Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000050257
Ethics application status
Approved
Date submitted
13/12/2017
Date registered
16/01/2018
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Glucose Monitoring (CGM) for women with Gestational Diabetes Mellitus (GDM) study: pilot
Scientific title
Incorporating Continuous Glucose Monitoring (CGM) into a Gestational Diabetes Mellitus
(GDM) Model of Care to Enhance the Efficient Use of Health Care Resources: Pilot
Secondary ID [1] 293585 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes 305830 0
Condition category
Condition code
Metabolic and Endocrine 305044 305044 0 0
Diabetes
Reproductive Health and Childbirth 305187 305187 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women with gestational diabetes (GDM) diagnosed on 75g- oral glucose tolerance testing (OGTT) performed between 24 to 28 weeks will be offered blinded continuous glucose monitoring (CGM) (iPro) insertion for a week in addition to routine fingerprick testing. They will also record length of time of health care professional visits for the duration of the pregnancy.

The aim of this study is to:
(a) To determine if data provided by a blinded CGM trace of 7 days duration performed during the two week interval following the 24-28 week OGTT in pregnancy can be used for the triage of GDM patients into groups that are either likely or unlikely to require intensification of their clinical care during the remainder of their pregnancy (primary objective).
(b) To compare glycaemic profiles provided by the 24-28 week OGTT, fingerprick glucose readings performed in the week post-OGTT and CGM traces as predictors of utilisation of health care resources.
(c) To propose a set of CGM parameters as therapeutic targets for patients with GDM.
(d) To provide data informing a model of care incorporating CGM technology as part of standard practice.

Intervention code [1] 299839 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304205 0
Total contact time (minutes) with healthcare professionals (obstetricians, endocrinologists, midwives, diabetes nurse educators and dieticians) post 24-28 week 75g OGTT.

Participants will keep a record for every healthcare professional (HCP) visit detailing type of HCP seen and duration of consultation until delivery
Timepoint [1] 304205 0
From entry to the study until end of pregnancy/ Delivery date
Secondary outcome [1] 341250 0
1. Clinic visits (n) post 75g-OGTT

Participants will keep a record for every healthcare professional (HCP) visit detailing type of HCP seen and duration of consultation until delivery
Timepoint [1] 341250 0
From entry to the study until end of pregnancy/ Delivery date
Secondary outcome [2] 341251 0
2. Obstetrician contact time (minutes) post 75g-OGTT
Participants will keep a record for every healthcare professional (HCP) visit detailing type of HCP seen and duration of consultation until delivery
Timepoint [2] 341251 0
From entry to the study until end of pregnancy/ Delivery date
Secondary outcome [3] 341646 0
3. Endocrinologist contact time (minutes) post 75g-OGTT
Participants will keep a record for every healthcare professional (HCP) visit detailing type of HCP seen and duration of consultation until delivery
Timepoint [3] 341646 0
From entry to the study until end of pregnancy/ Delivery date
Secondary outcome [4] 341653 0
4. Diabetes Nurse Educator contact time (minutes) post 75g-OGTT
Participants will keep a record for every healthcare professional (HCP) visit detailing type of HCP seen and duration of consultation until delivery
Timepoint [4] 341653 0
From entry to the study until end of pregnancy/ Delivery date
Secondary outcome [5] 341654 0
5. Dietician contact time (minutes) post 75g OGTT
Participants will keep a record for every healthcare professional (HCP) visit detailing type of HCP seen and duration of consultation until delivery
Timepoint [5] 341654 0
From entry to the study until end of pregnancy/ Delivery date
Secondary outcome [6] 341655 0
6. Midwife contact time (minutes) post 75g-OGTT
Participants will keep a record for every healthcare professional (HCP) visit detailing type of HCP seen and duration of consultation until delivery
Timepoint [6] 341655 0
From entry to the study until end of pregnancy/ Delivery date
Secondary outcome [7] 341656 0
7. Gestation at insulin initiation and final total dose of insulin
Data collection from medical records
Timepoint [7] 341656 0
From entry to the study until end of pregnancy/ Delivery date
Secondary outcome [8] 341657 0
8. Performance (accuracy and durability) of the iPro system in pregnant women

CGM data will be compared with fingerprick BGL readings
Timepoint [8] 341657 0
For 1 week from the start of CGM insertion
Secondary outcome [9] 341658 0
Maternal Outcomes: Mode of delivery
Data collection from medical records
Timepoint [9] 341658 0
End of pregnancy/ Delivery date
Secondary outcome [10] 341659 0
Maternal Outcomes: -Gestation at delivery
Data collection from medical records
Timepoint [10] 341659 0
End of pregnancy/ Delivery date
Secondary outcome [11] 341660 0
Maternal Outcomes: -Pre-eclampsia
Data collection from medical records
Timepoint [11] 341660 0
End of pregnancy/ Delivery date
Secondary outcome [12] 341661 0
Maternal Outcomes: -Pregnancy-induced hypertension (PIH)
Data collection from medical records
Timepoint [12] 341661 0
End of pregnancy/ Delivery date
Secondary outcome [13] 341662 0
Maternal Outcomes: -Post-partum haemorrhage (PPH)
Data collection from medical records
Timepoint [13] 341662 0
End of pregnancy/ Delivery date
Secondary outcome [14] 341663 0
Fetal outcomes: -Gestation & birthweight
Data collection from medical records
Timepoint [14] 341663 0
Date of birth
Secondary outcome [15] 341664 0
Fetal outcomes: -Macrosomia
Data collection from medical records
Timepoint [15] 341664 0
Date of birth
Secondary outcome [16] 341665 0
Fetal outcomes: -Large for gestational age
Data collection from medical records
Timepoint [16] 341665 0
Date of birth
Secondary outcome [17] 341666 0
Fetal outcomes: -Small for gestational age
Data collection from medical records
Timepoint [17] 341666 0
Date of birth
Secondary outcome [18] 341667 0
Fetal outcomes: -Neonatal hypoglycaemia
Data collection from medical records
Timepoint [18] 341667 0
Date of birth
Secondary outcome [19] 341668 0
Fetal outcomes: -Need for SCN/NICU admission
Data collection from medical records
Timepoint [19] 341668 0
Date of birth
Secondary outcome [20] 341669 0
Fetal outcomes: -Apgar scores at 1’ and 5’
Data collection from medical records
Timepoint [20] 341669 0
Date of birth
Secondary outcome [21] 341670 0
Fetal outcomes: -Shoulder dystocia
Data collection from medical records
Timepoint [21] 341670 0
Date of birth
Secondary outcome [22] 341671 0
Fetal outcomes: -Congenital abnormalities
Data collection from medical records
Timepoint [22] 341671 0
Date of birth

