Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes
NCT ID: NCT04938557
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
124 participants
INTERVENTIONAL
2019-09-26
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
A standard insulin delivery system
Self-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
A standard insulin delivery system
Self-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of East Anglia
OTHER
University of Cambridge
OTHER
University of Leeds
OTHER
University of Edinburgh
OTHER
University of Glasgow
OTHER
King's College London
OTHER
Belfast Health and Social Care Trust
OTHER
Norfolk and Norwich University Hospitals NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Helen Murphy
Role: PRINCIPAL_INVESTIGATOR
University of East Anglia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
240380
Identifier Type: -
Identifier Source: org_study_id