Glucose Variability in Pregnancy Complicated by Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Padova
ClinicalTrials.gov Identifier:
NCT01883622
First received: June 18, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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
Gestational Diabetes
Continuous Glucose Monitoring
Glycemic Variability

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Glucose Fluctuations During Gestation: an Additional Tool for a Better Monitoring of Pregnancy Complicated by Diabetes

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • Glucose variability indexes during first, second and third trimester of pregnancy [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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:
  • Association between HbA1c and glucose variability indicators in the three trimesters pf pregnancy, in the three groups of women [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type 1 diabetes
Pregnant women affected by type 1 diabetes mellitus
GDM
Pregnant women affected by gestational diabetes mellitus
Healthy
Healthy pregnant women

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883622

Locations
Italy
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
Investigators
Study Chair: Annunziata Lapolla, MD Department of Medicine, University of Padova
  More Information

Publications:
Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01883622     History of Changes
Other Study ID Numbers: GES03
Study First Received: June 18, 2013
Last Updated: June 18, 2013
Health Authority: Italy: National Bioethics Committee

Keywords provided by University of Padova:
diabetes
pregnancy
glucose variability
continuous glucose monitoring (CGM)
gestational diabetes mellitus (GDM)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on July 22, 2014