Frame: At >34 weeks (delivery) ]
    Infant birth weight (customised birth weight percentile, incidence of small for gestational age (SGA).

  13. Neonatal morbidity (hypoglycaemia, jaundice, respiratory distress). [ Time Frame: Between delivery and 40 weeks - an average of 6 weeks ]
    Neonatal morbidity including treatment for neonatal hypoglycaemia, neonatal jaundice and respiratory distress.

  14. Neonatal intensive care unit (NICU) admission. [ Time Frame: NICU admission after 24 hours ]
    Neonatal intensive care unit (NICU) admission >24 hours

  15. Hospital length of stay (infant). [ Time Frame: Between delivery and 40 weeks - an average of 6 weeks ]
    Hospital length of stay for the infant


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04938557


Locations
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United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
Sponsors and Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
University of East Anglia
University of Cambridge
University of Leeds
University of Edinburgh
University of Glasgow
King's College London
Belfast Health and Social Care Trust
Investigators
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Principal Investigator: Helen Murphy University of East Anglia
More Information
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Responsible Party: Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04938557    
Other Study ID Numbers: 240380
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: December 18, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norfolk and Norwich University Hospitals NHS Foundation Trust:
Type 1 Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs