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

Primary Purpose

Diabetes

Status

Active

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Automated closed-loop insulin delivery (AiD)

A standard insulin delivery system

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Type 1 Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Non-type 1 diabetes.
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.
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.
Known or suspected allergy against insulin.
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.
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.
Total daily insulin dose 1.5 IU/kg.
Severe visual or hearing impairment.
Unable to speak and understand English.

Sites / Locations

Norfolk and Norwich University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

An Automated Closed-loop Insulin Delivery (AiD) System.

A Standard Insulin Delivery System

Arm Description

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.

This can include either: an insulin pump (Continuous Subcutaneous Insulin Infusion - CSII) or multiple daily injections (MDI) without closed-loop.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

CGM glucose index (Low)

The Low Blood Glucose Index (LBGI)

CGM glucose index (High)

High Blood Glucose Index (HBGI) measures

HbA1c testing (Maternal)

To assess the change of HbA1c in the maternal level.

Diabetic ketoacidosis.

The frequency and severity of diabetic ketoacidosis

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.

The number and severity of episodes of adverse device effect.

Adverse events including pregnancy loss, stillbirth, neonatal death

Hospital length of stay (maternal).

Hospital length of stay (all admissions including the delivery admission)

Mode of delivery

How the infant is delivered, for example: vaginal, instrumental, elective caesarean section and emergency caesarean section)

Gestational age at delivery

The gestational age at delivery and indication for any preterm delivery (<37 weeks). Measured in years.

Infant birth weight (LGA)

Infant birth weight (customised birth weight percentile, incidence of large for gestational age (LGA).

Infant birth weight (SGA).

Infant birth weight (customised birth weight percentile, incidence of small for gestational age (SGA).

Neonatal morbidity (hypoglycaemia, jaundice, respiratory distress).

Neonatal morbidity including treatment for neonatal hypoglycaemia, neonatal jaundice and respiratory distress.

Neonatal intensive care unit (NICU) admission.

Neonatal intensive care unit (NICU) admission >24 hours

Hospital length of stay (infant).

Hospital length of stay for the infant

Full Information

NCT ID

NCT04938557

First Posted

May 18, 2021

Last Updated

November 4, 2022

Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

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

1. Study Identification

Unique Protocol Identification Number

NCT04938557

Brief Title

Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes

Acronym

AiDAPT

Official Title

Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 26, 2019 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes

Keywords

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

An Automated Closed-loop Insulin Delivery (AiD) System.

Arm Type

Experimental

Arm Description

Arm Title

A Standard Insulin Delivery System

Arm Type

Active Comparator

Arm Description

This can include either: an insulin pump (Continuous Subcutaneous Insulin Infusion - CSII) or multiple daily injections (MDI) without closed-loop.

Intervention Type

Device

Intervention Name(s)

Automated closed-loop insulin delivery (AiD)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

A standard insulin delivery system

Intervention Description

Self-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

Between 16 weeks gestation and delivery - an average of 18 weeks

Secondary Outcome Measure Information:

Title

CGM glucose measures

Description

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

Title

CGM glucose index (Low)

Description

The Low Blood Glucose Index (LBGI)

Time Frame

Between 16 weeks gestation and delivery - an average of 18 weeks

Title

CGM glucose index (High)

Description

High Blood Glucose Index (HBGI) measures

Time Frame

Between 16 weeks gestation and delivery - an average of 18 weeks

Title

HbA1c testing (Maternal)

Description

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

Title

Diabetic ketoacidosis.

Description

The frequency and severity of diabetic ketoacidosis

Time Frame

An average of 24 weeks

Title

Severe hypoglycaemia episodes.

Description

Time Frame

An average of 24 weeks

Title

The number and severity of episodes of adverse device effect.

Description

Adverse events including pregnancy loss, stillbirth, neonatal death

Time Frame

<24 weeks gestation until delivery - an average of 16 weeks

Title

Hospital length of stay (maternal).

Description

Hospital length of stay (all admissions including the delivery admission)

Time Frame

Between 13 and 40 weeks - an average of 24 weeks

Title

Mode of delivery

Description

How the infant is delivered, for example: vaginal, instrumental, elective caesarean section and emergency caesarean section)

Time Frame

At >34 weeks (delivery)

Title

Gestational age at delivery

Description

The gestational age at delivery and indication for any preterm delivery (<37 weeks). Measured in years.

Time Frame

At >34 weeks (delivery)

Title

Infant birth weight (LGA)

Description

Infant birth weight (customised birth weight percentile, incidence of large for gestational age (LGA).

Time Frame

At >34 weeks (delivery)

Title

Infant birth weight (SGA).

Description

Infant birth weight (customised birth weight percentile, incidence of small for gestational age (SGA).

Time Frame

At >34 weeks (delivery)

Title

Neonatal morbidity (hypoglycaemia, jaundice, respiratory distress).

Description

Neonatal morbidity including treatment for neonatal hypoglycaemia, neonatal jaundice and respiratory distress.

Time Frame

Between delivery and 40 weeks - an average of 6 weeks

Title

Neonatal intensive care unit (NICU) admission.

Description

Neonatal intensive care unit (NICU) admission >24 hours

Time Frame

NICU admission after 24 hours

Title

Hospital length of stay (infant).

Description

Hospital length of stay for the infant

Time Frame

Between delivery and 40 weeks - an average of 6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Between 18 and 45 years of age (inclusive). A diagnosis of type 1 diabetes (T1D), as defined by WHO for at least 12 months. A viable pregnancy confirmed by ultrasound, up to 13 weeks and 6 days gestation. Currently on intensive insulin therapy (≥3 injections or CSII). Willingness to use the study devices throughout the trial. HbA1c level ≥48 mmol/mol (≥6.5%) at booking (first antenatal contact) and ≤86 mmol/mol (≤10%) at point of randomization. Able to provide informed consent. Have access to email. Exclusion Criteria: Non-type 1 diabetes. 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. 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. Known or suspected allergy against insulin. 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. 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. Total daily insulin dose 1.5 IU/kg. Severe visual or hearing impairment. Unable to speak and understand English.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helen Murphy

Organizational Affiliation

University of East Anglia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Norfolk and Norwich University Hospitals NHS Foundation Trust

City

Norwich

State/Province

Norfolk

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

12. IPD Sharing Statement

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Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes

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