Glucose Variability

Glucose Variability Clinical Trial

Official title:

Does Plasma Glucose Variability in Obese Diabetic Pregnancies Influence Maternal or Neonatal Outcomes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028259
• Other study ID #: 24669
• Status: Completed
• Start date: June 5, 2014
• Est. completion date: June 24, 2014

Study information

• Verified date: May 2018
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital, typically up to 1 week after deliver) will be conducted. These women are of any age and all ethnic backgrounds delivering at St. Mary's Health Center.

Description:

Maternal glucose control is considered to be a major determinant of neonatal outcome in pregnancies complicated by diabetes. Studies have examined the link between neonatal mortality and morbidity using specific mean preprandial or postprandial plasma glucose levels, however, have not taken into account the daily wide excursions that occur in maternal glucose levels. Limited data are available on glucose variability (GV) in pregnancy and affect on maternal or neonatal outcomes. A recent study amongst diabetics showed that glucose variability between two data points, a morning fasting blood glucose and an afternoon blood glucose, increased the rate of adverse neonatal outcomes1. Glycosylated hemoglobin (A1c), which has been considered the "gold standard" for diabetes control since the Diabetes Control and Complication Trial (DCCT)2, lacks the specificity to predict pregnancy outcomes. Through review of data, we propose to examine other methods of evaluating daily maternal glucose variations to determine the correlation to maternal and neonatal outcomes.

The objective of this study is to determine the effect of glucose variability and/ or other elements on maternal and neonatal outcomes in the obese diabetic patient. We hypothesize that glucose variability will be a stronger indicator of neonatal outcome than A1c or any single given blood glucose value. Glucose variability, including the magnitude of hyperglycemia or the incidence of acute maternal hypo- or hyperglycemic events, will be explored. We hypothesise that obese pregnant women with higher magnitude of glucose fluctuations have more maternal and fetal co morbidities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 24, 2014
• Est. primary completion date: June 24, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women with diabetes in pregnancy of any age, any ethnic background who deliver at St. Mary's Health Center, 1/1/2000 to 5/18/2014.

Exclusion Criteria:

• Data collected ager 5/18/2014

Related Conditions & MeSH terms

• Glucose Variability

Intervention

Other:
• lab results
Comparison of lab results

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose levels	the effect of glucose variability on maternal and neonatal outcomes in the obese diabetic patient.	1 year