Eligibility
Key inclusion criteria
-Pregnant
-GDM diagnosed at 24-28 week gestation based on routine 75g-OGTT
-Willing to wear CGM
-Willing to perform 4 self-monitored blood glucose (SMBG) readings each day
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-Pre-existing diabetes (type 1 or type 2 diabetes)
-Early GDM diagnosed prior to 24 weeks gestation
-Multiple pregnancy
-Known major congenital abnormality for current pregnancy
-Maternal age <18 years
-Allergic reaction to adhesive dressing
-Other major maternal medical co-morbidities requiring intensive clinical follow-up
-Already on treatment (metformin or insulin) for GDM management

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study, aiming for total 100 participants with 50 participants at each site (Werribee Mercy Hospital and Mercy Hospital for Women). Women will be stratified according to risk according to OGTT results and clinical risk factors (3 groups: minor, intermediate, significant risk). CGM data will be analysed for variability and time within range to assess whether it predicts likelihood of treatment or adverse outcomes. Primary outcome of total contact time with healthcare professionals will be used to ascertain potential health economic benefits if CGM data helped rationalise use of HCP time.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2018
Actual
8/02/2018
Date of last participant enrolment
Anticipated
31/03/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9527 0
Werribee Mercy Hospital - Werribee
Recruitment hospital [2] 9528 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 18277 0
3030 - Werribee
Recruitment postcode(s) [2] 18278 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 298203 0
Commercial sector/Industry
Name [1] 298203 0
Medtronic Australasia
Country [1] 298203 0
Australia
Primary sponsor type
Hospital
Name
Mercy Health (Werribee Mercy Hospital)
Address
300 Princes Hwy, Werribee VIC 3030
Country
Australia
Secondary sponsor category [1] 297301 0
Hospital
Name [1] 297301 0
Mercy Health (Mercy Hospital for Women)
Address [1] 297301 0
163 Studley Rd, Heidelberg VIC 3084
Country [1] 297301 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299211 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 299211 0
Mercy Health
Level 2, 12 Shelley Street
Richmond VIC 3121
Ethics committee country [1] 299211 0
Australia
Date submitted for ethics approval [1] 299211 0
21/08/2017
Approval date [1] 299211 0
19/10/2017
Ethics approval number [1] 299211 0
2017-039

Summary
Brief summary
Updated criteria for the diagnosis of gestational diabetes (GDM) mean that larger numbers (approximately 18%) of women screened meet diagnostic criteria placing an increasing burden upon limited healthcare professional (HCP) resources. We hypothesise that while the 75g OGTT provides the standard for the diagnosis of GDM, continuous glucose monitoring (CGM) technology could provide a useful adjunct increasing efficiencies in patient care by more effectively triaging patients according to CGM profiles to identify those most likely to require intervention and expediting therapeutic decision-making by the health professional with the provision of more detailed data.

All women with GDM diagnosed on OGTT between 24 to 28 weeks gestation will be offered retrospective CGM for a week, in addition to routine fingerprick glucose monitoring. They will also keep a record of HCP visits and time spent for the duration of the pregnancy. GDM management and maternal-fetal outcome data will be collected from medical records. Both OGTT (glucose levels) and CGM profiles (glucose levels and glycaemic variability) will be compared with subsequent therapeutic interventions, healthcare resource utilization and clinical outcomes to determine whether a set of criteria based on the glucose data obtained prior to 31 weeks can be employed to triage patients to either routine or more intensive follow up.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79670 0
Prof David N O'Neal
Address 79670 0
Werribee Mercy Hospital
300 Princes Hwy, Werribee VIC 3030
Country 79670 0
Australia
Phone 79670 0
+613 87543206
Fax 79670 0
Email 79670 0
dno@unimelb.edu.au
Contact person for public queries
Name 79671 0
Dr Jessie Teng
Address 79671 0
Werribee Mercy Hospital
300 Princes Hwy, Werribee VIC 3030
Country 79671 0
Australia
Phone 79671 0
+613 87543000
Fax 79671 0
Email 79671 0
jteng@mercy.com.au
Contact person for scientific queries
Name 79672 0
Dr Balasubramanian Krishnamurthy
Address 79672 0
Werribee Mercy Hospital
300 Princes Hwy, Werribee VIC 3030
Country 79672 0
Australia
Phone 79672 0
+613 87543000
Fax 79672 0
Email 79672 0
bmurthy@svi.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4687Study results articleYes Zaharieva DP, Teng JH, Ong ML, Lee MH, Paldus B, J... [More Details] 374153-(Uploaded-01-12-2020-12-15-19)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.