Trial Outcomes & Findings for A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes (NCT NCT04803357)
NCT ID: NCT04803357
Last Updated: 2025-06-25
Results Overview
mean glucose CGM
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
36 weeks
Results posted on
2025-06-25
Participant Flow
Participant milestones
| Measure |
Control Group Blinded CGM
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level.
|
RT CGM Intervention Group
Real time continuous glucose monitor
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
|
Overall Study
COMPLETED
|
21
|
48
|
|
Overall Study
NOT COMPLETED
|
31
|
5
|
Reasons for withdrawal
| Measure |
Control Group Blinded CGM
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level.
|
RT CGM Intervention Group
Real time continuous glucose monitor
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
31
|
5
|
Baseline Characteristics
A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Baseline characteristics by cohort
| Measure |
Blinded CGM
n=21 Participants
Blinded Continuous monitoring device
|
RT- CGM
n=48 Participants
Real time Continuous monitoring device
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
34.2 years
STANDARD_DEVIATION 5.0 • n=107 Participants
|
33.7 years
STANDARD_DEVIATION 5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
69 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
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 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
|
7 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
21 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
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: Participants with \> 3 days of CGM data available at 36 weeks EGA
mean glucose CGM
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=18 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
Mean Glucose
|
103.0 mg/dl
Standard Deviation 10.9
|
106.2 mg/dl
Standard Deviation 9.6
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: Participants with \> 3 days of CGM data at 36 weeks EGA
Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=18 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
TIR CGM
|
92.1 % of time
Standard Deviation 8.5
|
92.4 % of time
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: deliveryPopulation: fetal live births with data available from hospital record or 1 self reported
Birth weight \[grams; mean (SD)\]
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=20 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
Fetal Birthweight
|
3309.5 grams
Standard Deviation 558
|
3198.2 grams
Standard Deviation 486.5
|
SECONDARY outcome
Timeframe: 36 weeksTime below range, 63 mg/dL threshold (TBR63) GDM
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=18 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
TBR CGM GDM
|
1.5 % of time
Standard Deviation 1.9
|
0.4 % of time
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 36 weeksTime above range, 140 mg/dL threshold (TAR140)
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=18 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
TAB CGM GDM
|
6.4 % of time
Standard Deviation 8.5
|
7.1 % of time
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 36 weeksMean Amplitude of glycemic excursions (MAGE) continuous glucoe monitoring
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=18 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
MAGE CGM
|
33.9 mg/dl
Standard Deviation 7.0
|
34.0 mg/dl
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 36 weeksstandard deviation Continuous glucose monitoring
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=18 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
SD CGM
|
18.6 mg/dl
Standard Deviation 4.0
|
18.8 mg/dl
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 36 weeksCoefficient of variation, % (CV)The Coefficient of Variation (%CV) is calculated by dividing the glucose Standard Deviation by the mean glucose. The %CV is a standardized measure that assesses the magnitude of glucose variability. The larger the %CV, the larger the variability in CGM readings.
