Trial Outcomes & Findings for Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy (NCT NCT02556554)
NCT ID: NCT02556554
Last Updated: 2020-07-21
Results Overview
Glucose variability as measured by glucose excursions from CGM
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
From first pregnancy visit to delivery
Results posted on
2020-07-21
Participant Flow
From 08/2015 to 06/2016, investigators enrolled women in preconception and the 1st trimester at the Barbara Davis Center, and followers. Other women consented for the retrospective (no CGM) group. Follower data only included answers to monthly questionnaires. Study registration was delayed due to staffing issues and account set-up in the system.
Study cohorts: (1) women with T1D prospectively enrolled in 1st trimester or when planning pregnancy, (2) followers (family/friends) of women in the 1st cohort, and (3) women with T1D with a pregnancy within the past 3 years who did not use CGM therapy during gestation (retrospective). Follower data only included answers to monthly questionnaires.
Participant milestones
| Measure |
Routine Care
Standard of Care in the Pregnancy and Women's Health clinic.
|
Dexcom G4 Platinum CGM System
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
|
Dexcom G4 Platinum CGM System With Share™
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
Followers for Dexcom Alone
Followers of Pregnant Women Using Dexcom Alone
|
Followers for Dexcom Share
Followers of Pregnant Women Using Dexcom with Share
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
14
|
19
|
12
|
14
|
|
Overall Study
COMPLETED
|
8
|
13
|
15
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
4
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
Baseline characteristics by cohort
| Measure |
Routine Care
n=8 Participants
Standard of Care in the Pregnancy and Women's Health clinic.
|
Dexcom G4 Platinum CGM System
n=13 Participants
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
|
Dexcom G4 Platinum CGM System With Share™
n=15 Participants
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
13 Participants
n=13 Participants
|
15 Participants
n=15 Participants
|
36 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
27.6 years
n=8 Participants
|
24.4 years
n=13 Participants
|
28.9 years
n=15 Participants
|
27.3 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=8 Participants
|
13 Participants
n=13 Participants
|
15 Participants
n=15 Participants
|
36 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Caucasian
|
—
|
8 Participants
n=13 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
14 Participants
n=15 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
22 Participants
n=28 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic/Latina
|
—
|
3 Participants
n=13 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
1 Participants
n=15 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
4 Participants
n=28 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian/Oriental
|
—
|
1 Participants
n=13 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
0 Participants
n=15 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
1 Participants
n=28 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
—
|
1 Participants
n=13 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
0 Participants
n=15 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
1 Participants
n=28 Participants • Race/ethnicity data were not obtained from retrospective chart review (no CGM) group.
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
13 participants
n=13 Participants
|
15 participants
n=15 Participants
|
36 participants
n=36 Participants
|
|
Method of insulin delivery, n (%)
Multiple daily injections (MDI)
|
4 Participants
n=8 Participants
|
7 Participants
n=13 Participants
|
2 Participants
n=15 Participants
|
13 Participants
n=36 Participants
|
|
Method of insulin delivery, n (%)
Continuous subcutaneous insulin infusion (CSII)
|
3 Participants
n=8 Participants
|
6 Participants
n=13 Participants
|
13 Participants
n=15 Participants
|
22 Participants
n=36 Participants
|
|
Method of insulin delivery, n (%)
