Intensive Management for Gestational Diabetes (GDM-MOMS)

Randomized Controlled Clinical Pilot Trial of Intensive Management for Gestational Diabetes

This is a randomized clinical pilot trial designed to assess the feasibility of randomizing obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration will also be compared between groups.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Lower glycemic targets

Detailed Description

The investigators will randomize 60 obese pregnant women with a new diagnosis of gestational diabetes using the Carpenter-Coustan criteria in a 1:1 fashion to either standard care or intensive therapy. Subjects will be randomized to either standard care or intensive therapy at the first study visit, which will occur between 12-32 weeks of gestation after they have completed their gestational diabetes testing. Neither patients nor their providers will be blinded to patient study group. All women will receive standard nutritional counseling at the time of diagnosis, and they will also be treated with either glyburide or insulin as dictated by standard care. Women will return for a second study visit between 32-36 weeks of gestation to assess the impact of their glycemic target groups on overall glycemic control. The investigators will also collect information on the type and dose of each medication required to maintain glycemic control in women randomized to either standard care or intensive therapy.

In addition to standard glucose monitoring 4x/day (fasting and one-hour post breakfast, lunch, and dinner), the investigators will utilize blinded continuous glucose monitors (iPro, Medtronic) at each study visit. Because women with GDM are receiving active management of their blood sugars and dietary counseling, the investigators will assess CGM for 5 consecutive days both at study enrollment and again between 32-36 weeks. Study participants will complete food diaries during their CGM monitoring to correlate food intake with glycemic variation. The investigators will also compare maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration between groups.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• maternal age between 18-45 years
• singleton birth
• planned delivery at OU Medical Center
• GDM diagnosed between 12-32 weeks' gestation by either a 50 gram
• one hour GCT >200 mg/dL or two or more abnormal values on a 100 gram OGTT using the Carpenter-Coustan criteria
• pre-pregnancy BMI ≥26 kg/m2.

Exclusion Criteria:

• maternal tobacco use
• planned delivery prior to 34 weeks of gestation
• significant fetal anomalies
• chronic hypertension requiring medication
• other vascular disease
• known renal disease with a baseline serum creatinine >1.5 mg/dL
• maternal rheumatologic disorders requiring medication
• maternal human immunodeficiency virus (HIV) or hepatitis
• as the specimen storage facility is not accredited to handle such samples
• steroid use within 7 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard care; Women in this arm will target fasting blood glucose values <95 mg/dL and 1 hour post-prandial values <140 mg/dL	Other: Lower glycemic targets; Women will be randomized to either standard or lower glycemic targets.
EXPERIMENTAL: Intensive therapy; Women in the arm will target fasting blood glucose values <90 mg/dL and 1 hour post-prandial values <120 mg/dL.	Other: Lower glycemic targets; Women will be randomized to either standard or lower glycemic targets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline maternal glycemia at 32-36 weeks gestation	Women will undergo CGM for 5 days at both the first study visit (12-32 weeks) and again at the second study visit (32-36 weeks). Our primary outcome between women randomized to either SC or IT will compare mean 24-hour blood glucose levels as assessed by continuous glucose monitor at the 2nd study visit, which will occur between 32-36 weeks of gestation. Investigators hypothesize that women randomized to the IT group will have a 10 mg/dL lower mean 24-hour glucose as assessed by continuous glucose monitor when compared to women in the SC group. Investigators will also assess the prevalence of maternal hypoglycemia by comparing the amount of time with maternal blood glucose values <60 mg/dL between groups.	5 days at 2 separate times (1st study visit at 12-32 weeks, 2nd study visit at 32-36 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal body composition	Total body composition will compared among infants of mothers randomized to either SC and IT using air-displacement plethysmography (ADP).	At birth
Cytokine measurements	Maternal and cord blood levels	20-30 weeks of gestation and 32-36 weeks of gestation
Physical activity	Investigators will utilize the Actiwatch Spectrum Pro (Phillips Healthcare, Pittsburgh, PA) for assessment of both sleep and physical activity in women . Subjects will wear this device on their wrist at baseline and again at the 32-36 week follow-up visit. The Actiwatch monitoring periods are designed to coincide with the periods of CGM monitoring.	9 months
Sleep assessments	Investigators will utilize the Actiwatch Spectrum Pro (Phillips Healthcare, Pittsburgh, PA) for assessment of both sleep and physical activity in women . Subjects will wear this device on their wrist at baseline and again at the 32-36 week follow-up visit. The Actiwatch monitoring periods are designed to coincide with the periods of CGM monitoring.	9 months
Patient questionnaires	In order to help investigators understand the personal factors that lead to better glycemic control, patients will complete questionnaires regarding issues such as sleep, exercise, views about weight gain, mood, and stress levels.	9 months
Lipid measurements		20-30 weeks of gestation and 32-36 weeks of gestation
Glucose measurements		20-30 weeks of gestation and 32-36 weeks of gestation
Lipid profile measurements		20-30 weeks of gestation and 32-36 weeks of gestation

Collaborators and Investigators

• Sponsor: University of Oklahoma

Publications and helpful links

General Publications

• Scifres CM, Mead-Harvey C, Nadeau H, Reid S, Pierce S, Feghali M, Myers D, Fields D, Stoner JA. Intensive glycemic control in gestational diabetes mellitus: a randomized controlled clinical feasibility trial. Am J Obstet Gynecol MFM. 2019 Nov;1(4):100050. doi: 10.1016/j.ajogmf.2019.100050. Epub 2019 Sep 27.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (ESTIMATE): August 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 5446