Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes (GLIMPSE)
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?
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes: A Randomized, Non-Inferiority Pilot Study|
- Neonatal weight [ Time Frame: At birth ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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.
This study is a prospective randomized, non-inferiority clinical trial of pregnant women diagnosed with gestational diabetes and cared for at the Diabetes in Pregnancy clinic in Women & Infants Hospital in Providence, Rhode Island. 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818557
|Contact: Hector Mendez-Figueroa, M.D.||401-274-1122 ext 7456||HMendezfigueroa@wihri.org|
|United States, Rhode Island|
|Women & Infants Hospital||Recruiting|
|Providence, Rhode Island, United States, 02905|
|Contact: Hector Mendez-Figueroa, M.D. 401-274-1122 ext 7456 HMendezfigueroa@wihri.org|
|Principal Investigator: Hector Mendez-Figueroa, M.D.|
|Principal Investigator:||Hector Mendez-Figueroa, M.D.||Women & Infants Hospital|