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Trial registered on ANZCTR

Registration number

ACTRN12625000370404

Ethics application status

Approved

Date submitted

14/02/2025

Date registered

28/04/2025

Date last updated

28/04/2025

Date data sharing statement initially provided

28/04/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Continuous Glucose monitoring for Type 2 Diabetes in Pregnancy: a Feasibility Study

Scientific title

Continuous Glucose monitoring for Type 2 Diabetes in Pregnancy: a Feasibility Study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1319-0799

Trial acronym

Linked study record

Health condition

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

Type 2 diabetes

Pregnancy

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Reproductive Health and Childbirth

Antenatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In the CGM unmasked group, participants are able to visualise glucose levels in real time using either a cell-phone app, or a receiver device (supplied by the study) when wearing the CGM.

All participants are required to wear a Dexcom One+ continuous glucose monitor (CGM), for 20 days, whilst continuing to undertake routine self-testing of capillary glucose levels throughout the study period.

Application of the device (both groups)
Each participant will be expected to apply two CGM over the course of the study (a third CGM may be required in the instance where there are sensor issues with one of the earlier CGM that require an early change over after <8 days of use). The first CGM application will be applied by the patient under the supervision of a research midwife/assistant, Subsequent CGM placement will be by the participant. If a participant desires assistance with application, they can contact a study investigator for advice via the phone.

Usual activities whilst wearing the device (both groups)
Whilst wearing the CGM, participants will go about their usual activities. There is no restriction on activities (eg swimming, bathing, exercising can be done normally).

Antenatal care whilst in the study (both groups)
Participants continue their usual schedule of antenatal care and appointments. At 34-36 weeks, this is expected (but not mandated) that this will include fortnightly followup with their usual antenatal care provider, and 4-7xs daily self testing blood glucose levels, sending these via email or text to their diabetes in pregnancy midwife.

Study contact (both groups)
There is only one in-person study encounter which takes place on the day of randomisation. At this encounter information is provided about placing the CGM and using the CGM (unmasked group only), and data is collected about baseline demographics, clinical features and diabetes distress. The CGM is placed under supervision of the research team.
Participants are then contacted by telephone 24-48 hrs after CGM placement, and again at day 11 and day 21. At these contacts the research assistant enquires as to if there have been any issues with device use, and/or removal/replacement (day 11, 21). Where a replacement CGM has been required earlier, the participant will be contacted 24-48 hrs after replacement.

Viewing of CGM results (unmasked group only)
Participants in the unmasked group have the ability of viewing their glucose levels in real time either via a receiver provided by the research team, or their smart phone using the Dexcom Clarity app. The app allows visualisation of glucose levels in real time, and provides summary statistics on glucose metrics. Use of the app or viewing results via receiver is optional. We will enquire at the exit interview as to whether participants used the app or receiver, but no formal measurement of frequency or duration of app usage or adherence will be used.
Whilst CGM data from the unmasked arm will be available for participants to view and share with their clinicians, clinical decisions will be based off self-testing results, and therefore randomisation is not anticipated to influence clinical outcomes.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Participants will be randomised 1:1 to masked (blinded) CGM use, vs unmasked CGM use.

In the CGM masked group, participants wear the cGM but cannot see any glucose values.

All participants are required to wear a Dexcom One+ continuous glucose monitor (CGM), for 20 days, whilst continuing to undertake routine self-testing of capillary glucose levels throughout the study period.

Application of the device (both groups)
Each participant will be expected to apply two CGM over the course of the study (a third CGM may be required in the instance where there are sensor issues with one of the earlier CGM that require an early change over after <8 days of use). The first CGM application will be applied by the patient under the supervision of a research midwife/assistant, Subsequent CGM placement will be by the participant. If a participant desires assistance with application, they can contact a study investigator for advice via the phone.

Usual activities whilst wearing the device (both groups)
Whilst wearing the CGM, participants will go about their usual activities. There is no restriction on activities (eg swimming, bathing, exercising can be done normally).

Antenatal care whilst in the study (both groups)
Participants continue their usual schedule of antenatal care and appointments. At 34-36 weeks, this is expected (but not mandated) that this will include fortnightly followup with their usual antenatal care provider, and 4-7xs daily self testing blood glucose levels, sending these via email or text to their diabetes in pregnancy midwife.

Study contact (both groups)
There is only one in-person study encounter which takes place on the day of randomisation. At this encounter information is provided about placing the CGM, and data is collected about baseline demographics, clinical features and diabetes distress. The CGM is placed under supervision of the research team.
Participants are then contacted by telephone 24-48 hrs after CGM placement, and again at day 11 and day 21. At these contacts the research assistant enquires as to if there have been any issues with device use, and/or removal/replacement (day 11, 21). Where a replacement CGM has been required earlier, the participant will be contacted 24-48 hrs after replacement.

Participants in the masked CGM group will have the opportunity to review their glucose readings from the time the CGM is worn at the completion of their study involvement.