Unknown
|
1 Participants
n=8 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=36 Participants
|
|
Preconception hemoglobin A1C (%)
|
7.2 %
n=8 Participants
|
8.1 %
n=13 Participants
|
7.1 %
n=15 Participants
|
7.4 %
n=36 Participants
|
PRIMARY outcome
Timeframe: From first pregnancy visit to deliveryPopulation: CGM metrics among CGM Share and CGM Alone (not among no CGM since they did not use a CGM)
Glucose variability as measured by glucose excursions from CGM
Outcome measures
| Measure |
Dexcom G4 Platinum CGM System
n=13 Participants
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
|
Dexcom G4 Platinum CGM System With Share™
n=15 Participants
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
Dexcom G4 Platinum CGM System With Share™
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
|---|---|---|---|
|
Changes in Glucose Variability
Time spent <65 mg/dL (3rd trimester)
|
4.0 % time spent in range
Interval 3.6 to 4.6
|
4.5 % time spent in range
Interval 3.4 to 6.1
|
—
|
|
Changes in Glucose Variability
Time spent 65-140 mg/dL (3rd trimester)
|
53.5 % time spent in range
Interval 42.6 to 59.4
|
62.3 % time spent in range
Interval 49.9 to 70.4
|
—
|
|
Changes in Glucose Variability
Time spent <65 mg/dL (1st trimester)
|
7.5 % time spent in range
Interval 4.7 to 9.0
|
7.3 % time spent in range
Interval 3.6 to 8.2
|
—
|
|
Changes in Glucose Variability
Time spent 65-140 mg/dL (1st trimester)
|
52.8 % time spent in range
Interval 46.4 to 73.0
|
59.8 % time spent in range
Interval 54.5 to 68.7
|
—
|
|
Changes in Glucose Variability
Time spent >140 mg/dL (1st trimester)
|
38.2 % time spent in range
Interval 21.7 to 49.0
|
35.1 % time spent in range
Interval 24.3 to 41.0
|
—
|
|
Changes in Glucose Variability
Time spent <65 mg/dL (2nd trimester)
|
5.0 % time spent in range
Interval 3.8 to 7.5
|
5.3 % time spent in range
Interval 4.0 to 8.4
|
—
|
|
Changes in Glucose Variability
Time spent 65-140 mg/dL (2nd trimester)
|
50.7 % time spent in range
Interval 43.6 to 61.8
|
56.6 % time spent in range
Interval 48.7 to 69.0
|
—
|
|
Changes in Glucose Variability
Time spent >140 mg/dL (2nd trimester)
|
44.2 % time spent in range
Interval 27.8 to 51.7
|
37.2 % time spent in range
Interval 21.9 to 43.1
|
—
|
|
Changes in Glucose Variability
Time spent >140 mg/dL (3rd trimester)
|
43.2 % time spent in range
Interval 35.4 to 52.8
|
34.4 % time spent in range
Interval 23.1 to 46.8
|
—
|
PRIMARY outcome
Timeframe: From first pregnancy visit to deliveryPopulation: Hypoglycemia Fear Survey results (higher scores indicate more behavioral changes, worry, or total fear scores). Only prospectively enrolled pregnant women were administered this questionnaire (CGM Alone and CGM Share groups).
Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome.
Outcome measures
| Measure |
Dexcom G4 Platinum CGM System
n=13 Participants
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
|
Dexcom G4 Platinum CGM System With Share™
n=15 Participants
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
Dexcom G4 Platinum CGM System With Share™
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
|---|---|---|---|
|
Change(s) in Behavior and/or Concerns of Diabetics.
Behavior score (1st trimester)
|
28.8 score on a scale
Standard Deviation 5.8
|
27.9 score on a scale
Standard Deviation 3.9
|
—
|
|
Change(s) in Behavior and/or Concerns of Diabetics.
Worry Score (1st Trimester)
|
45.1 score on a scale
Standard Deviation 14.8
|
34.0 score on a scale
Standard Deviation 7.2
|
—
|
|
Change(s) in Behavior and/or Concerns of Diabetics.
Total Score (1st Trimester)
|
73.8 score on a scale
Standard Deviation 14.1
|
61.9 score on a scale
Standard Deviation 9.4
|
—
|
|
Change(s) in Behavior and/or Concerns of Diabetics.
Behavior score (2nd trimester)
|
28.2 score on a scale
Standard Deviation 6.9
|
28.9 score on a scale
Standard Deviation 4.5
|
—
|
|
Change(s) in Behavior and/or Concerns of Diabetics.
Worry Score (2nd Trimester)
|
37.5 score on a scale
Standard Deviation 12.5
|
34.6 score on a scale
Standard Deviation 9.7
|
—
|
|
Change(s) in Behavior and/or Concerns of Diabetics.
