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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
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Scientific title
Continuous Glucose monitoring for Type 2 Diabetes in Pregnancy: a Feasibility Study
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Secondary ID [1]
313933
0
Nil known
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Universal Trial Number (UTN)
U1111-1319-0799
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes
336698
0
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Pregnancy
336699
0
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Condition category
Condition code
Metabolic and Endocrine
333198
333198
0
0
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Diabetes
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Reproductive Health and Childbirth
333199
333199
0
0
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Antenatal care
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330563
0
Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
340762
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Recruitment
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Assessment method [1]
340762
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A waiver of consent is obtained to identify all persons referred with Type 2 diabetes to our service over the recruitment time period, alongside their estimated date of delivery. A record of all potentially eligible persons will be entered into a RedCAP screening database, and records updated to indicate when a person is approached to participate. From this screening database, the proportion of all eligible people approached who consent to participate (approached response), and the proportion of all people eligible during the study period who consent to participate (overall response).
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Timepoint [1]
340762
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Assessed at the recruitment period
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Primary outcome [2]
340763
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Retention
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Assessment method [2]
340763
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Participants have planned telephone contact at day 11, day 21 where an enquiry is made to ensure that there are no issues wearing the CGM. The duration of wear of CGM as reported by the participant is recorded in the RedCAP form. Audit of this form will be used to report the proportion of consented participants who continue to wear the CGM at day 20 of the study (or until established labour / cesarean section, if this occurs sooner).
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Timepoint [2]
340763
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Day 21 following randomisation or at day of established labour / cesarean section (if occurs sooner)
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Primary outcome [3]
340764
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Obtaining a minimum CGM dataset
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Assessment method [3]
340764
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the proportion of consented participants that we can obtain through the Clarity app, at least 15 days of at least 50% CGM readings (or pro rata equivalent number of days if birth occurs in the study period).
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Timepoint [3]
340764
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Day 21 following randomisation
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Secondary outcome [1]
445012
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Reasons for declining entry.
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Assessment method [1]
445012
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Reported by approached individual at time of approach
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Timepoint [1]
445012
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Baseline
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Secondary outcome [2]
445013
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Reasons for non-retention or study dropout.
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Assessment method [2]
445013
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semi structured exit interview with a member of the research team who has not been involved in recruitment of support, and has not provided clinical care through the study period
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Timepoint [2]
445013
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Day 21 or as soon as practicable after study cessation.
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Secondary outcome [3]
445014
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Completeness of data CGM data
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Assessment method [3]
445014
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Clarity app - time active for each participant (the number of hours the sensor has collected data as a proportion of the number of hours of CGM use).
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Timepoint [3]
445014
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Day 21 or at day of established labour / cesarean section (if occurs sooner)
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Secondary outcome [4]
445015
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Staff contact regarding CGM (not relating to diabetes management)
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Assessment method [4]
445015
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From patient contact log - number of times participant has contacted research staff with a query or concern about CGM that is not relating to diabetes management, and reason for contact.
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Timepoint [4]
445015
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Day 21 or at day of established labour / cesarean section (if occurs sooner)
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Secondary outcome [5]
445016
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acceptability of the CGM for participants
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Assessment method [5]
445016
0
semi structured exit interview with a member of the research team who has not been involved in recruitment of support, and has not provided clinical care through the study period
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Timepoint [5]
445016
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Day 21 or as soon as practicable after study cessation.
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Secondary outcome [6]
445017
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acceptability of participation in the research study and a future masked trial
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Assessment method [6]
445017
0
semi structured exit interview with a member of the research team who has not been involved in recruitment of support, and has not provided clinical care through the study period
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Timepoint [6]
445017
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Day 21 or as soon as practicable after study cessation.
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Secondary outcome [7]
445018
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Diabetes related distress score (DDS-17)
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Assessment method [7]
445018
0
Diabetes distress score (DDS-17)
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Timepoint [7]
445018
0
baseline and Day 21 (or as soon as practicable after study cessation)
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Secondary outcome [8]
445019
0
CGM glycaemic metrics o Time in range (3.5 – 7.8 mmol/L)
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Assessment method [8]
445019
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Clarity app
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Timepoint [8]
445019
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from baseline (randomisation) until 72 hrs post randomisation, baseline until day 10 post randomisation, from baseline until day 20 post randomisation.