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=18 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
CV CGM
|
18.1 percentage of variation
Standard Deviation 3.5
|
17.6 percentage of variation
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: deliveryPopulation: in livebirths with glucose available in the electronic medical record
number(%) \<40mg/dl of neonatal hypoglycemia
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=19 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=41 Participants
RT-CGM device wear
|
|---|---|---|
|
Neonatal Hypoglycemia
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: deliveryPopulation: gestational age of participants with data available
gestational age at delivery weeks mean (sd)
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=44 Participants
RT-CGM device wear
|
|---|---|---|
|
Gestational Age at Delivery
|
39.0 total time in weeks
Standard Deviation 1.6
|
38.5 total time in weeks
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: deliveryPopulation: participants with data available for mode of delivery
mode of deliver reported ( vaginal, c-section, operative vaginal)
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=44 Participants
RT-CGM device wear
|
|---|---|---|
|
Mode of Delivery
c-section
|
9 Participants
|
15 Participants
|
|
Mode of Delivery
vaginal
|
12 Participants
|
29 Participants
|
|
Mode of Delivery
operative vaginal
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: deliveryLabor Status on Admission -(induced, spontaneous, planned c-section
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=44 Participants
RT-CGM device wear
|
|---|---|---|
|
Type of Labor
spontaneous
|
11 Participants
|
21 Participants
|
|
Type of Labor
induced
|
2 Participants
|
9 Participants
|
|
Type of Labor
planned c-section
|
8 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: deliveryPopulation: data of participants with delivery data available
number with shoulder dystocia at delivery
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=44 Participants
RT-CGM device wear
|
|---|---|---|
|
Shoulder Dystocia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: deliveryPreeclampsia or Gestational hypertension (HTN )
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=44 Participants
RT-CGM device wear
|
|---|---|---|
|
Preeclampsia or HTN
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: deliveryPopulation: Participants with weight gain data at delivery, some missing data
Maternal weight gain \[lbs; mean (SD)\] at delivery
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=15 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=35 Participants
RT-CGM device wear
|
|---|---|---|
|
Maternal Weight Gain
|
21.1 pounds
Standard Deviation 7.8
|
18.9 pounds
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: at 36 weeksPopulation: all participants who completed
use of metformin and insulin in pregnancy
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=48 Participants
RT-CGM device wear
|
|---|---|---|
|
Diabetes Medication Use
|
2 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: deliveryPopulation: of patient's baby's with data available at delivery some missing data
5 minute apgar score A 5-minute Apgar score is a quick assessment of a newborn's overall health, particularly their ability to transition to life outside the womb. It's a score between 0 and 10, with each component (appearance, pulse, grimace, activity, and respirations) receiving a score of 0, 1, or 2. A score of 7-10 is considered reassuring, while scores below 7 may indicate the need for medical attentio
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=44 Participants
RT-CGM device wear
|
|---|---|---|
|
5 Minute Apgar
|
9 units on a scale
Standard Deviation 0.2
|
9 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: devliveryPopulation: with EMR data available about delivery or self reported
live birth or still birth at delivery
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=48 Participants
RT-CGM device wear
|
|---|---|---|
|
Live Birth or Stillbirth
live
|
21 Participants
|
48 Participants
|
|
Live Birth or Stillbirth
still
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: deliveryPopulation: of participant that had birthweights available at birth and gestational age at delivery,
Birthweight ratio Birth weight ratio is defined as the ratio of observed birth weight divided by the median birth weight of the population-specific reference growth curve (based on 50% weight for gestational age). It is used to compare the birth weight of a fetus to the median for its gestational age. Higher birth weight ratios indicate larger fetuses for their gestational age, while lower ratios indicate smaller fetuse.
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=20 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=43 Participants
RT-CGM device wear
|
|---|---|---|
|
Birthweight Ratio
|
1.015 ratio
Standard Deviation .1332
|
0.99 ratio
Standard Deviation 0.1097
|
SECONDARY outcome
Timeframe: deliveryPopulation: of data available at delivery some data missing as delivered at outside hospital without record accesss or by self-report by participant
Need for neonatal intensive care admission
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=19 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
NICU Admission
|
1 participants' infant
|
3 participants' infant
|
SECONDARY outcome
Timeframe: deliveryPopulation: fetal data available on EMR review some data not available as delivered outside source
neonatal respiratory distress, birth injury, hypoxic encephalopathy
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=19 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
Neonatal Complications
respiratory distress
|
1 Participants
|