Total Score (2nd Trimester)
|
65.8 score on a scale
Standard Deviation 15.4
|
63.4 score on a scale
Standard Deviation 13.0
|
—
|
|
Change(s) in Behavior and/or Concerns of Diabetics.
Behavior score (3rd trimester)
|
28.6 score on a scale
Standard Deviation 6.6
|
28.2 score on a scale
Standard Deviation 4.1
|
—
|
|
Change(s) in Behavior and/or Concerns of Diabetics.
Worry Score (3rd Trimester)
|
43.4 score on a scale
Standard Deviation 19
|
37.4 score on a scale
Standard Deviation 7.8
|
—
|
|
Change(s) in Behavior and/or Concerns of Diabetics.
Total Score (3rd Trimester)
|
72.0 score on a scale
Standard Deviation 23.8
|
65.5 score on a scale
Standard Deviation 10.7
|
—
|
SECONDARY outcome
Timeframe: From first pregnancy visit to deliveryPopulation: Least squares mean HbA1c by group in a model without interaction and without adjustment for preconception HbA1c.
Change in A1C with CGM alone and CGM with Share™ compared to no CGM use.
Outcome measures
| Measure |
Dexcom G4 Platinum CGM System
n=8 Participants
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
|
Dexcom G4 Platinum CGM System With Share™
n=13 Participants
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
Dexcom G4 Platinum CGM System With Share™
n=15 Participants
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
|---|---|---|---|
|
Change in A1C.
|
6.85 HbA1C %
Standard Error 0.13
|
6.84 HbA1C %
Standard Error 0.09
|
6.19 HbA1C %
Standard Error 0.07
|
SECONDARY outcome
Timeframe: From first pregnancy visit to deliveryPopulation: Maternal and fetal outcomes among prospective pregnant study arms (CGM Share and CGM Alone)
Evaluation of Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal hypoglycemia, and other similar measures)
Outcome measures
| Measure |
Dexcom G4 Platinum CGM System
n=13 Participants
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
|
Dexcom G4 Platinum CGM System With Share™
n=15 Participants
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
Dexcom G4 Platinum CGM System With Share™
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
|---|---|---|---|
|
Evaluation of Maternal and Fetal Outcomes.
Cesarean section, n (%)
|
8 Participants
|
13 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Preeclampsia, n (%)
|
4 Participants
|
4 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
<37 weeks gestation at delivery, n (%)
|
7 Participants
|
4 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Large-for-gestational age infant, n (%)
|
5 Participants
|
8 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Macrosomia, n (%)
|
0 Participants
|
3 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Small-for-gestational age infant, n (%)
|
0 Participants
|
1 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Neonatal hypoglycemia, n (%)
|
7 Participants
|
11 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Neonatal jaundice, n (%)
|
8 Participants
|
5 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Neonatal hypoxemia, n (%)
|
6 Participants
|
1 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Neonatal intensive care unit admission, n (%)
|
5 Participants
|
7 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Progression of diabetic retinopathy (both eyes)
|
2 Participants
|
2 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Progression of diabetic retionpathy (one eye)
|
3 Participants
|
2 Participants
|
—
|
|
Evaluation of Maternal and Fetal Outcomes.
Progression of diabetic retinopathy (neither eye)
|
5 Participants
|
4 Participants
|
—
|
Adverse Events
Dexcom G4 Platinum CGM System
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexcom G4 Platinum CGM System With Share™
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Followers of Dexcom G4 Platinum CGM System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Followers of Dexcom G4 Platinum CGM System With Share™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexcom G4 Platinum CGM System
n=13 participants at risk
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
|
Dexcom G4 Platinum CGM System With Share™
n=15 participants at risk
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
|
Followers of Dexcom G4 Platinum CGM System
n=12 participants at risk
Followers (family or friends) of Dexcom G4 Platinum CGM system
|
Followers of Dexcom G4 Platinum CGM System With Share™
n=14 participants at risk
Followers (family or friends) of Dexcom G4 Platinum CGM system with Share™
|
|---|---|---|---|---|
|
Endocrine disorders
severe hypoglycemic episode
|
0.00%
0/13 • Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone)
Severe hypoglycemia was defined as glucose \<70 mg/dL requiring the assistance of a third party. Miscarriage was defined as 1st trimester fetal loss (women who miscarried and became pregnant again during the enrollment period could re-enroll). Number at risk for miscarriage includes all pregnancies, but number at risk for mortality includes participants (not individual pregnancies). Adverse events were captured and recorded only in prospectively enrolled arms (does not include no CGM group).
