![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | February 20, 2009 | ||||
Last Updated Date | February 20, 2009 | ||||
Start Date † | February 2009 | ||||
Current Primary Outcome Measures † |
Birth weight centile | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
Unplanned operative deliveries | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes | ||||
Official Title † | Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes | ||||
Brief Summary | Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels. the one-hour glucola test is currently used to screen pregnant patients for gestational diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour later. We wish to compare 7-day continuous glucose monitoring to the one-hour glucola test, and detremine which one correlates better with adverse pregnancy outcomes as well as which one more accurately identifies patients at risk for adverse pregnancy outcomes. |
||||
Detailed Description | All pregnant patients without pre-existing diabetes will be eligible for the study. Interest in participation will be determined at their initial prenatal visit. Those that are interested will be consented. 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 aptient 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. She will perform the routine glucola test sometime between days 2 to 7 . Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS. Results of CGMS will not be available to the patient or her physician until after completion of the paregnancy. The patient will be treated routinely, based on the results of the routine glucola test. |
||||
Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
Condition † | Diabetes, Gestational | ||||
Intervention † | Device: The Seven Continuous Glucose Monitoring System | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 230 | ||||
Completion Date | |||||
Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:-Pregnant patients with no diagnosis of pre-existing diabetes
Exclusion Criteria:-Minors less than 18 years of age
|
||||
Gender | Female | ||||
Ages | 18 Years to 50 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
|
||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00850135 | ||||
Responsible Party | Sung Joyce, M.D. | ||||
Secondary IDs †† | IRB #12335 | ||||
Study Sponsor † | Stanford University | ||||
Collaborators †† | DexCom, Inc. | ||||
Investigators † |
|
||||
Information Provided By | Stanford University | ||||
Verification Date | February 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |