Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001295639
Ethics application status
Approved
Date submitted
19/11/2014
Date registered
11/12/2014
Date last updated
10/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Clinical Utility of Glycated Albumin as an Index of Glycaemic Control in Type 1 Diabetic Pregnancy and its ability to predict Neonatal Outcome
Scientific title
The Clinical Utility of Glycated Albumin as an Index of Glycaemic Control in Type 1 Diabetic Pregnancy and its ability to predict Neonatal Outcome
Secondary ID [1] 285702 0
None
Universal Trial Number (UTN)
Trial acronym
Glycated Albumin in Type 1 Diabetic Pregnancy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 293565 0
Pregnancy 293566 0
Condition category
Condition code
Metabolic and Endocrine 293850 293850 0 0
Diabetes
Reproductive Health and Childbirth 293851 293851 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Self-monitoring of blood glucose
Continuous glucose monitoring (carried out for 6 days at a time at each of the three timepoints illustrated below) and measurement of indices of glycaemic control at three timepoints throughout pregnancy (14-18 weeks gestation; 24-28 weeks gestation; 32-26 weeks gestation):
- HbA1c
- Fructosamine
- Glycated Albumin
- 1,5-anhydroglucitol
Intervention code [1] 290647 0
Not applicable
Comparator / control treatment
There is no control group for this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293630 0
The correlation of measures of glycaemic control (as assessed by glycated albumin, HbA1c, fructosamine and 1,5-anhydroglucitol values) obtained throughout pregnancy with maternal and neonatal outcomes, particularly the incidence of macrosomia. Maternal and neonatal outcomes will be assessed by reviewing medical records and routine clinical data following delivery.
Maternal outcomes to be assessed include:
- Method of delivery (e.g. induction of labour, caesarean section)
- Perineal lacerations
- Postpartum haemorrhage
- Complications in labour
Neonatal outcomes to be assessed include:
- Birth weight
- Gestational age at birth
- Incidence of neonatal death
- Shoulder dystocia
- Bone fracture
- Nerve palsy
- Admission to neonatal intensive care unit (NICU)
- Hypoglycaemia
- Jaundice and/or jaundice requiring phototherapy
- Respiratory distress
Timepoint [1] 293630 0
Post-pregnancy/delivery date
Secondary outcome [1] 311492 0
The correlation of glycated albumin, HbA1c, fructosamine and 1,5-anhydroglucitol values obtained throughout pregnancy with fetal hypoglycaemia in the first 24 hours after delivery. Fetal hypoglycaemia is routinely assessed as part of standard clinical care for babies born to mothers with type 1 diabetes in pregnancy.
Timepoint [1] 311492 0
24 hours after delivery
Secondary outcome [2] 311493 0
The correlation of glycated albumin, HbA1c, fructosamine and 1,5-anhydroglucitol values obtained throughout pregnancy with fetal indices of glycaemic control including cord blood glucose, insulin and c-peptide.
Timepoint [2] 311493 0
Post-pregnancy/delivery date
Secondary outcome [3] 311494 0
The correlation between glycated albumin, HbA1c, fructosamine and 1,5-anhydroglucitol with continuous glucose monitoring indices of post-prandial glycaemic variability, including post-prandial glucose excursions (PPGE) and the post-prandial incremental area under the curve (iAUC).
Timepoint [3] 311494 0
14-18 weeks gestation, 24-28 weeks gestation, 32-36 weeks gestation
Secondary outcome [4] 311495 0
The correlation between glycated albumin, HbA1c, fructosamine and 1,5-anhydroglucitol with continuous glucose monitoring indices of glycaemic control including (a) the mean amplitude of glycaemic excursions (MAGE); (b) the largest amplitude of the glycaemic excursions (LAGE); (c) the standard deviation of blood glucose; and (d) the M value defined as the mean value of the statistic values of all deviations in blood glucose values with respect to the patients' target blood glucose values.
Timepoint [4] 311495 0
14-18 weeks gestation, 24-28 weeks gestation, 32-36 weeks gestation

Eligibility
Key inclusion criteria
- Type 1 diabetes mellitus
- 11-18 weeks of gestation
- Aged > 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe renal impairment - > stage 3 chronic kidney disease
- Severe hepatic derangement - AST > 3 times upper limit of normal and/or ALT > 3 times upper limit of normal

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Due to the low freqeuncy of type 1 diabetes in pregnancy, a conservative study number of n = 20 was chosen. It is hoped that the results of this study will inform larger clinical study designs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2014
Actual
25/07/2014
Date of last participant enrolment
Anticipated
Actual
11/04/2017
Date of last data collection
Anticipated
Actual
11/09/2017
Sample size
Target
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3164 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 8953 0
2065 - Royal North Shore Hospital

Funding & Sponsors
Funding source category [1] 290277 0
Commercial sector/Industry
Name [1] 290277 0
Novo Nordisk
Country [1] 290277 0
Australia
Funding source category [2] 300373 0
Charities/Societies/Foundations
Name [2] 300373 0
Ramsay Research and Teaching Fund
Country [2] 300373 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Building 51,
Royal North Shore Hospital Campus,
Reserve Road,
St Leonards,
NSW 2065
Country
Australia
Secondary sponsor category [1] 288987 0
None
Name [1] 288987 0
Address [1] 288987 0
Country [1] 288987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291975 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 291975 0
Research Office,
Kolling Building, Level 13,
Royal North Shore Hospital,
Reserve Road,
St Leonards,
NSW 2065
Ethics committee country [1] 291975 0
Australia
Date submitted for ethics approval [1] 291975 0
Approval date [1] 291975 0
12/05/2014
Ethics approval number [1] 291975 0
LNR/14/HAWKE/123

Summary
Brief summary
Macrosomia remains a common and important complication of type 1 diabetes in pregnancy, with adverse consequences for both mother and neonate. Accurate determination of glycaemic control remains difficult due to limitations in the accuracy of indices of glycaemic control in pregnancy and ongoing controversy regarding the timing of self-monitoring of blood glucose. Continuous glucose monitoring provides accurate glycaemic data but is limited due to cost and availability. Furthermore its use has not consistently shown improvements in pregnancy outcome. We hypothesise that glycated albumin will be a useful clinical tool for monitoring glycaemic control in pregnancy and with the availability of a new automated assay, has the potential to be widely accessable and cost effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52902 0
Dr Samantha Hocking
Address 52902 0
Department of Diabetes, Endocrinology & Metabolism,
Level 3, Acute Services Building,
Royal North Shore Hospital,
Reserve Road,
St Leonards,
NSW 2065
Country 52902 0
Australia
Phone 52902 0
+61 2 9463 1680
Fax 52902 0
Email 52902 0
[email protected]
Contact person for public queries
Name 52903 0
A/Prof Samantha Hocking
Address 52903 0
Central Clinical School and The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Faculty of Medicine and Health
Level 5 Charles Perkins Centre D17
The University of Sydney NSW 2006
Country 52903 0
Australia
Phone 52903 0
+61 2 8627 5086
Fax 52903 0
Email 52903 0
[email protected]
Contact person for scientific queries
Name 52904 0
A/Prof Samantha Hocking
Address 52904 0
Central Clinical School and The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Faculty of Medicine and Health
Level 5 Charles Perkins Centre D17
The University of Sydney NSW 2006
Country 52904 0
Australia
Phone 52904 0
+61 2 8627 5086
Fax 52904 0
Email 52904 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

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