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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes in pregnancy

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

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]

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]

1. The proportion of contiguous glucose monitoring (CGM) values that comply with FDA integrated contiguous glucose monitoring accuracy requirements.

Timepoint [1]

At a single timepoint following discharge home post delivery

Primary outcome [2]

2. Mean Absolute Relative Difference (MARD) < 12.0%

Timepoint [2]

At a single timepoint following discharge home post delivery

Secondary outcome [1]

• To determine the delay between capillary blood glucose and sensor glucose during hypoglycaemia <3.5mmol/L

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

This study was awarded a John Hunter Hospital Charitable Trust Grant to cover consumables and statistical support

Address [1]

Country [1]

Australia

Funding source category [2]

University

Name [2]

This research was supported by an Australian Government Research Training Program (RTP) Scholarship - University of Newcastle

Address [2]

Country [2]

Australia

Primary sponsor type

Individual

Name

Naeel Mohammad - John Hunter Hospital and The University of Newcastle

Address

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Katie Wynne - John Hunter Hospital and The University of Newcastle

Address [1]

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr. Christopher Rowe - John Hunter Hospital and The University of Newcastle

Address [2]

Country [2]

Australia

Other collaborator category [1]

University

Name [1]

The University of Newcastle

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

https://www.hnehealth.nsw.gov.au/research-office/research_ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/06/2021

Approval date [1]

18/08/2021

Ethics approval number [1]

2021/ETH01402

Summary

Brief summary

Guidelines recommend continuous glucose monitoring (CGM) for all ambulatory pregnant women with Type 1 diabetes (T1 DM), and insulin-treated pregnant women with Type 2 diabetes (T2 DM) and hypoglycaemic risk. However, evidence for efficacy and safety of CGM in a hospital setting is lacking.                                                                                   
Aim: To determine CGM accuracy and potential clinical risk of using CGM compared to the reference (capillary blood glucose level, capillary BG level) in pregnant women with T1 DM or T2 DM during acute hospitalisation.                                                       
Method: Prospective cohort study.  CGM glucose was compared to paired capillary BG during hospitalisation. Concordance was assessed using paired values distribution, mean absolute relative deviation (MARD), Clarke Error Grid (CEG) Analysis, and the FDA standard for new integrated Contiguous Glucose Monitoring (iCGM) accuracy.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Naeel Mohammad

Address

The University of Newcastle, University Drive, Callaghan NSW 2308

Country

Australia

Phone

+61 450244987

Fax

[email protected]

Contact person for public queries

Name

Naeel Mohammad

Address

The University of Newcastle, University Drive, Callaghan NSW 2308

Country

Australia

Phone

+61 450244987

Fax

[email protected]

Contact person for scientific queries

Name

Naeel Mohammad

Address

The University of Newcastle, University Drive, Callaghan NSW 2308

Country

Australia

Phone

+61 450244987

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24675	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.

Trial Review

Documents added manually

Documents added automatically