DiabetesAiDAPTNCT04938557

Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes

A study testing Automated closed-loop insulin delivery (AiD) and A standard insulin delivery system in people with Diabetes, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Diabetes
What is being tested?: Automated closed-loop insulin delivery (AiD) and A standard insulin delivery system
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 1 siteUnited Kingdom
Study dates: 26 Sep 2019to 30 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

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Total daily insulin dose 1.5 IU/kg.
Severe visual or hearing impairment.
Unable to speak and understand English.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

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

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions: Diabetes
Being tested: Automated closed-loop insulin delivery (AiD), A standard insulin delivery system
Keywords: Type 1 Diabetes
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04938557
Study group	Role	What they receive
An Automated Closed-loop Insulin Delivery (AiD) System.	Experimental	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. Receives: Device: Automated closed-loop insulin delivery (AiD)
A Standard Insulin Delivery System	Active comparator	This can include either: an insulin pump (Continuous Subcutaneous Insulin Infusion - CSII) or multiple daily injections (MDI) without closed-loop. Receives: Device: A standard insulin delivery system

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Between 16 weeks gestation and delivery - an average of 18 weeks

Secondary outcomes (15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 201930 Jun 2023

First posted24 Jun 2021
Study start26 Sep 2019
Primary completion30 Apr 2022
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: An open-label, multi-centre, randomized, two-arm parallel group trial
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04938557
Sponsor's protocol ID: 240380
Acronym: AiDAPT
Status last verified: Dec 2023
First submitted: 18 May 2021
Last updated: 18 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lawton J, Kimbell B, Closs M, Hartnell S, Lee TTM, Dover AR, Reynolds RM, Collett C, Barnard-Kelly K, Hovorka R, Rankin D, Murphy HR. Listening to Women: Experiences of Using Closed-Loop in Type 1 Diabetes Pregnancy. Diabetes Technol Ther. 2023 Dec;25(12):845-855. doi: 10.1089/dia.2023.0323. Epub 2023 Nov 7.
PubMed 37795883
Rankin D, Hart RI, Kimbell B, Barnard-Kelly K, Brackenridge A, Byrne C, Collett C, Dover AR, Hartnell S, Hunt KF, Lee TTM, Lindsay RS, McCance DR, McKelvey A, Rayman G, Reynolds RM, Scott EM, White SL, Hovorka R, Murphy HR, Lawton J. Rollout of Closed-Loop Technology to Pregnant Women with Type 1 Diabetes: Healthcare Professionals' Views About Potential Challenges and Solutions. Diabetes Technol Ther. 2023 Apr;25(4):260-269. doi: 10.1089/dia.2022.0479. Epub 2023 Feb 27.
PubMed 36662589

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes
ClinicalTrials.gov ID: NCT04938557
Acronym / sponsor ID: AiDAPT / 240380
Conditions: Diabetes
Keywords: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
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
Study start: 26 Sep 2019 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 24 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: An open-label, multi-centre, randomized, two-arm parallel group trial

Arm	Type	Receives
An Automated Closed-loop Insulin Delivery (AiD) System.	Experimental	Device: Automated closed-loop insulin delivery (AiD)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.
A Standard Insulin Delivery System	Active comparator	Device: A standard insulin delivery systemThis can include either: an insulin pump (Continuous Subcutaneous Insulin Infusion - CSII) or multiple daily injections (MDI) without closed-loop.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	An Automated Closed-loop Insulin Delivery (AiD) System.
A standard insulin delivery systemSelf-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.	Device	A Standard Insulin Delivery System

Primary outcome

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.

15 secondary outcomes

CGM glucose measures
Time frame: Between 16 weeks gestation and delivery - an average of 18 weeks
CGM glucose index (Low)
Time frame: Between 16 weeks gestation and delivery - an average of 18 weeks
CGM glucose index (High)
Time frame: Between 16 weeks gestation and delivery - an average of 18 weeks
HbA1c testing (Maternal)
Time frame: Blood samples will be collected at baseline, 24-26 weeks, 34-36 weeks
Diabetic ketoacidosis.
Time frame: An average of 24 weeks
Severe hypoglycaemia episodes.
Time frame: An average of 24 weeks
The number and severity of episodes of adverse device effect.
Time frame: <24 weeks gestation until delivery - an average of 16 weeks
Hospital length of stay (maternal).
Time frame: Between 13 and 40 weeks - an average of 24 weeks
Mode of delivery
Time frame: At >34 weeks (delivery)
Gestational age at delivery
Time frame: At >34 weeks (delivery)
Infant birth weight (LGA)
Time frame: At >34 weeks (delivery)
Infant birth weight (SGA).
Time frame: At >34 weeks (delivery)
Neonatal morbidity (hypoglycaemia, jaundice, respiratory distress).
Time frame: Between delivery and 40 weeks - an average of 6 weeks
Neonatal intensive care unit (NICU) admission.
Time frame: NICU admission after 24 hours
Hospital length of stay (infant).
Time frame: Between delivery and 40 weeks - an average of 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Derived from this study: PubMed 37795883Lawton J, Kimbell B, Closs M, Hartnell S, Lee TTM, Dover AR, Reynolds RM, Collett C, Barnard-Kelly K, Hovorka R, Rankin D, Murphy HR. Listening to Women: Experiences of Using Closed-Loop in Type 1 Diabetes Pregnancy. Diabetes Technol Ther. 2023 Dec;25(12):845-855. doi: 10.1089/dia.2023.0323. Epub 2023 Nov 7.
Derived from this study: PubMed 36662589Rankin D, Hart RI, Kimbell B, Barnard-Kelly K, Brackenridge A, Byrne C, Collett C, Dover AR, Hartnell S, Hunt KF, Lee TTM, Lindsay RS, McCance DR, McKelvey A, Rayman G, Reynolds RM, Scott EM, White SL, Hovorka R, Murphy HR, Lawton J. Rollout of Closed-Loop Technology to Pregnant Women with Type 1 Diabetes: Healthcare Professionals' Views About Potential Challenges and Solutions. Diabetes Technol Ther. 2023 Apr;25(4):260-269. doi: 10.1089/dia.2022.0479. Epub 2023 Feb 27.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helen Murphy principal investigator

University of East Anglia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Between 16 weeks gestation and delivery - an average of 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04938557, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.