Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes

This study has been completed.
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier:
NCT00850135
First received: February 20, 2009
Last updated: April 13, 2016
Last verified: April 2016
Results First Received: April 13, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Diabetes, Gestational
Intervention: Device: The Seven Continuous Glucose Monitoring System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Continuous Glucose Monitor for Diabetes in Pregnancy Screening The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.

Participant Flow:   Overall Study
    Continuous Glucose Monitor for Diabetes in Pregnancy Screening  
STARTED     57  
COMPLETED     56  
NOT COMPLETED     1  
Physician Decision                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 57 patients were enrolled from two clinical sites. One patient had no CGM data. One patient transferred care after completing the CGM study period, and thus did not have delivery data. Two patients who had an existing diagnosis of diabetes were excluded.The remaining 53 patients were analyzed.

Reporting Groups
  Description
Continuous Glucose Monitor for Diabetes in Pregnancy Screening The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.

Baseline Measures
    Continuous Glucose Monitor for Diabetes in Pregnancy Screening  
Number of Participants  
[units: participants]
  53  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     53  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  30  (5)  
Gender  
[units: participants]
 
Female     53  
Male     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     24  
Not Hispanic or Latino     29  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     11  
Native Hawaiian or Other Pacific Islander     2  
Black or African American     0  
White     14  
More than one race     2  
Unknown or Not Reported     24  
Region of Enrollment  
[units: participants]
 
United States     53  
Gestational Age at Enrollment  
[units: weeks]
Mean (Standard Deviation)
  25.9  (1.2)  
Parity  
[units: participants]
 
Nulliparous     23  
Multiparous     30  
Pre-pregnancy BMI  
[units: kg/m2]
Mean (Standard Deviation)
  29.1  (8.4)  
BMI at enrollment  
[units: kg/m2]
Mean (Standard Deviation)
  32.5  (8.5)  
Insurance status  
[units: participants]
 
Public     29  
Private     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Correlation Between Glucose AUC and Birth Weight.   [ Time Frame: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery ]

2.  Secondary:   Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000   [ Time Frame: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limited monitoring period between 24 and 28 weeks’ gestation. Sample size was under powered to detect differences in secondary outcomes of interest.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Yasser El-Sayed, MD
Organization: Stanford University School of Medicine
phone: (650) 723-3198
e-mail: Yasser.el-sayed@stanford.edu


Publications of Results:

Responsible Party: Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier: NCT00850135     History of Changes
Other Study ID Numbers: SU-02052009-1738
IRB #12335 ( Other Identifier: Stanford University Medical Center IRB )
Study First Received: February 20, 2009
Results First Received: April 13, 2016
Last Updated: April 13, 2016
Health Authority: United States: Institutional Review Board