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The Clinical Utility of Glycated Albumin as an Index of Glycaemic Control in Type 1 Diabetic Pregnancy and its ability to predict Neonatal Outcome

The Clinical Utility of Glycated Albumin as an Index of Glycaemic Control in Type 1 Diabetic Pregnancy and its ability to predict Neonatal Outcome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614001295639
Acronym
Glycated Albumin in Type 1 Diabetic Pregnancy
Enrollment
29
Registered
2014-12-11
Start date
2014-07-25
Completion date
2017-04-11
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Sponsors

Northern Sydney Local Health District
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Type 1 diabetes mellitus - 11-18 weeks of gestation - Aged > 18 years

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026