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Secondary outcome [9]
445020
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Completeness of self-monitoring data
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Assessment method [9]
445020
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Diabetes in pregnancy self-record sheet. Proportion of people who continue to self-monitor at least 4 times daily whilst wearing CGM (determined from clinical self-monitoring records).
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Timepoint [9]
445020
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From baseline until day day 21 post randomisation
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Secondary outcome [10]
445021
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Completeness of questionnaire data
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Assessment method [10]
445021
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Proportion of people who complete all questionnaire questions at baseline and conclusion of the study,
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Timepoint [10]
445021
0
baseline, day 21 (or as soon as practicable after study cessation)
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Secondary outcome [11]
445023
0
Maternal weight gain
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Assessment method [11]
445023
0
Digital weighing scales used to weigh at enrolment for baseline, and weight (recorded using digital weighing scales) most recent to given birth recorded from clinical record.
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Timepoint [11]
445023
0
At baseline (randomisation) and within 1 week prior to giving birth
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Secondary outcome [12]
445024
0
Severe maternal hypoglycemia (blood glucose <2.8 mmol/L) during study period
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Assessment method [12]
445024
0
Clarity app, self monitoring record
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Timepoint [12]
445024
0
Throughout enrolment from baseline (randomisation) until day 21 post randomisation (or day of active labour / cesarean birth if this is sooner).
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Secondary outcome [13]
445025
0
Diabetic ketoacidosis during study period
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Assessment method [13]
445025
0
Clinical record review
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Timepoint [13]
445025
0
Throughout enrolment from baseline (randomisation) until day 21 post randomisation (or day of active labour / cesarean birth if this is sooner).
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Secondary outcome [14]
445026
0
Presence of hypertensive disorder
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Assessment method [14]
445026
0
From clinical record review, presence of pregnancy induced hypertension or pre-eclampsia (as per SOMANZ).
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Timepoint [14]
445026
0
Throughout enrolment from baseline (randomisation) until day 21 post randomisation (or day of active labour / cesarean birth if this is sooner).
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Secondary outcome [15]
445027
0
Induction of labour
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Assessment method [15]
445027
0
From clinical record review, presence or absence of induction of labour documented.
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Timepoint [15]
445027
0
At given birth
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Secondary outcome [16]
445029
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Maternal death
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Assessment method [16]
445029
0
From clinical record review, did maternal death occur.
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Timepoint [16]
445029
0
Day 21, or day of active labour / cesarean birth (if this is sooner)
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Secondary outcome [17]
445030
0
Infant birth weight
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Assessment method [17]
445030
0
Clinical record, for birthweight.
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Timepoint [17]
445030
0
At given birth
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Secondary outcome [18]
445031
0
Gestational age at given birth
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Assessment method [18]
445031
0
Clinical record, gestational age, preterm birth (<37 weeks')
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Timepoint [18]
445031
0
At given birth
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Secondary outcome [19]
445032
0
Mode of birth
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Assessment method [19]
445032
0
Clinical record to determine sponatenous vaginal, assisted vaginal, planned caesarean, emergency caesarean
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Timepoint [19]
445032
0
At given birth
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Secondary outcome [20]
445033
0
Shoulder dystocia
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Assessment method [20]
445033
0
Clinical record, documentation of additional manoueveres being required for delivery of the fetal shoulders at vaginal birth.
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Timepoint [20]
445033
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At given birth
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Secondary outcome [21]
445034
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Neonatal hypoglycaemia (at least 1 BGC <2.6 mmol/L),
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Assessment method [21]
445034
0
Clinical record review to document the number of episodes.
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Timepoint [21]
445034
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48hrs of age
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Secondary outcome [22]
445035
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Requirement for neonatal respiratory support
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Assessment method [22]
445035
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Clinical record review: positive pressure respiratory support of 4 hours or more (CPAP, high flow, mechanical ventilation), Main respiratory diagnosis (as per ANZNN)
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Timepoint [22]
445035
0
2 weeks of age
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Secondary outcome [23]
445036
0
Stillbirth or early neonatal death
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Assessment method [23]
445036
0
Clinical record
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Timepoint [23]
445036
0
7 days of age
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Secondary outcome [24]
445037
0
Neonatal bicep thickness
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Assessment method [24]
445037
0
ultrasound measurement of biceps thickness (mm)
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Timepoint [24]
445037
0
by 72 hours of age
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Secondary outcome [25]
445038
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Neonatal body composition
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Assessment method [25]
445038
0
Total percentage neonatal body fat as measured by PeaPOD Air displacement plethysmography measurements
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Timepoint [25]
445038
0
by 72 hours of age
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Secondary outcome [26]
445692
0
Time below range glucose level more than 7.8 mmol/L
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Assessment method [26]
445692
0
Clarity app
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Timepoint [26]
445692
0
from baseline (randomisation) until 72 hrs post randomisation, baseline until day 10 post randomisation, from baseline until day 20 post randomisation.
