Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes (GLIMPSE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Women and Infants Hospital of Rhode Island
Sponsor:
Information provided by (Responsible Party):
Hector Mendez-Figueroa, M.D., Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01818557
First received: March 21, 2013
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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 Intervention
Gestational Diabetes
Behavioral: Blood glucose testing

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 286
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)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • Patiets 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818557

Contacts
Contact: Hector Mendez-Figueroa, M.D. 401-274-1122 ext 7456 HMendezfigueroa@wihri.org

Locations
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.         
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Hector Mendez-Figueroa, M.D. Women & Infants Hospital
  More Information

No publications provided

Responsible Party: Hector Mendez-Figueroa, M.D., Clinical Fellow Division Maternal Fetal Medicine, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01818557     History of Changes
Other Study ID Numbers: GLIMPSE-033
Study First Received: March 21, 2013
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Women and Infants Hospital of Rhode Island:
glucose monitoring
gestational diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on August 25, 2014