WithdrawnPhase 2ACTRN12614001250628

Glucose Targets in gestational diabetes Pilot

An evaluation of the safety of very tight glycaemic control versus tight glycaemic control in women with gestational diabetes


Sponsor

Women's and Children's Hospital

Enrollment

40 participants

Start Date

Dec 4, 2014

Study Type

Interventional

Conditions

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


Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria1

  • 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

Exclusion Criteria1

  • >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)

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Interventions

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

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


Locations(1)

Womens and Childrens Hospital - North Adelaide

SA, Australia

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ACTRN12614001250628


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