Trial Outcomes & Findings for CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes (NCT NCT04219085)
NCT ID: NCT04219085
Last Updated: 2025-08-28
Results Overview
The number of participants who have at least one of each of the following outcome measures occur: perinatal death, shoulder dystocia, birth weight less than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy. Any one of these would make the composite primary outcome positive and will be recorded as a categorical variable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
from enrollment up until delivery by 41 weeks gestation, up to 19 weeks total
Results posted on
2025-08-28
Participant Flow
Participant milestones
| Measure |
Routine Care
Monitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day
Routine Care: Use of a glucometer to monitor blood glucose levels in women with gestational diabetes
|
Continuous Glucose Monitor
Monitoring of control of gestational diabetes with use of a continuous glucose monitor
Continuous Glucose Monitor: Wearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
35
|
|
Overall Study
COMPLETED
|
30
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes
Baseline characteristics by cohort
| Measure |
Routine Care
n=30 Participants
Monitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day
Routine Care: Use of a glucometer to monitor blood glucose levels in women with gestational diabetes
|
Continuous Glucose Monitor
n=35 Participants
Monitoring of control of gestational diabetes with use of a continuous glucose monitor
Continuous Glucose Monitor: Wearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
35 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Gravidity
1 pregnancy
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Gravidity
2 pregnancies
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Gravidity
≥3 pregnancies
|
10 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Living Children
0 children
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Living Children
1child
|
9 participants
n=99 Participants
|
13 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Living Children
≥2 children
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Participant Body Mass Index (BMI) at Delivery
<25 kg/m^2
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Participant Body Mass Index (BMI) at Delivery
25-<30 kg/m^2
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Participant Body Mass Index (BMI) at Delivery
30-<35 kg/m^2
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Participant Body Mass Index (BMI) at Delivery
35-<40 kg/m^2
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Participant Body Mass Index (BMI) at Delivery
≥40 kg/m^2
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Insurance Type
Medicaid
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Insurance Type
Private
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Medication Type
Insulin
|
29 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Medication Type
Metformin
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
History of Gestational Diabetes Mellitus (GDM)
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Family History of GDM
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Gestational Age at GDM diagnosis
|
24.5 weeks
STANDARD_DEVIATION 1.1 • n=99 Participants
|
26 weeks
STANDARD_DEVIATION 28.2 • n=107 Participants
|
25.3 weeks
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
Gestational Age Starting Medications for GDM
|
27.4 weeks
STANDARD_DEVIATION 4.6 • n=99 Participants
|
28.2 weeks
STANDARD_DEVIATION 5.5 • n=107 Participants
|
27.8 weeks
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Gestational Age at Delivery
|
37.7 weeks
STANDARD_DEVIATION 1.4 • n=99 Participants
|
38 weeks
STANDARD_DEVIATION 1.3 • n=107 Participants
|
37.9 weeks
STANDARD_DEVIATION 1.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: from enrollment up until delivery by 41 weeks gestation, up to 19 weeks totalThe number of participants who have at least one of each of the following outcome measures occur: perinatal death, shoulder dystocia, birth weight less than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy. Any one of these would make the composite primary outcome positive and will be recorded as a categorical variable.
Outcome measures
| Measure |
Routine Care
n=30 Participants
Monitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day
Routine Care: Use of a glucometer to monitor blood glucose levels in women with gestational diabetes
|
Continuous Glucose Monitor
n=35 Participants
Monitoring of control of gestational diabetes with use of a continuous glucose monitor
Continuous Glucose Monitor: Wearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes
|
|---|---|---|
|
Composite Primary Outcome
Perinatal Death
|
0 Participants
|
0 Participants
|
|
Composite Primary Outcome
Shoulder Dystocia
|
0 Participants
|
0 Participants
|
|
Composite Primary Outcome
Birthweight < 4,000 grams
|
4 Participants
|
6 Participants
|
|
Composite Primary Outcome
NICU Admission for Hypoglycemia
|
4 Participants
|
4 Participants
|
|
Composite Primary Outcome
Birth Trauma
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: during delivery by 40 weeks gestationPopulation: Out of women who had c-sections
The number of women who undergo a cesarean delivery for arrest of dilation or descent during labor or induction of labor. This will be recorded as a categorical (yes/no) variable. Data presented below is for the participants that had c-section for arrest.
Outcome measures
| Measure |
Routine Care
n=22 Participants
Monitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day
Routine Care: Use of a glucometer to monitor blood glucose levels in women with gestational diabetes
|
Continuous Glucose Monitor
n=15 Participants
Monitoring of control of gestational diabetes with use of a continuous glucose monitor
Continuous Glucose Monitor: Wearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes
|
|---|---|---|
|
Cesarean Delivery for an Arrest of Labor Disorder
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: from enrollment, through delivery by 41 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum, up to 20 weeks totalThe number of women who receive a diagnosis of a hypertensive disorder of pregnancy (gestational hypertension, preeclampsia, HELLP). This will be recorded as a categorical (yes/no) variable
Outcome measures
| Measure |
Routine Care
n=30 Participants
Monitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day
Routine Care: Use of a glucometer to monitor blood glucose levels in women with gestational diabetes
|
Continuous Glucose Monitor
n=35 Participants
Monitoring of control of gestational diabetes with use of a continuous glucose monitor
Continuous Glucose Monitor: Wearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes
|
|---|---|---|
|
Hypertensive Disorders of Pregnancy.
|
5 Participants
|
7 Participants
|
Adverse Events
Routine Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Glucose Monitor
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place