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Secondary outcome [27]
445703
0
Customised birthweight centile
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Assessment method [27]
445703
0
Clinical record, for customised birthweight centile
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Timepoint [27]
445703
0
At given birth
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Secondary outcome [28]
445704
0
Infant length
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Assessment method [28]
445704
0
clinical record for length z score
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Timepoint [28]
445704
0
At given birth
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Secondary outcome [29]
445705
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Severe Neonatal hypoglycemia
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Assessment method [29]
445705
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Clinical record to calculate the number of severe episodes (at least 1 BGC <2.0 mmol/L) of neonatal hypoglycemia.
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Timepoint [29]
445705
0
from birth to 48 hours following birth
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Secondary outcome [30]
445708
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Neonatal quadriceps thickness
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Assessment method [30]
445708
0
Neonatal ultrasound measurement of quadriceps thickness (mm)
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Timepoint [30]
445708
0
Within 72 hours of birth
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Secondary outcome [31]
445709
0
Biceps subcutaneous fat
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Assessment method [31]
445709
0
Neonatal ultrasound measurement of biceps sub cutaneous fat thickness (mm)
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Timepoint [31]
445709
0
Within 72 hours of birth
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Secondary outcome [32]
445710
0
Neonatal quadriceps fat thickness
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Assessment method [32]
445710
0
Ultrasound measure of neonatal quadriceps fat thickness (mm)
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Timepoint [32]
445710
0
Within 72 hours of birth
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Secondary outcome [33]
445711
0
Neonatal abdominal subcutaneous fat thickness
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Assessment method [33]
445711
0
Ultrasound measure of abdominal subcutaneous fat thickness (mm)
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Timepoint [33]
445711
0
Within 72 hours of birth
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Secondary outcome [34]
445712
0
Neonatal preperitoneal fat area
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Assessment method [34]
445712
0
Ultrasound measure of neonatal preperitoneal fat area (cm2)
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Timepoint [34]
445712
0
Within 72 hours of birth
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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
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
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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)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
29/04/2025
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Actual
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Date of last participant enrolment
Anticipated
31/10/2025
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Actual
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Date of last data collection
Anticipated
25/12/2025
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26896
0
New Zealand
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State/province [1]
26896
0
Auckland
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Funding & Sponsors
Funding source category [1]
318418
0
University
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Name [1]
318418
0
The University of Auckland
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Address [1]
318418
0
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Country [1]
318418
0
New Zealand
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Primary sponsor type
University
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Name
The University of Auckland
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Address
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Country
New Zealand
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Secondary sponsor category [1]
320807
0
None
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Name [1]
320807
0
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Address [1]
320807
0
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Country [1]
320807
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317046
0
Northern A Health and Disability Ethics Committee
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Ethics committee address [1]
317046
0
https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/
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Ethics committee country [1]
317046
0
New Zealand
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Date submitted for ethics approval [1]
317046
0
08/02/2025
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Approval date [1]
317046
0
24/04/2025
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Ethics approval number [1]
317046
0
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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.
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Trial website
TBA
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
139818
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Dr Charlotte Oyston
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Address
139818
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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
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Country
139818
0
New Zealand
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Phone
139818
0
+64 9 3737599
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Fax
139818
0
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Email
139818
0
[email protected]
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Contact person for public queries
Name
139819
0
Charlotte Oyston
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Address
139819
0
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
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Country
139819
0
New Zealand
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Phone
139819
0
+64 9 3737599
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Fax
139819
0
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Email
139819
0
[email protected]
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Contact person for scientific queries
Name
139820
0
Charlotte Oyston
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Address
139820
0
Department of Obstetrics Gynaecology and Reproductive Science, University of Auckland Level 1 Building 507, 30 Park Avenue, Grafton, 1023 Auckland
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Country
139820
0
New Zealand
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Phone
139820
0
+64 9 3737599
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Fax
139820
0
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Email
139820
0
[email protected]
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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?
No
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.
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