Gestational Diabetes Clinical Trial
Official title:
Glucose Fluctuations During Gestation: an Additional Tool for a Better Monitoring of Pregnancy Complicated by Diabetes
Verified date | June 2013 |
Source | University of Padova |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: National Bioethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 2005 |
Est. primary completion date | March 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
University of Padova |
Italy,
Dalfrà 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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose variability indexes during first, second and third trimester of pregnancy | 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. | 9 months | No |
Secondary | Association between HbA1c and glucose variability indicators in the three trimesters pf pregnancy, in the three groups of women | 9 months | No |
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