Diabetes, GestationalPhase 1/2NCT00850135
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
A Phase 1/2 study testing The Seven Continuous Glucose Monitoring System in people with Diabetes, Gestational, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- The Seven Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Sep 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients
- Age 18-50
- Gestational age less than 28 weeks
Who cannot join
- Minors less than 18 years of age
- Multiple gestation
- Known fetal anomalies
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Santa Clara Valley Medical Center
San Jose, California, 95128
Stanford University School of Medicine
Stanford, California, 94305
About this study
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 determine which one correlates better with adverse pregnancy outcomes as well as which one more accurately identifies patients at risk for adverse pregnancy outcomes.
Read the 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 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. 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 pregnancy. The patient will be treated routinely, based on the results of the routine glucola test.
- Conditions
- Diabetes, Gestational
- Being tested
- The Seven Continuous Glucose Monitoring System
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Seven Continuous Glucose Monitoring SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitor in pregnancy | Other | 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. Receives: Device: The Seven Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Glucose AUC and Birth Weight.
For each patient's CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values "AUC-110," "AUC-120," "AUC-130," "AUC-140," and "AUC-180," and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result.
Measured: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
Secondary outcomes (1)
Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000
For our secondary outcome analyses,we chose to focus on AUC-130 because 130 mg/dL is a common threshold used when treating gestational diabetics. In addition, 130 mg/dL was the threshold used in an earlier pilot study performed at our institution because it had the best correlation with birth weight percentile.
Secondary outcomes were compared between these two groups using the chi-square test. Data were analyzed using Stata 11.2. AUC-130 values were divided into "high" and "low" at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
Measured: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Yasser Yehia El-Sayed, Stanford University
- Investigators
- Yasser Yehia El-Sayed, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850135
- Sponsor's protocol ID
- SU-02052009-1738
- Other IDs
- IRB #12335
- Status last verified
- Apr 2016
- First submitted
- 20 Feb 2009
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sung JF, Kogut EA, Lee HC, Mannan JL, Navabi K, Taslimi MM, El-Sayed YY. Correlation of continuous glucose monitoring profiles with pregnancy outcomes in nondiabetic women. Am J Perinatol. 2015 Apr;32(5):461-8. doi: 10.1055/s-0034-1390344. Epub 2014 Sep 28.
PubMed 25262455
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT00850135
- Acronym / sponsor ID
- SU-02052009-1738
- Conditions
- Diabetes, Gestational
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- Feb 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Posted 19 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 determine 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 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. 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 pregnancy. The patient will be treated routinely, based on the results of the routine glucola test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitor in pregnancy | Other | Device: The Seven Continuous Glucose Monitoring SystemThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant patients
- Age 18-50
- Gestational age less than 28 weeks
Key exclusion criteria (3 listed)
- Minors less than 18 years of age
- Multiple gestation
- Known fetal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Seven Continuous Glucose Monitoring SystemBetween 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. | Device | Continuous Glucose Monitor in pregnancy |
Primary outcome
Correlation Between Glucose AUC and Birth Weight.
Time frame: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
For each patient's CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values "AUC-110," "AUC-120," "AUC-130," "AUC-140," and "AUC-180," and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25262455Sung JF, Kogut EA, Lee HC, Mannan JL, Navabi K, Taslimi MM, El-Sayed YY. Correlation of continuous glucose monitoring profiles with pregnancy outcomes in nondiabetic women. Am J Perinatol. 2015 Apr;32(5):461-8. doi: 10.1055/s-0034-1390344. Epub 2014 Sep 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Yehia El-Sayed principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing The Seven Continuous Glucose Monitoring System in people with Diabetes, Gestational, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Glucose AUC and Birth Weight. (time frame: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00850135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.