|
13.3%
2/15 • Number of events 3 • Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone)
Severe hypoglycemia was defined as glucose \<70 mg/dL requiring the assistance of a third party. Miscarriage was defined as 1st trimester fetal loss (women who miscarried and became pregnant again during the enrollment period could re-enroll). Number at risk for miscarriage includes all pregnancies, but number at risk for mortality includes participants (not individual pregnancies). Adverse events were captured and recorded only in prospectively enrolled arms (does not include no CGM group).
|
0.00%
0/12 • Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone)
Severe hypoglycemia was defined as glucose \<70 mg/dL requiring the assistance of a third party. Miscarriage was defined as 1st trimester fetal loss (women who miscarried and became pregnant again during the enrollment period could re-enroll). Number at risk for miscarriage includes all pregnancies, but number at risk for mortality includes participants (not individual pregnancies). Adverse events were captured and recorded only in prospectively enrolled arms (does not include no CGM group).
|
0.00%
0/14 • Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone)
Severe hypoglycemia was defined as glucose \<70 mg/dL requiring the assistance of a third party. Miscarriage was defined as 1st trimester fetal loss (women who miscarried and became pregnant again during the enrollment period could re-enroll). Number at risk for miscarriage includes all pregnancies, but number at risk for mortality includes participants (not individual pregnancies). Adverse events were captured and recorded only in prospectively enrolled arms (does not include no CGM group).
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
23.1%
3/13 • Number of events 3 • Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone)
Severe hypoglycemia was defined as glucose \<70 mg/dL requiring the assistance of a third party. Miscarriage was defined as 1st trimester fetal loss (women who miscarried and became pregnant again during the enrollment period could re-enroll). Number at risk for miscarriage includes all pregnancies, but number at risk for mortality includes participants (not individual pregnancies). Adverse events were captured and recorded only in prospectively enrolled arms (does not include no CGM group).
|
13.3%
2/15 • Number of events 2 • Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone)
Severe hypoglycemia was defined as glucose \<70 mg/dL requiring the assistance of a third party. Miscarriage was defined as 1st trimester fetal loss (women who miscarried and became pregnant again during the enrollment period could re-enroll). Number at risk for miscarriage includes all pregnancies, but number at risk for mortality includes participants (not individual pregnancies). Adverse events were captured and recorded only in prospectively enrolled arms (does not include no CGM group).
|
0.00%
0/12 • Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone)
Severe hypoglycemia was defined as glucose \<70 mg/dL requiring the assistance of a third party. Miscarriage was defined as 1st trimester fetal loss (women who miscarried and became pregnant again during the enrollment period could re-enroll). Number at risk for miscarriage includes all pregnancies, but number at risk for mortality includes participants (not individual pregnancies). Adverse events were captured and recorded only in prospectively enrolled arms (does not include no CGM group).
|
0.00%
0/14 • Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone)
Severe hypoglycemia was defined as glucose \<70 mg/dL requiring the assistance of a third party. Miscarriage was defined as 1st trimester fetal loss (women who miscarried and became pregnant again during the enrollment period could re-enroll). Number at risk for miscarriage includes all pregnancies, but number at risk for mortality includes participants (not individual pregnancies). Adverse events were captured and recorded only in prospectively enrolled arms (does not include no CGM group).
|
Other adverse events
Adverse event data not reported
Additional Information
Sarit Polsky, MD, MPH
Regents of the University of Colorado
Phone: 3037248575
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place