Trial Outcomes & Findings for Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy (NCT NCT01165775)

NCT ID: NCT01165775

Last Updated: 2016-09-16

Results Overview

During a 24 hour monitoring period (24-48 hours post betamethasone treatment), which percentage of the time was spent above glucose thresholds (\>110;\>144;\>180)

• Recruitment status: COMPLETED
• Target enrollment: 17 participants
• Primary outcome timeframe: 24-48 hours post betamethasone treatment
• Results posted on: 2016-09-16

Participant Flow

Women receiving clinically indicated betamethasone between 24 and 34 weeks of pregnancy were recruited from the labor and delivery setting.

Participant milestones

Measure	Threatened Pre Term Labor Patients Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System. Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

Baseline characteristics by cohort

Measure	Threatened Pre Term Labor Patients n=15 Participants Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System. Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter. Data are available for 15 of 17 participants.
Age, Continuous	30 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 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	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Gestational age at enrollment	29.29 weeks n=5 Participants

PRIMARY outcome

Timeframe: 24-48 hours post betamethasone treatment

Population: Seventeen women were enrolled at the time of betamethasone administration and data were available for 15 patients.

During a 24 hour monitoring period (24-48 hours post betamethasone treatment), which percentage of the time was spent above glucose thresholds (>110;>144;>180)

Outcome measures

Measure	Non-Diabetic Threatened Pre Term Labor Patients n=11 Participants Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System. Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.	Diabetic Threatened Pre Term Labor Patients n=4 Participants Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System. Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.	Neonates With Unknown Hypoglycemia Status Neonates with unknown hypoglycemia status from birth to hospital discharge.
Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment mean (SD)% time with blood glucose > 110	73 percentage time Standard Deviation 6	79 percentage time Standard Deviation 20	—
Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment mean (SD)% time with blood glucose > 144	40 percentage time Standard Deviation 17	58 percentage time Standard Deviation 26	—
Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment mean (SD)% time with blood glucose > 180	17 percentage time Standard Deviation 13	24 percentage time Standard Deviation 13	—

SECONDARY outcome

Timeframe: birth to discharge

Population: Neonates from birth to discharge. The maternal patients received betamethasone to minimize the complications of prematurity. Maternal blood glucose levels were monitored using the Dexcom Seven Plus Continuous Glucose Monitoring System.

Outcome measures

Measure	Non-Diabetic Threatened Pre Term Labor Patients n=4 Participants Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System. Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.	Diabetic Threatened Pre Term Labor Patients n=6 Participants Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System. Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.	Neonates With Unknown Hypoglycemia Status n=5 Participants Neonates with unknown hypoglycemia status from birth to hospital discharge.
Neonatal Hypoglycemia Maternal Diabetes	2 participants	2 participants	0 participants
Neonatal Hypoglycemia No Maternal Diabetes	2 participants	4 participants	5 participants

Adverse Events

Threatened Pre Term Labor Patients

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 School of Medicine

Phone: (650) 723-3198

Email: Yasser.el-sayed@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place