1 Participants
|
|
Neonatal Complications
birth injury
|
0 Participants
|
0 Participants
|
|
Neonatal Complications
hypoxic encephalopathy
|
0 Participants
|
0 Participants
|
|
Neonatal Complications
none
|
18 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: participants with fingerstick data available at 36 weeks EGA ; some missing data as participants did not provide glucose meter data
mean number of fingersticks per day by 36 weeks
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=14 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=17 Participants
RT-CGM device wear
|
|---|---|---|
|
Glucose Meter Fingerstick Per Day
|
3.4 fingersticks per day
Standard Deviation 0.8
|
0.9 fingersticks per day
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 36 weeksMean (SD) days of RT-CGM use
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=47 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
RT-CGM device wear
|
|---|---|---|
|
Mean Days of RT-CGM Use
|
64.4 days worn
Standard Deviation 19.4
|
—
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: participants with A1c at 36 weeks some missing data
A1c at 36 weeks
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=18 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=37 Participants
RT-CGM device wear
|
|---|---|---|
|
A1c
|
5.4 % of A1c
Standard Deviation 0.4
|
5.4 % of A1c
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: participants with fructoasmine data at 36 weeks Some missing data
frucosamine at 36 weeks
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=16 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=37 Participants
RT-CGM device wear
|
|---|---|---|
|
Fructosamine
|
191.9 umol/L
Standard Deviation 11.4
|
194.7 umol/L
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: of those that answered the short food question survey
starting the conversation food questionnaire Possible scores range from 0 to 16 with lower scores indicating better nutrition including more fruits and vegtables, and less or no sugared beverages.. The most healthful answer for each question is scored 0. The less healthful answer is scored 1. The least healthful answer is scored 2. To get a total score, add up the individual item scores. The total score ranges from 0 to 16. Lower scores indicate better nutrition
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=48 Participants
RT-CGM device wear
|
|---|---|---|
|
Short Food Questionnaire
|
3.8 score on a scale
Standard Deviation 1.8
|
5.7 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: of those that answered the QOL survey
World health organization Quality of Life survey Possible scores range from 0 to 25 with higher scores indicating more happiness or contentment.
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=18 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
WHO QOL Scale
|
16.2 units on a scale
Standard Deviation 3.6
|
15.3 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: of those that answered the paid survey
5 items diabetes distress score Possible total score ranges from 0 to 20. Higher scores indicate more emotional distress.
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=48 Participants
RT-CGM device wear
|
|---|---|---|
|
Diabetes Distress(PAID) Survey
|
7.0 score on a scale
Standard Deviation 4.9
|
8.9 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: over those that answered the physical activity survey
% of participants walking greater than 10 minutes or more per day
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=45 Participants
RT-CGM device wear
|
|---|---|---|
|
Walking Time Physcial Active Questionnaire
|
95 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: at 36 weeksPopulation: all participants who completed
use of metformin only
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=48 Participants
RT-CGM device wear
|
|---|---|---|
|
Metformin Only Use
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: at 36 weeksPopulation: all participants who completed
use of insulin only
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=48 Participants
RT-CGM device wear
|
|---|---|---|
|
Insulin Use Only
|
1 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: at deliveryPopulation: all participants who completed
use of insulin only
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=48 Participants
RT-CGM device wear
|
|---|---|---|
|
Insulin Use Only
|
1 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: at deliveryPopulation: all participants who completed
use of metformin and insulin in pregnancy
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=48 Participants
RT-CGM device wear
|
|---|---|---|
|
Diabetes Medication Use Delivery
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: at deliveryPopulation: all participants who completed
use of metformin only at time of delivery
Outcome measures
| Measure |
Blinded Continuous Glucose Monitoring Devise
n=21 Participants
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
|
RT-CGM
n=48 Participants
RT-CGM device wear
|
|---|---|---|
|
Metformin Use Only at Delivery
|
3 Participants
|
7 Participants
|
Adverse Events
Blinded CGM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RT- CGM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blinded CGM
n=21 participants at risk
Blinded Continuous monitoring device
|
RT- CGM
n=48 participants at risk
Real time Continuous monitoring device
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
bleeding or irritation at device site
|
0.00%
0/21 • 3 to 6.5 months(duration of pregnancy)
|
6.2%
3/48 • Number of events 3 • 3 to 6.5 months(duration of pregnancy)
|
Additional Information
Dr, Nicole Ehrhardt
university of Washington Diabetes Institute
Phone: 2404479566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place