Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000980235
Ethics application status
Approved
Date submitted
3/04/2018
Date registered
12/06/2018
Date last updated
12/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of steroid effects on glucose and ketone levels in women with diabetes mellitus in pregnancy using novel glucose monitoring devices.
Scientific title
Steroids With Examination and Evaluation of glucose sensing Technology and Ketones in women with diabetes mellitus in Pregnancy (SWEET KIP study)
Secondary ID [1] 294455 0
None
Universal Trial Number (UTN)
Trial acronym
SWEET KIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 307204 0
Pregnancy 307622 0
Condition category
Condition code
Metabolic and Endocrine 306315 306315 0 0
Diabetes
Reproductive Health and Childbirth 306688 306688 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 2 doses of IM betamethasone 11.4mg 24 hours apart by the nurse in charge. Each participant will have a Flash glucose monitoring and a continuous glucose monitoring device inserted on the day of admission, prior to IM betamethasone administration. The glucose monitoring devices will be inserted by the study team member. The FGM device will be inserted into the upper outer aspect of the arm, while the CGM device will be inserted on the lower abdomen. This will be in addition to hourly capillary glucose monitoring which is part of routine care, which commences after betamethasone administration.

On day 2 of admission, the participants will have hourly venous blood drawn for glucose and ketones levels. 4 hourly urine ketones will also be collected on this day. IV insulin infusion will be initiated during hospitalisation, as per standard protocol/ medical care, with the rates adjusted according to the hourly capillary blood glucose readings. The IV insulin infusion can be initiated from day 2 of admission or earlier if blood glucose levels are high prior to IM betamethasone administration. Participants will be monitored till day after the second dose of IM betamethasone or until delivery, depending on Obstetrics indication. Hourly blood draws/ urine tests for the study will only be for the 2nd day after steroid use. Participants are encouraged to contInue the use of FGM/ CGM devices while hospitalized and on discharge (or till delivery)- maximum wear of 6 days for CGM and 2 weeks for FGM.

The accuracy of interstitial glucose levels as monitored by the flash glucose monitoring and continuous glucose monitoring devices will be compared against venous glucose retrospectively.
Intervention code [1] 300746 0
Treatment: Devices
Comparator / control treatment
No control group. We will be comparing the devices against gold standard- venous blood glucose.
Control group
Active

Outcomes
Primary outcome [1] 305328 0
Assess the accuracy of interstitial fluid glucose measures (Flash glucose monitoring [FGM], continuous glucose monitoring [CGM]) against capillary blood glucose and venous blood glucose measurement. We will be comparing the mean absolute difference (MAD), mean absolute relative difference (MARD), median absolute difference (MedAD) and median absolute relative difference (MedARD) of FGM and CGM against venous blood glucose.
Timepoint [1] 305328 0
Hourly monitoring of venous blood glucose with comparison against the interstitial blood glucose levels for 9 hours, commencing 9 hours after IM betamethasone injection.

This will be composite primary outcome.
Primary outcome [2] 305329 0
Compare accuracy of capillary blood ketone levels against venous blood beta-hydroxy-butyrate by mean absolute difference, and evaluate if urine ketone assessment corresponds with blood ketone assessment.
Timepoint [2] 305329 0
4 hourly urine ketones and hourly venous beta-hydroxybutyrate measurement against capillary blood ketones for 9 hours.

This will be composite secondary outcome.
Secondary outcome [1] 346187 0
Evaluate degree of hyperglycaemia after IM betamethasone in women with diabetes mellitus. This will be done by evaluating the interstitial glucose levels documented on FGM/ CGM devices, and serial venous blood glucose levels.
Timepoint [1] 346187 0
CGM and FGM devices will be worn prior to IM betamethasone administration, up to the point of delivery or for as long as participants are keen to continue wearing the devices (up to 2 weeks for FGM device, and up to 6 days for CGM device).
Secondary outcome [2] 347085 0
Evaluate temporal onset of hyperglycemia after betamethasone administration.
Timepoint [2] 347085 0
CGM and FGM devices will be worn prior to IM betamethasone administration, up to the point of delivery or for as long as participants are keen to continue wearing the devices (up to 2 weeks for FGM device, and up to 6 days for CGM device).

Eligibility
Key inclusion criteria
Pregnant women requiring IM betamethasone, between 24-36 weeks gestation.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient who declined to participate in study

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299079 0
Hospital
Name [1] 299079 0
Mater Research Funding (Mater Mothers Hospital)
Country [1] 299079 0
Australia
Primary sponsor type
Hospital
Name
Mater Research Funding (Mater Mothers Hospital)
Address
Level 3, Aubigny Place, Raymond Terrace, South Brisbane Qld 4101
Country
Australia
Secondary sponsor category [1] 298620 0
None
Name [1] 298620 0
None
Address [1] 298620 0
None
Country [1] 298620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300015 0
Mater Misericordiae Ltd Human Research Ethics Committee (EC00332)
Ethics committee address [1] 300015 0
Ethics committee country [1] 300015 0
Australia
Date submitted for ethics approval [1] 300015 0
03/04/2018
Approval date [1] 300015 0
14/05/2018
Ethics approval number [1] 300015 0
HREC/18/MHS/42

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

Contacts
Principal investigator
Name 82266 0
Dr Josephine Laurie
Address 82266 0
Mater Health Services
Level 1 Room 9 Whitty Building. Mater Health Services
South Brisbane, Qld 4101
Country 82266 0
Australia
Phone 82266 0
+61 407404 097
Fax 82266 0
Email 82266 0
[email protected]
Contact person for public queries
Name 82267 0
Weiying Lim
Address 82267 0
Mater Mothers Hospital
Endocrine Department
Level 2 Annerley Rd Campus
41 Annerley Rd South Brisbane QLD 4101
Country 82267 0
Australia
Phone 82267 0
+61 435711791
Fax 82267 0
Email 82267 0
[email protected]
Contact person for scientific queries
Name 82268 0
Weiying Lim
Address 82268 0
Mater Mothers Hospital
Endocrine Department
Level 2 Annerley Rd Campus
41 Annerley Rd South Brisbane QLD 4101
Country 82268 0
Australia
Phone 82268 0
+61 435711791
Fax 82268 0
Email 82268 0
[email protected]

No information has been provided regarding IPD availability


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.