Trial Outcomes & Findings for Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes (NCT NCT00850135)

Last Updated: 2016-05-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

57 participants

Primary outcome timeframe

CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery

Results posted on

2016-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	57
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery

Population: A total of 57 patients were enrolled from two clinical sites. Two patients did not have monitoring or delivery data. Two patients who had an existing diagnosis of diabetes were excluded. The remaining 53 patients were analyzed.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor for Diabetes in Pregnancy Screening n=53 Participants 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.	Participants With AUC 130 >22,000 AUC-130 values were divided into"high" and "low" at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
Correlation Between Glucose AUC and Birth Weight. AUC-110 to birth weight centile	0.2902 correlation coefficient	—
Correlation Between Glucose AUC and Birth Weight. AUC-120 to birth weight centile	0.2935 correlation coefficient	—
Correlation Between Glucose AUC and Birth Weight. AUC-130 to birth weight centile	0.2915 correlation coefficient	—
Correlation Between Glucose AUC and Birth Weight. AUC-140 to birth weight centile	0.2859 correlation coefficient	—
Correlation Between Glucose AUC and Birth Weight. AUC-180 to birth weight centile	0.2499 correlation coefficient	—
Correlation Between Glucose AUC and Birth Weight. 1hr GCT to birth weight centile (n=44)	-0.0234 correlation coefficient	—

SECONDARY outcome

Timeframe: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery

Population: A total of 57 patients were enrolled from two clinical sites. Of these patients, 44 were screened with the 1-hour 50-g GCT; 9 were screened with 2-hour 75-g GTT. Complete data on secondary outcomes was available for 43 patients with 1-hour 50-g GCT and these were analyzed.

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.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor for Diabetes in Pregnancy Screening n=38 Participants 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.	Participants With AUC 130 >22,000 n=5 Participants AUC-130 values were divided into"high" and "low" at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000 Delivery Mode: Vaginal Delivery	31 participants	5 participants
Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000 Delivery Mode: Unplanned Operative Delivery	7 participants	0 participants
Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000 Macrosomia >90%	4 participants	1 participants

Adverse Events

Continuous Glucose Monitor for Diabetes in Pregnancy Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yasser El-Sayed, MD

Stanford University School of Medicine

Phone: (650) 723-3198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place