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Trial registered on ANZCTR


Registration number
ACTRN12614001250628
Ethics application status
Approved
Date submitted
15/11/2014
Date registered
1/12/2014
Date last updated
20/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Glucose Targets in gestational diabetes Pilot
Scientific title
An evaluation of the safety of very tight glycaemic control versus tight glycaemic control in women with gestational diabetes
Secondary ID [1] 285680 0
Nil known
Universal Trial Number (UTN)
U1111-1164-1575
Trial acronym
GluT pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 293535 0
Condition category
Condition code
Reproductive Health and Childbirth 293802 293802 0 0
Antenatal care
Metabolic and Endocrine 293852 293852 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Very tight glycaemic control as monitored by self blood glucose monitoring with a memory glucometer, aiming to keep fasting capillary blood glucose <5.0 mmol/L and 2 hour post prandial capillary blood glucose <6.7 mmol/L until delivery, using diet, exercise, insulin, other drugs, as necessary, and at appropriate doses to maintain the control, under the supervision of an obstetric physician and a diabetes nurse educator
Intervention code [1] 290618 0
Lifestyle
Intervention code [2] 290619 0
Treatment: Drugs
Comparator / control treatment
Tight glycaemic control as monitored by self blood glucose monitoring with a memory glucometer, aiming to keep fasting capillary blood glucose <5.5 mmol/L and 2 hour post prandial capillary blood glucose <7.0 mmol/L until delivery, using diet, exercise, insulin, other drugs, as necessary, and at appropriate doses to maintain the control, under the supervision of an obstetric physician and a diabetes nurse educator
Control group
Active

Outcomes
Primary outcome [1] 293596 0
maternal hypoglycaemia: self monitoring capillary blood glucose <3.0 mmol/L - number of episodes, symptomatic or not.
Timepoint [1] 293596 0
following initiation of diet and lifestyle changes and hypoglycaemic therapy as required until delivery
Primary outcome [2] 293684 0
severe maternal hypoglycaemia: self monitoring capillary blood glucose <2.5 mmol/L - number of episodes.
Timepoint [2] 293684 0
following initiation of diet and lifestyle changes and hypoglycaemic therapy as required until delivery
Secondary outcome [1] 311431 0
Birthweight
Timepoint [1] 311431 0
At delivery
Secondary outcome [2] 311432 0
neonatal hypoglycaemia in whole blood from heel prick <2.6 mmol/L
Timepoint [2] 311432 0
4 hours of age
Secondary outcome [3] 311591 0
severe neonatal hypoglycaemia in whole blood from heel prick <2.0 mmol/L
Timepoint [3] 311591 0
at 4 hours of age

Eligibility
Key inclusion criteria
Pregnant women with gestational diabetes diagnosed on 75g OGTT: fasting glucose >=5.5 mmol/L and 2h glucose >=8.5 mmol/L, between 12 and 30 weeks gestation, with a singleton or twin pregnancy, not previously diagnosed as diabetic, attending antenatal care at collaborating hospitals, and giving informed written consent
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
>30+0 weeks gestation, or with triplets or higher order gravidity, or with major active medical disorders (including psychiatric disease requiring antipsychotic medication and inflammatory disorders requiring corticosteroid therapy, but not including chronic hypertension)

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis
Clinical assessment of possible increased frequency of significant maternal hypoglycaemia in intervention group
This is a pilot study to assess potential issues and sample size before commencing a larger trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3145 0
Womens and Childrens Hospital - North Adelaide

Funding & Sponsors
Funding source category [1] 290249 0
Commercial sector/Industry
Name [1] 290249 0
Novo Nordisk Regional Support Scheme for 2013
Address [1] 290249 0
Novo Nordisk Pharmaceuticals Pty. Ltd.
Level 3
21 Solent Circuit
Baulkham Hills NSW 2153
Australia
Country [1] 290249 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Road
North Adelaide
SA 5006
Country
Australia
Secondary sponsor category [1] 288955 0
University
Name [1] 288955 0
Robinson Research Institute
University of Adelaide
Address [1] 288955 0
55 King William Road
North Adelaide
SA 5006
Country [1] 288955 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291950 0
Women's and Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 291950 0
72 King William Road
North Adelaide
SA 5006
Ethics committee country [1] 291950 0
Australia
Date submitted for ethics approval [1] 291950 0
Approval date [1] 291950 0
03/09/2014
Ethics approval number [1] 291950 0
HREC/13/WCHN/157

Summary
Brief summary
A pilot study of maternal and neonatal outcomes of pregnancies complicated by gestational diabetes, including significant maternal hypoglycaemia and lack of neonatal hypoglycaemia: the main hypothesis is that these will not differ when receiving treatment aimed at achieving ‘very tight’ blood glucose targets, compared with treatment aimed at achieving ‘tight’ blood glucose targets
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52822 0
Prof William "Bill" Hague
Address 52822 0
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 52822 0
Australia
Phone 52822 0
+61 4 11114575
Fax 52822 0
Email 52822 0
bill.hague@adelaide.edu.au
Contact person for public queries
Name 52823 0
Dr Suzette Coat
Address 52823 0
Robinson Research Institute
55 King William Road
North Adelaide
SA 5006
Country 52823 0
Australia
Phone 52823 0
+61 8 83131338
Fax 52823 0
Email 52823 0
suzette.coat@adelaide.edu.au
Contact person for scientific queries
Name 52824 0
Prof William "Bill" Hague
Address 52824 0
Women's and Children's Hospital
72 King William Road
North Adelaide
SA 5006
Country 52824 0
Australia
Phone 52824 0
+61 4 11114575
Fax 52824 0
Email 52824 0
bill.hague@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
No Results