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Glucose Variability in Pregnancy Complicated by Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01883622
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Information provided by (Responsible Party):
University of Padova

Brief Summary:
Continuous glucose monitoring (CGM) methods provide details of magnitude and duration of glucose fluctuations, giving a unique insight on daily blood sugar control. Limited data are available on glucose variability (GV) in pregnancy. The aim of this study was to assess GV in normal pregnant women and cases of type 1 diabetes mellitus or gestational diabetes (GDM), and its possible association with HbA1c.

Condition or disease
Gestational Diabetes Continuous Glucose Monitoring Glycemic Variability

Detailed Description:

Recent evidence in the literature suggests that glucose variability, characterized by extreme glucose excursions, may overlap with HbA1c levels in determining the risk of diabetes-related complications. Fluctuating blood glucose levels prompt an increase in free radicals and endothelial dysfunction, which are the links between hyperglycemia and the activation of pathological pathways that lead to tissue damage. Reece and Homko postulated an association between maternal hyperglycemia-induced oxygen free radical overproduction and fetal abnormalities, with the onset of diabetes-related embryopathy.Numerous studies have demonstrated that macrosomia and congenital malformations relate to glycemic control. In one study, 48-hour continuous glucose monitoring (CGM) of diurnal glucose profiles in pregnant women with type 1 diabetes was more sensitive than HbA1c alone in identifying an increased risk of offspring with congenital malformations. Such studies give the impression that transient hyperglycemic spikes in pregnant patients with diabetes can cause a high incidence of fetal overweight, regardless of whether or not the mother has chronic hyperglycemia. Glucose variability is still a factor that has been inadequately studied in pregnancies complicated by diabetes, and little is known about its relationship with maternal-fetal outcomes.A number of studies have demonstrated the utility of CGM for monitoring diabetes in pregnancy , but none have focused the attention on the importance of glucose fluctuations during gestation. Meanwhile, there has been a rapid increase in the number of new glucose variability indicators considered, although none of them seems to be definitively reliable.

A better understanding of the pattern of blood glucose fluctuations in all the three trimesters of pregnancy, could help us to optimize glycemic control in pregnant women with diabetes.

The aim of this study was therefore to assess glucose variability throughout the three trimesters of pregnancy in healthy women and in cases of type 1 diabetes mellitus or gestational diabetes, identifying the more representative and useful indicators of glucose fluctuations, to provide more accurate clinical informations along with HbA1c and beyond.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Glucose Fluctuations During Gestation: an Additional Tool for a Better Monitoring of Pregnancy Complicated by Diabetes
Study Start Date : January 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Type 1 diabetes
Pregnant women affected by type 1 diabetes mellitus
Pregnant women affected by gestational diabetes mellitus
Healthy pregnant women

Primary Outcome Measures :
  1. Glucose variability indexes during first, second and third trimester of pregnancy [ Time Frame: 9 months ]
    Patients wore underwent continuous glucose monitoring for 2 days in each trimester of pregnancy. As indexes of glucose variability we considered: the mean amplitude of glucose excursion (MAGE); the total standard deviation (SD); the interquartile range (IQR); the continuous overlapping net glycemic action (CONGA1), calculated at 1 hour. The low blood glucose index (LBGI) and high blood glucose index (HBGI) were also calculated.

Secondary Outcome Measures :
  1. Association between HbA1c and glucose variability indicators in the three trimesters pf pregnancy, in the three groups of women [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient pregnant women enrolled at three Italian diabetes clinics (Padua, Pisa and Florence)

Inclusion Criteria:

  • diagnosis of type 1 diabetes or GDM
  • able to become familiar with glucose monitoring methodologies

Exclusion Criteria:

  • type 2 diabetes
  • pre-gestational BMI > 35 Kg/m2
  • HbA1c > 8% for type 1 diabetic pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01883622

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Department of Gynecology, Perinatology and Human Reproduction, University of Florence
Florence, Italy
Department of Medicine, University of Padua
Padova, Italy
Department of Endocrinology and Metabolic Diseases, University of Pisa
Pisa, Italy
Sponsors and Collaborators
University of Padova
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Study Chair: Annunziata Lapolla, MD Department of Medicine, University of Padova
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Responsible Party: University of Padova Identifier: NCT01883622    
Other Study ID Numbers: GES03
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by University of Padova:
glucose variability
continuous glucose monitoring (CGM)
gestational diabetes mellitus (GDM)
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications