Gestational Diabetes
Conditions
Brief summary
The purpose of this study is to examine whether RT-CGM (real time continuous glucose monitoring) use improves glucose control, maternal outcomes, and fetal outcomes in patients diagnosed with gestational diabetes. Currently, there is very limited data on whether RT-CGM use helps patients diagnosed with gestational diabetes. By conducting this study, the investigator hopes to develop a deeper understanding of how use of a RT-CGM may affect glucose control in the gestational diabetes population.
Detailed description
Pregnant Participants diagnosed with gestational diabetes are being invited to take part in a research study because these participants are pregnant and have gestational diabetes. Participants will be offered an opportunity to wear a medical device that monitors blood sugars (glucose). This device is called a continuous glucose monitor (CGM). The CGM measures glucose levels through a tiny plastic filament that is inserted under the skin in the abdomen by a skin prick. Typically, participants cannot feel this device once it is inserted. If participants agree to participate in this study, participants will be randomly placed into one of two groups: (1) the intervention group or (2) the control group. Participants will have a 50% (1 out of 2) chance like a coin toss of being placed into either group. If participants are in the intervention group, they will wear a real-time continuous glucose monitoring device (RT-CGM). The RT-CGM will allow participants to see glucose levels in real time. The RT-CGM will send information about glucose levels to a phone or display device so participants may see the glucose at all times. If participants are in the control group, they will not be given a RT-CGM. Instead, participants will be given a blinded CGM device. You will not be able to view your blood sugar results on the blinded CGM device. If participants are in the control group, they will also be given a blood glucose meter to check glucose using finger sticks according to the recommendations of the provider.
Interventions
DEVICEContinuous glucose monitor
We are offering you an opportunity to wear a medical device that monitors your blood sugars (glucose). This device is called a continuous glucose monitor (CGM). The CGM measures glucose levels through a tiny plastic filament that is inserted under the skin in your abdomen by a skin prick. Typically, you cannot feel this device once it is inserted.
Sponsors
DexCom, Inc.
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
If you are in the control group, you will not be given a RT-CGM. Instead, you will be given a blinded CGM device. You will not be able to view your blood sugar results on the blinded CGM device. If you are in the control group, you will also be given a blood glucose meter to check your glucose using finger sticks according to the recommendations of your provider.
Intervention model description
Real- time continuous glucose monitoring using the DexCom G6.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
1. Pregnancy and Gestation \< 30 weeks 2. Singleton pregnancy 3. Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c) 4. Able to read English and completed 6th grade 5. Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 \[HIPAA\] legislation), communicate with the investigator, and understand and comply with protocol requirements
Exclusion criteria
1. Pre-gestational Type 1 or Type 2 diabetes. 2. Newly diagnosed overt-diabetes in pregnancy \[HbA1c ≥ 48 mmol/mol (6.5%), fasting glucose ≥ 7.0 mmol/l, random glucose ≥ 11.1 mmol/l\]. 3. Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM 4. Known endogenous/exogenous Cushing's syndrome 5. Known chronic infections 6. Current use of any oral form of steroid medication 7. Already receiving continuous glucose monitoring (CGM) 8. History of bariatric surgery 9. Gestational Age less than 14 weeks -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Glucose | 36 weeks | mean glucose CGM |
| TIR CGM | 36 weeks | Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TAB CGM GDM | 36 weeks | Time above range, 140 mg/dL threshold (TAR140) |
| MAGE CGM | 36 weeks | Mean Amplitude of glycemic excursions (MAGE) continuous glucoe monitoring |
| SD CGM | 36 weeks | standard deviation Continuous glucose monitoring |
| CV CGM | 36 weeks | Coefficient 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. |
| Neonatal Hypoglycemia | delivery | number(%) \<40mg/dl of neonatal hypoglycemia |
| Gestational Age at Delivery | delivery | gestational age at delivery weeks mean (sd) |
| Mode of Delivery | delivery | mode of deliver reported ( vaginal, c-section, operative vaginal) |
| Type of Labor | delivery | Labor Status on Admission -(induced, spontaneous, planned c-section |
