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

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood glucose testing
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gestational Diabetes focused on measuring glucose monitoring, gestational diabetes

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Geisinger Health System
  • Women & Infants Hospital
  • The University of Texas Health Science Center, Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Every day blood glucose testing

Every other day blood glucose testing

Arm Description

Patients will test their blood glucose values 4 times every day

Patients will test their blood glucose 4 times every other day

Outcomes

Primary Outcome Measures

Neonatal weight
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
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

Full Information

First Posted
March 21, 2013
Last Updated
June 28, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Women and Infants Hospital of Rhode Island, Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01818557
Brief Title
Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes
Acronym
GLIMPSE
Official Title
Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes: A Randomized, Non-Inferiority Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Women and Infants Hospital of Rhode Island, Geisinger Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
glucose monitoring, gestational diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Every day blood glucose testing
Arm Type
No Intervention
Arm Description
Patients will test their blood glucose values 4 times every day
Arm Title
Every other day blood glucose testing
Arm Type
Experimental
Arm Description
Patients will test their blood glucose 4 times every other day
Intervention Type
Behavioral
Intervention Name(s)
Blood glucose testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neonatal weight
Description
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
Time Frame
At birth
Secondary Outcome Measure Information:
Title
Macrosomia
Description
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
Time Frame
At birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector Mendez-Figueroa, M.D.
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Health System
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Women & Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
The University of Texas Health Science Center, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28594772
Citation
Mendez-Figueroa H, Schuster M, Maggio L, Pedroza C, Chauhan SP, Paglia MJ. Gestational Diabetes Mellitus and Frequency of Blood Glucose Monitoring: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):163-170. doi: 10.1097/AOG.0000000000002101.
Results Reference
derived

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Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes

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