Trial Outcomes & Findings for Postpartum Continuous Glucose Monitoring (CGM) Study (NCT NCT05714761)
NCT ID: NCT05714761
Last Updated: 2025-03-20
Results Overview
Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.
COMPLETED
NA
50 participants
Postpartum days 10-20
2025-03-20
Participant Flow
Recruitment was conducted from February 2023-January 2024 at a single urban medical center.
Participant milestones
| Measure |
Postpartum Glucose Sensor
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
CGM Returned
|
43
|
|
Overall Study
Completed Routine Postpartum Oral Glucose Tolerance Test (OGTT)
|
34
|
|
Overall Study
Returned the Second CGM Sensor
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Postpartum Glucose Sensor
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
unblinding of sensor data
|
1
|
|
Overall Study
did not complete routine postpartum OGTT
|
9
|
|
Overall Study
did not return second CGM sensor
|
4
|
Baseline Characteristics
Postpartum Continuous Glucose Monitoring (CGM) Study
Baseline characteristics by cohort
| Measure |
Postpartum Glucose Sensor
n=50 Participants
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
20 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=99 Participants
|
|
Pre-pregnancy body mass index
|
26.6 kg/m^2
n=99 Participants
|
|
Insurance type
Commercial
|
33 Participants
n=99 Participants
|
|
Insurance type
Medicaid
|
17 Participants
n=99 Participants
|
|
Education Level
Some high school or less
|
7 Participants
n=99 Participants
|
|
Education Level
High school/GED
|
3 Participants
n=99 Participants
|
|
Education Level
Some college
|
8 Participants
n=99 Participants
|
|
Education Level
College degree
|
16 Participants
n=99 Participants
|
|
Education Level
Post college
|
14 Participants
n=99 Participants
|
|
Education Level
Prefer not to answer
|
2 Participants
n=99 Participants
|
|
Family history of type 2 diabetes
|
30 Participants
n=99 Participants
|
|
Multigravida
|
39 Participants
n=99 Participants
|
|
Gestational diabetes (GDM) in prior pregnancy
|
13 Participants
n=99 Participants
|
|
Number of prenatal visits
|
13.8 visits
STANDARD_DEVIATION 4.6 • n=99 Participants
|
|
GDM management
Diet/Lifestyle only
|
23 Participants
n=99 Participants
|
|
GDM management
Oral agents
|
4 Participants
n=99 Participants
|
|
GDM management
Insulin
|
23 Participants
n=99 Participants
|
|
Hypertensive complications
|
11 Participants
n=99 Participants
|
|
Delivery type
Vaginal
|
33 Participants
n=99 Participants
|
|
Delivery type
C-section
|
17 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Postpartum days 10-20Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.
Outcome measures
| Measure |
Postpartum Glucose Sensor
n=50 Participants
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
Second Sensor
Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days at time of glucose tolerance test. Data collected for 4-12 weeks postpartum.
|
|---|---|---|
|
Number of Participants With at Least 72 Hours of CGM Data Downloaded.
|
43 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 12 weeks postpartumPopulation: Results for usable data
Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition. Specificity for Time in Range 70-180 mg/dL of \<96% for abnormal OGTT is reported.
Outcome measures
| Measure |
Postpartum Glucose Sensor
n=34 Participants
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
Second Sensor
n=29 Participants
Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days at time of glucose tolerance test. Data collected for 4-12 weeks postpartum.
|
|---|---|---|
|
Specificity
|
78 percent
|
83.33 percent
|
SECONDARY outcome
Timeframe: up to 12 weeks postpartumPopulation: Results for usable data
Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases. Sensitivity for Time in Range 70-180 mg/dL of \<96% for abnormal OGTT is reported.
Outcome measures
| Measure |
Postpartum Glucose Sensor
n=34 Participants
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
Second Sensor
n=29 Participants
Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days at time of glucose tolerance test. Data collected for 4-12 weeks postpartum.
|
|---|---|---|
|
Sensitivity
|
100 percent
|
66.67 percent
|
SECONDARY outcome
Timeframe: up to 12 weeks postpartumPPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease. Positive predictive value (PPV) of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported.
Outcome measures
| Measure |
Postpartum Glucose Sensor
n=43 Participants
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
Second Sensor
n=30 Participants
Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days at time of glucose tolerance test. Data collected for 4-12 weeks postpartum.
|
|---|---|---|
|
Positive Predictive Value (PPV)
|
53.49 percent
|
50 percent
|
SECONDARY outcome
Timeframe: up to 12 weeks postpartumPLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition. PLR of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported.
Outcome measures
| Measure |
Postpartum Glucose Sensor
n=43 Participants
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
Second Sensor
n=30 Participants
Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days at time of glucose tolerance test. Data collected for 4-12 weeks postpartum.
|
|---|---|---|
|
Positive Likelihood Ratio (PLR)
|
4.5 ratio
|
3.83 ratio
|
SECONDARY outcome
Timeframe: up to 12 weeks postpartumNPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease. NPV of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported.
Outcome measures
| Measure |
Postpartum Glucose Sensor
n=43 Participants
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
Second Sensor
n=30 Participants
Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days at time of glucose tolerance test. Data collected for 4-12 weeks postpartum.
|
|---|---|---|
|
Negative Predictive Value (NPV)
|
100 percent
|
90 percent
|
SECONDARY outcome
Timeframe: up to 12 weeks postpartumNLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition. NLR of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported.
Outcome measures
| Measure |
Postpartum Glucose Sensor
n=43 Participants
Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test.
Dexcom glucose sensor: Use of a Dexcom G6 Pro
|
Second Sensor
n=30 Participants
Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days at time of glucose tolerance test. Data collected for 4-12 weeks postpartum.
|
|---|---|---|
|
Negative Likelihood Ratio (NLR)
|
0 ratio
|
0.4 ratio
|
Adverse Events
Postpartum Glucose Sensor
Second Sensor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Grenye O'Malley
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place