Glucose Variability in Pregnancy Complicated by Diabetes

NCT ID: NCT01883622

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-03-31

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.

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.

Conditions

Gestational Diabetes; Continuous Glucose Monitoring; Glycemic Variability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Type 1 diabetes

Pregnant women affected by type 1 diabetes mellitus

No interventions assigned to this group

GDM

Pregnant women affected by gestational diabetes mellitus

No interventions assigned to this group

Healthy

Healthy pregnant women

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annunziata Lapolla, MD

Role: STUDY_CHAIR

Department of Medicine, University of Padova

Locations

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

Florence, , Italy

Department of Medicine, University of Padua

Padua, , Italy

Department of Endocrinology and Metabolic Diseases, University of Pisa

Pisa, , Italy

Countries

Italy

References

Dalfra MG, Sartore G, Di Cianni G, Mello G, Lencioni C, Ottanelli S, Sposato J, Valgimigli F, Scuffi C, Scalese M, Lapolla A. Glucose variability in diabetic pregnancy. Diabetes Technol Ther. 2011 Aug;13(8):853-9. doi: 10.1089/dia.2010.0145.

Reference Type: BACKGROUND

PMID: 21751862 (View on PubMed)

Kerssen A, de Valk HW, Visser GH. Forty-eight-hour first-trimester glucose profiles in women with type 1 diabetes mellitus: a report of three cases of congenital malformation. Prenat Diagn. 2006 Feb;26(2):123-7. doi: 10.1002/pd.1340.

Reference Type: BACKGROUND

PMID: 16463292 (View on PubMed)

Di Cianni G, Miccoli R, Volpe L, Lencioni C, Del Prato S. Intermediate metabolism in normal pregnancy and in gestational diabetes. Diabetes Metab Res Rev. 2003 Jul-Aug;19(4):259-70. doi: 10.1002/dmrr.390.

Reference Type: BACKGROUND

PMID: 12879403 (View on PubMed)

Other Identifiers

GES03

Identifier Type: -

Identifier Source: org_study_id