Control group

Active

Outcomes

Primary outcome [1]

Recruitment

Timepoint [1]

Assessed at the recruitment period

Primary outcome [2]

Retention

Timepoint [2]

Day 21 following randomisation or at day of established labour / cesarean section (if occurs sooner)

Primary outcome [3]

Obtaining a minimum CGM dataset

Timepoint [3]

Day 21 following randomisation

Secondary outcome [1]

Reasons for declining entry.

Timepoint [1]

Baseline

Secondary outcome [2]

Reasons for non-retention or study dropout.

Timepoint [2]

Day 21 or as soon as practicable after study cessation.

Secondary outcome [3]

Completeness of data CGM data

Timepoint [3]

Day 21 or at day of established labour / cesarean section (if occurs sooner)

Secondary outcome [4]

Staff contact regarding CGM (not relating to diabetes management)

Timepoint [4]

Day 21 or at day of established labour / cesarean section (if occurs sooner)

Secondary outcome [5]

acceptability of the CGM for participants

Timepoint [5]

Day 21 or as soon as practicable after study cessation.

Secondary outcome [6]

acceptability of participation in the research study and a future masked trial

Timepoint [6]

Day 21 or as soon as practicable after study cessation.

Secondary outcome [7]

Diabetes related distress score (DDS-17)

Timepoint [7]

baseline and Day 21 (or as soon as practicable after study cessation)

Secondary outcome [8]

CGM glycaemic metrics o Time in range (3.5 – 7.8 mmol/L)

Timepoint [8]

from baseline (randomisation) until 72 hrs post randomisation, baseline until day 10 post randomisation, from baseline until day 20 post randomisation.

Secondary outcome [9]

Completeness of self-monitoring data

Timepoint [9]

From baseline until day day 21 post randomisation

Secondary outcome [10]

Completeness of questionnaire data

Timepoint [10]

baseline, day 21 (or as soon as practicable after study cessation)

Secondary outcome [11]

Maternal weight gain

Timepoint [11]

At baseline (randomisation) and within 1 week prior to giving birth

Secondary outcome [12]

Severe maternal hypoglycemia (blood glucose <2.8 mmol/L) during study period

Timepoint [12]

Throughout enrolment from baseline (randomisation) until day 21 post randomisation (or day of active labour / cesarean birth if this is sooner).

Secondary outcome [13]

Diabetic ketoacidosis during study period

Timepoint [13]

Throughout enrolment from baseline (randomisation) until day 21 post randomisation (or day of active labour / cesarean birth if this is sooner).

Secondary outcome [14]

Presence of hypertensive disorder

Timepoint [14]

Throughout enrolment from baseline (randomisation) until day 21 post randomisation (or day of active labour / cesarean birth if this is sooner).

Secondary outcome [15]

Induction of labour

Timepoint [15]

At given birth

Secondary outcome [16]

Maternal death

Timepoint [16]

Day 21, or day of active labour / cesarean birth (if this is sooner)

Secondary outcome [17]

Infant birth weight

Timepoint [17]

At given birth

Secondary outcome [18]

Gestational age at given birth

Timepoint [18]

At given birth

Secondary outcome [19]

Mode of birth

Timepoint [19]

At given birth

Secondary outcome [20]

Shoulder dystocia

Timepoint [20]

At given birth

Secondary outcome [21]

Neonatal hypoglycaemia (at least 1 BGC <2.6 mmol/L),

Timepoint [21]

48hrs of age

Secondary outcome [22]

Requirement for neonatal respiratory support

Timepoint [22]

2 weeks of age

Secondary outcome [23]

Stillbirth or early neonatal death

Timepoint [23]

7 days of age

Secondary outcome [24]

Neonatal bicep thickness

Timepoint [24]

by 72 hours of age

Secondary outcome [25]

Neonatal body composition

Timepoint [25]

by 72 hours of age

Secondary outcome [26]

Time below range glucose level more than 7.8 mmol/L

Timepoint [26]

from baseline (randomisation) until 72 hrs post randomisation, baseline until day 10 post randomisation, from baseline until day 20 post randomisation.

Secondary outcome [27]

Customised birthweight centile

Timepoint [27]

At given birth

Secondary outcome [28]

Infant length

Timepoint [28]

At given birth

Secondary outcome [29]

Severe Neonatal hypoglycemia

Timepoint [29]

from birth to 48 hours following birth

Secondary outcome [30]

Neonatal quadriceps thickness

Timepoint [30]

Within 72 hours of birth

Secondary outcome [31]

Biceps subcutaneous fat

Timepoint [31]

Within 72 hours of birth

Secondary outcome [32]

Neonatal quadriceps fat thickness

Timepoint [32]

Within 72 hours of birth

Secondary outcome [33]

Neonatal abdominal subcutaneous fat thickness

Timepoint [33]

Within 72 hours of birth

Secondary outcome [34]

Neonatal preperitoneal fat area

Timepoint [34]

Within 72 hours of birth

Eligibility

Key inclusion criteria

34 weeks’ gestation, with a singleton non-anomalous pregnancy
AND
T2D diagnosed prior to pregnancy, or
those without a pre-pregnancy diagnosis of T2D who have had a HbA1c <20 weeks’ gestation of greater than 49 mmol/mol
AND
Requiring pharmacologic glucose lowering therapy (metformin and or insulin) at the time of enrollment

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Antenatal corticosteroids administered within the previous 7 days,
planned birth within 14 days of enrolment,
unable to wear CGM for any reason,
unable to speak or understand English.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

None

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

The primary outcomes will be calculated as follows and presented as proportions with a 95% confidence interval:
• Recruitment total will be calculated as the number of participants who consent to the study and commence CGM monitoring (numerator) divided by the number of individuals identified as eligible during the study period (denominator)
• Recruitment approached will be calculated as the number of participants who consent to the study and commence CGM monitoring (numerator) divided by the number of individuals who are approached for enrolment during the study period (denominator)
• Retention will be calculated as the number of participants enrolled who continue to wear the CGM at day 20 of enrolment
• The proportion of enrolled participants who have at the end of the study (day 21 of enrolment) at least 15 days with at least 50% CGM readings (or pro rata equivalent until birth if this occurs in the study period) will be reported.
Among all eligible patients, the likelihood of being approached will be related to the demographic factors by logistic regression, with both univariable and multivariable analysis, expressed as odds ratio, with 95% confidence intervals. The explanatory variables are as follows:
• Older maternal age (>35 years)
• Multiparous (have previously given birth at or beyond a gestation of 20 week’s)
• Booking HbA1c >48 mmol/mol
• Booking BMI >30 kg/m2
• Insulin treatment
• Prioritised ethnicity
Among those approached by research staff, the likelihood of being consented will be similarly estimated as above.
For secondary quantitative outcomes, only descriptive statistics will be provided: frequency and proportion for categorical data, and mean, standard deviation and range for continuous data
Qualitative methods such as Clarke and Braun thematic analysis will be used to describe the acceptability of CGM, and acceptability of study participation.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

29/04/2025

Actual

Date of last participant enrolment

Anticipated

31/10/2025

Actual

Date of last data collection

Anticipated

25/12/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Auckland

Address [1]

Country [1]

New Zealand

Primary sponsor type

University

Name

The University of Auckland

Address

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Committee

Ethics committee address [1]

https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/02/2025

Approval date [1]

24/04/2025

Ethics approval number [1]

Summary

Brief summary

Using continuous glucose monitoring (CGM) in diabetes in pregnancy care improves outcomes for mothers with Type 1 diabetes and their babies, compared to self testing with fingerprick tests. People with type 2 diabetes (T2D) have high rates of pregnancy complications, however,  it is unclear if CGM use in pregnancy can provide better outcomes, and large well designed studies are required

Because CGM has only recently been funded in Aotearoa for people with T1D, the use of CGM is uncommon amongst people with T2D. Before starting a large trial, we need to confirm that potential participants with T2D in pregnancy can be recruited, randomised and retained to wear a CGM for a research study, and that the CGM device is useable and acceptable. 

The findings from this feasibility study will be used to plan a larger future study that can answer the question of whether CGM results in improved health outcomes for pregnant people with type 2 diabetes and their babies, compared to standard self-testing.

Trial website

TBA

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Charlotte Oyston

Address

Department of Obstetrics Gynaecology and Reproductive Science, Faculty of Medical and Health Sciences, University of Auckland Level 1 Building 507, 30 Park Avenue, Grafton, 1023 Auckland

Country

New Zealand

Phone

+64 9 3737599

Fax

[email protected]

Contact person for public queries

Name

Charlotte Oyston

Address

Department of Obstetrics Gynaecology and Reproductive Science, Faculty of Medical and Health Sciences, University of Auckland Level 1 Building 507, 30 Park Avenue, Grafton 1023 Auckland

Country

New Zealand

Phone

+64 9 3737599

Fax

[email protected]

Contact person for scientific queries

Name

Charlotte Oyston

Address

Department of Obstetrics Gynaecology and Reproductive Science, University of Auckland Level 1 Building 507, 30 Park Avenue, Grafton, 1023 Auckland

Country

New Zealand

Phone

+64 9 3737599

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers who are conducting research directly related to this study, where appropriate Data Management Plans are in place and that ethical approval for use has been obtained in accordance with local laws and regulations.

Conditions for requesting access:
• -

What individual participant data might be shared?

• If participants provide optional additional consent De-identified [and/or anonymised data] will be made available to other researchers on request for future research as specified above and / or will be added to data from other sources to form larger datasets.
In all cases, the Sponsor must be satisfied that appropriate Data Management Plans are in place and that ethical approval for use has been obtained in accordance with local laws and regulations.

What types of analyses could be done with individual participant data?

• Research directly related to this feasibility study aims.

When can requests for individual participant data be made (start and end dates)?

From:
Following publication of feasibility study findings, no end date.

To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: Contacting the principal investigator in writing ([email protected])

• Contacting the principal investigator in writing ([email protected])

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

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