Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes (GLIMPSE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01818557|
Recruitment Status : Completed
First Posted : March 26, 2013
Last Update Posted : July 2, 2018
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?
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes||Behavioral: Blood glucose testing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||293 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes: A Randomized, Non-Inferiority Pilot Study|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
No Intervention: Every day blood glucose testing
Patients will test their blood glucose values 4 times every day
Experimental: Every other day blood glucose testing
Patients will test their blood glucose 4 times every other day
Behavioral: Blood glucose testing
Patients will be assigned either to blood glucose monitoring done every day (during a fasting state and 2 hours after breakfast, lunch and dinner) continued throughout gestation or to blood glucose monitoring done every other day with the same timeframes outlined above.
- Neonatal weight [ Time Frame: At birth ]In patients with GDM, every other day blood glucose testing is non-inferior to every day blood glucose testing, as measured by the difference of less than 5% in birth weight
- Macrosomia [ Time Frame: At birth ]To determine if every other day testing is associated with a greater rate of macrosomia, defined as birth weight > 4,000 grams, than every day blood glucose testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818557
|United States, Pennsylvania|
|Geisinger Health System|
|Danville, Pennsylvania, United States, 17822|
|United States, Rhode Island|
|Women & Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|United States, Texas|
|The University of Texas Health Science Center, Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hector Mendez-Figueroa, M.D.||The University of Texas Health Science Center, Houston|