Trial Outcomes & Findings for Does the Use of Continuous Glucose Monitoring (CGM) in the Immediate Postpartum Period in Women With Pregestational Diabetes Admitted to the Hospital Decrease Hypoglycemic Episodes (NCT NCT06141941)
NCT ID: NCT06141941
Last Updated: 2026-04-09
Results Overview
glucose values
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Postpartum admission, 2-5 days
Results posted on
2026-04-09
Participant Flow
pregnant women with Type 1 and Type 2 Diabetes Mellitus delivering at the University of Iowa Hospitals and Clinics
Participant milestones
| Measure |
T1DM
pregnant women with Type 1 DM
|
T2DM
pregnant women with type 2 DM
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
26
|
|
Overall Study
COMPLETED
|
13
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
T1DM
n=13 Participants
pregnant women with Type 1 DM
|
T2DM
n=26 Participants
pregnant women with type 2 DM
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=13 Participants
|
26 Participants
n=26 Participants
|
39 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=13 Participants
|
26 Participants
n=26 Participants
|
39 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Type of pregestational diabetes
|
13 Participants
n=13 Participants
|
26 Participants
n=26 Participants
|
39 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Postpartum admission, 2-5 daysglucose values
Outcome measures
| Measure |
Type I DM
n=13 Participants
Postpartum patients with Type 1 DM
|
Type II DM
n=26 Participants
Postpartum patients with Type II DM
|
|---|---|---|
|
Number of Participants With Hypoglycemia During Postpartum Hospital Stay
Without postpartum CGM (point of care glucometer)
|
4 participants
|
5 participants
|
|
Number of Participants With Hypoglycemia During Postpartum Hospital Stay
With postpartum CGM
|
5 participants
|
2 participants
|
Adverse Events
T1DM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T2DM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T1DM
n=13 participants at risk
pregnant women with Type 1 DM
|
T2DM
n=26 participants at risk
pregnant women with type 2 DM
|
|---|---|---|
|
Endocrine disorders
Point of care glucose < 40 mg/dL
|
0.00%
0/13 • Patients were monitored from enrollment until hospital discharge postpartum up to 5 days
Hypoglycemia \< 40 mg/dL on point of care glucometer
|
0.00%
0/26 • Patients were monitored from enrollment until hospital discharge postpartum up to 5 days
Hypoglycemia \< 40 mg/dL on point of care glucometer
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place