Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 7/4/2018 |
| Start Date: | May 2013 |
| End Date: | October 2016 |
Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes: A Randomized, Non-Inferiority Pilot Study
The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to
test their blood glucose at least four times daily. The investigators propose to
prospectively evaluate blood glucose testing done every day compared to every other day. The
primary goal is to establish the most cost-effective modality while still being able to
detect patients who require therapy in a timely fashion. The investigators plan to evaluate
this new management scheme utilizing a non-inferiority trial design.
The investigators primary research question is the following: When managing patients with
GDM, is every other day blood glucose testing non-inferior compared to every day blood
glucose testing, as measured by the difference of less than 5% in birth weight?
test their blood glucose at least four times daily. The investigators propose to
prospectively evaluate blood glucose testing done every day compared to every other day. The
primary goal is to establish the most cost-effective modality while still being able to
detect patients who require therapy in a timely fashion. The investigators plan to evaluate
this new management scheme utilizing a non-inferiority trial design.
The investigators primary research question is the following: When managing patients with
GDM, is every other day blood glucose testing non-inferior compared to every day blood
glucose testing, as measured by the difference of less than 5% in birth weight?
This study is a prospective randomized, non-inferiority clinical trial of pregnant women
diagnosed with gestational diabetes. Patients with GDM diagnosed between 20 weeks 0 days and
32 weeks 0 days of gestation will be recruited. Diagnosis of GDM will be based on Carpenter
and Coustan criteria for an abnormal 3-hr 100 gram oral glucose tolerance test, as currently
supported by the American College of Obstetricians and Gynecologists (ACOG). Patients whose
1-hr, 50 gram oral glucose challenge test exceeds 200 mg/dl will not require a 3-hr oral
glucose tolerance test (OGTT). If the patient meets the inclusion and exclusion criteria
listed below, she will be offered participation in the trial and randomized to every day
blood glucose testing or every other day blood glucose testing for the remainder of her
pregnancy.
After the diagnosis of GDM, and before recruitment to the study, all patients will be
provided counseling and education and will attempt adequate blood glucose control with
medical nutritional therapy alone for one week. During this period, all patients will test
their blood glucose values daily. Only after this week is completed will a subject be
approached for participation.
diagnosed with gestational diabetes. Patients with GDM diagnosed between 20 weeks 0 days and
32 weeks 0 days of gestation will be recruited. Diagnosis of GDM will be based on Carpenter
and Coustan criteria for an abnormal 3-hr 100 gram oral glucose tolerance test, as currently
supported by the American College of Obstetricians and Gynecologists (ACOG). Patients whose
1-hr, 50 gram oral glucose challenge test exceeds 200 mg/dl will not require a 3-hr oral
glucose tolerance test (OGTT). If the patient meets the inclusion and exclusion criteria
listed below, she will be offered participation in the trial and randomized to every day
blood glucose testing or every other day blood glucose testing for the remainder of her
pregnancy.
After the diagnosis of GDM, and before recruitment to the study, all patients will be
provided counseling and education and will attempt adequate blood glucose control with
medical nutritional therapy alone for one week. During this period, all patients will test
their blood glucose values daily. Only after this week is completed will a subject be
approached for participation.
Inclusion Criteria:
- Gestational age between 20 weeks 0 days and 32 weeks 0 days of gestation.
- Singleton pregnancies
- Maternal age over 18 years
- Patients able to read and write in English or Spanish,
- Diagnosis of gestational diabetes mellitus using criteria supported by the American
College of Obstetrics and Gynecology (ACOG).
- Patients identified as not requiring medical therapy (insulin or glyburide) after the
first week of initial blood glucose monitoring.
Exclusion Criteria:
- Diagnosis of GDM made by any method or criteria other than the one outlined above
- Women with pre-existing diabetes mellitus
- Patients under the age of 18 years
- Patients known to be carrying a fetus with a fetal anomaly that requires either
prenatal or postnatal surgery, requires early delivery or is at risk for intrauterine
growth restriction (IUGR)
- Patients carrying multiple gestations
- Patients with past history of gastric bypass
- Patients with poorly controlled asthma, defined as the need for oral/inhaled
corticosteroids to control symptoms
- Patients with chronic hypertension requiring medical therapy
- Patients currently on methadone/suboxone therapy
- Patients currently on any steroid therapy, regardless of the dose or route of
administration
- Patients demonstrating poor compliance during the first week of initial blood glucose
monitoring, defined as <20% of expected values actually recorded during the one-week
period of initial monitoring
We found this trial at
3
sites
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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