Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000508471
Ethics application status
Approved
Date submitted
28/04/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determining the accuracy of continuous glucose monitoring during periods of acute glycaemic variability in pregnancy
Scientific title
Determining the accuracy of continuous glucose monitoring during periods of acute glycaemic variability in pregnancy (during hospital admission or during labour with or without betamethasone infusion).
Secondary ID [1] 314305 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes in pregnancy 337254 0
Condition category
Condition code
Reproductive Health and Childbirth 333744 333744 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 333658 333658 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to assess the accuracy of continuous glucose monitoring (CGM) during periods of acute glycaemic variability in pregnancy, such as during hospital admission for acute illness or labour with or without betamethasone infusion.

During hospitalisation, blood glucose monitoring will follow standard hospital protocols, which rely exclusively on capillary blood glucose measurements. While pregnant women often continue wearing their personal CGM devices during hospital stays, particularly those already using them as outpatients, CGM data will not be used to guide clinical decisions. All inpatient diabetes management, including insulin dosing, will be based solely on capillary blood glucose readings, in accordance with current standards of care. Participants were informed of this and encouraged to continue wearing their CGM devices during hospitalisation to support study data collection. Blood glucose checks will typically be performed 5–6 times daily for patients on multiple daily insulin injections (MDI), and hourly for those on intravenous insulin infusions, with increased frequency (every 30 minutes) if glucose levels fall outside target ranges. Some participants may receive betamethasone infusion during their hospital stay, independent of study involvement. Importantly, no study-related glucose monitoring will occur at home following discharge after birth.
Intervention code [1] 330919 0
Not applicable
Comparator / control treatment
In the same participant group, blood glucose monitoring during hospitalisation will follow standard hospital protocols and serve as the reference (control) for the study. For research purposes and in the same participant group, capillary blood glucose readings will be compared with the corresponding CGM readings taken within 7 minutes of each capillary measurement to assess the accuracy of CGM devices. This comparison will not influence clinical management, as all treatment decisions will continue to rely solely on capillary blood glucose values in accordance with current standards of care.
Control group
Active

Outcomes
Primary outcome [1] 341248 0
2. Mean Absolute Relative Difference (MARD) < 12.0%
Timepoint [1] 341248 0
At a single timepoint following discharge home post delivery
Primary outcome [2] 341247 0
1. The proportion of contiguous glucose monitoring (CGM) values that comply with FDA integrated contiguous glucose monitoring accuracy requirements.
Timepoint [2] 341247 0
At a single timepoint following discharge home post delivery
Secondary outcome [1] 446904 0
• To determine the delay between capillary blood glucose and sensor glucose during hypoglycaemia <3.5mmol/L
Timepoint [1] 446904 0
At a single timepoint following discharge home post delivery. The CGM gives frequent reading every 5 minutes or every 15 minutes. The same capillary blood glucose reading will be compared with multiple CGM readings in this scenario. Again all of these comparisons will be done at a single timepoint following discharge home post delivery.

Eligibility
Key inclusion criteria
1. Pregnant women at the age of 18 years old or more with T1 DM who attended the antenatal clinic at John Hunter Hospital and used their own CGM or were enrolled for CGM.
2. pregnant women at the age of 18 years old or more with T2 DM mellitus who attended the antenatal clinic at John Hunter Hospital and used their own CGM or were enrolled for CGM,
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant women with DM who were unable to wear CGM due to an allergy or other medical condition.
2. Pregnant women with DM who declined or were unable to give consent, despite use of an interpreter where required.
3. Pregnant women with regular paracetamol intake, as paracetamol could affect the CGM accuracy.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/11/2021
Date of last participant enrolment
Anticipated
Actual
9/08/2023
Date of last data collection
Anticipated
Actual
21/03/2025
Sample size
Target
40
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318827 0
Charities/Societies/Foundations
Name [1] 318827 0
This study was awarded a John Hunter Hospital Charitable Trust Grant to cover consumables and statistical support
Country [1] 318827 0
Australia
Funding source category [2] 318941 0
University
Name [2] 318941 0
This research was supported by an Australian Government Research Training Program (RTP) Scholarship - University of Newcastle
Country [2] 318941 0
Australia
Primary sponsor type
Individual
Name
Naeel Mohammad - John Hunter Hospital and The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 321274 0
Individual
Name [1] 321274 0
Professor Katie Wynne - John Hunter Hospital and The University of Newcastle
Address [1] 321274 0
Country [1] 321274 0
Australia
Secondary sponsor category [2] 321275 0
Individual
Name [2] 321275 0
Dr. Christopher Rowe - John Hunter Hospital and The University of Newcastle
Address [2] 321275 0
Country [2] 321275 0
Australia
Other collaborator category [1] 283505 0
University
Name [1] 283505 0
The University of Newcastle
Address [1] 283505 0
Country [1] 283505 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317443 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 317443 0
Ethics committee country [1] 317443 0
Australia
Date submitted for ethics approval [1] 317443 0
30/06/2021
Approval date [1] 317443 0
18/08/2021
Ethics approval number [1] 317443 0
2021/ETH01402

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141046 0
Dr Naeel Mohammad
Address 141046 0
The University of Newcastle, University Drive, Callaghan NSW 2308
Country 141046 0
Australia
Phone 141046 0
+61 450244987
Fax 141046 0
Email 141046 0
[email protected]
Contact person for public queries
Name 141047 0
Naeel Mohammad
Address 141047 0
The University of Newcastle, University Drive, Callaghan NSW 2308
Country 141047 0
Australia
Phone 141047 0
+61 450244987
Fax 141047 0
Email 141047 0
[email protected]
Contact person for scientific queries
Name 141048 0
Naeel Mohammad
Address 141048 0
The University of Newcastle, University Drive, Callaghan NSW 2308
Country 141048 0
Australia
Phone 141048 0
+61 450244987
Fax 141048 0
Email 141048 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Ethical Approval.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.