Glucose Variability in Pregnancy Complicated by Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Continuous Glucose Monitoring Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Glycemic Variability Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Florence, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

Association between HbA1c and glucose variability indicators in the three trimesters pf pregnancy, in the three groups of women

Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Glucose Fluctuations During Gestation: an Additional Tool for a Better Monitoring of Pregnancy Complicated by Diabetes

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Jun 21, 2013
Registry last updated: Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed