NCT04938557

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

2.6 years

First QC Date

May 18, 2021

Last Update Submit

December 15, 2023

Conditions

Diabetes

Keywords

Type 1 Diabetes

Outcome Measures

Primary Outcomes (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)

    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 Outcomes (15)

  • CGM glucose measures

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

  • CGM glucose index (Low)

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

  • CGM glucose index (High)

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

  • HbA1c testing (Maternal)

    Blood samples will be collected at baseline, 24-26 weeks, 34-36 weeks

  • Diabetic ketoacidosis.

    An average of 24 weeks

  • +10 more secondary outcomes

Study Arms (2)

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.

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.

Device: A standard insulin delivery system

Interventions

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.

An Automated Closed-loop Insulin Delivery (AiD) System.
A standard insulin delivery systemDEVICE

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

A Standard Insulin Delivery System

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 37795883DERIVED

  • 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.

    PMID: 36662589DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Helen Murphy

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an unblinded trial. Both participants and their clinical care team will be aware of the allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: An open-label, multi-centre, randomized, two-arm parallel group trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

June 24, 2021

Study Start

September 26, 2019

Primary Completion

April 30, 2022

Study Completion

June 30, 2023

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations

GB(1)