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Glucose Variability

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03028259
Enrollment
161
Registered
2017-01-23
Start date
2014-06-05
Completion date
2014-06-24
Last updated
2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Variability

Brief 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.

Detailed 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.

Interventions

OTHERlab results

Comparison of lab results

Sponsors

St. Louis University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
glucose levels1 yearthe effect of glucose variability on maternal and neonatal outcomes in the obese diabetic patient.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026