Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes

NCT01818557 | Completed

• 1 other identifier: HSC-MS-13-0719
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 3

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?

Conditions

Gestational Diabetes

Keywords

glucose monitoring; gestational diabetes

Outcome Measures

Primary Outcomes (1)

• 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

  At birth

Secondary Outcomes (1)

• Macrosomia

  At birth

Study Arms (2)

Every day blood glucose testing

NO INTERVENTION

Patients will test their blood glucose values 4 times every day

Every other day blood glucose testing

EXPERIMENTAL

Patients will test their blood glucose 4 times every other day

Behavioral: Blood glucose testing

Interventions

Blood glucose testing BEHAVIORAL

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.

Every other day blood glucose testing

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Women and Infants Hospital of Rhode Island: collaborator
• Geisinger Clinic: collaborator

Study Sites (3)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

The University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 28594772 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Blood Glucose

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Hector Mendez-Figueroa, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

US (3)