| Shoulder Dystocia | delivery | number with shoulder dystocia at delivery |
| Preeclampsia or HTN | delivery | Preeclampsia or Gestational hypertension (HTN ) |
| Maternal Weight Gain | delivery | Maternal weight gain \[lbs; mean (SD)\] at delivery |
| Diabetes Medication Use | at 36 weeks | use of metformin and insulin in pregnancy |
| 5 Minute Apgar | delivery | 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 |
| Live Birth or Stillbirth | devlivery | live birth or still birth at delivery |
| Fetal Birthweight | delivery | Birth weight \[grams; mean (SD)\] |
| NICU Admission | delivery | Need for neonatal intensive care admission |
| Neonatal Complications | delivery | neonatal respiratory distress, birth injury, hypoxic encephalopathy |
| Glucose Meter Fingerstick Per Day | 36 weeks | mean number of fingersticks per day by 36 weeks |
| Mean Days of RT-CGM Use | 36 weeks | Mean (SD) days of RT-CGM use |
| A1c | 36 weeks | A1c at 36 weeks |
| Fructosamine | 36 weeks | frucosamine at 36 weeks |
| Short Food Questionnaire | 36 weeks | 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 |
| WHO QOL Scale | 36 weeks | World health organization Quality of Life survey Possible scores range from 0 to 25 with higher scores indicating more happiness or contentment. |
| Diabetes Distress(PAID) Survey | 36 weeks | 5 items diabetes distress score Possible total score ranges from 0 to 20. Higher scores indicate more emotional distress. |
| Walking Time Physcial Active Questionnaire | 36 weeks | % of participants walking greater than 10 minutes or more per day |
| Metformin Only Use | at 36 weeks | use of metformin only |
| Insulin Use Only | at 36 weeks | use of insulin only |
| Diabetes Medication Use Delivery | at delivery | use of metformin and insulin in pregnancy |
| Metformin Use Only at Delivery | at delivery | use of metformin only at time of delivery |
| Birthweight Ratio | 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. |
| TBR CGM GDM | 36 weeks | Time below range, 63 mg/dL threshold (TBR63) GDM |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blinded CGM Blinded Continuous monitoring device | 21 |
| RT- CGM Real time Continuous monitoring device | 48 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 31 | 5 |
Baseline characteristics
| Characteristic | RT- CGM | Total | Blinded CGM |
|---|---|---|---|
| Age, Continuous | 34.2 years STANDARD_DEVIATION 5 | 33.7 years STANDARD_DEVIATION 5 | 33.2 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 9 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 57 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 21 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) White | 23 Participants | 30 Participants | 7 Participants |
| Sex: Female, Male Female | 48 Participants | 69 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 48 |
| other Total, other adverse events | 0 / 21 | 3 / 48 |
| serious Total, serious adverse events | 0 / 21 | 0 / 48 |
Outcome results
Primary
Mean Glucose
mean glucose CGM
Time frame: 36 weeks
Population: Participants with \> 3 days of CGM data available at 36 weeks EGA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Mean Glucose | 103.0 mg/dl | Standard Deviation 10.9 |
| RT-CGM | Mean Glucose | 106.2 mg/dl | Standard Deviation 9.6 |
Primary
TIR CGM
Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring
Time frame: 36 weeks
Population: Participants with \> 3 days of CGM data at 36 weeks EGA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | TIR CGM | 92.1 % of time | Standard Deviation 8.5 |
| RT-CGM | TIR CGM | 92.4 % of time | Standard Deviation 7.8 |
Secondary
5 Minute Apgar
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
Time frame: delivery
Population: of patient's baby's with data available at delivery some missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | 5 Minute Apgar | 9 units on a scale | Standard Deviation 0.2 |
| RT-CGM | 5 Minute Apgar | 9 units on a scale | Standard Deviation 0.2 |
Secondary
A1c
A1c at 36 weeks
Time frame: 36 weeks
Population: participants with A1c at 36 weeks some missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | A1c | 5.4 % of A1c | Standard Deviation 0.4 |
| RT-CGM | A1c | 5.4 % of A1c | Standard Deviation 0.4 |
Secondary
Birthweight Ratio
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.
Time frame: delivery
Population: of participant that had birthweights available at birth and gestational age at delivery,
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Birthweight Ratio | 1.015 ratio | Standard Deviation 0.1332 |
| RT-CGM | Birthweight Ratio | 0.99 ratio | Standard Deviation 0.1097 |
Secondary
CV CGM
Coefficient 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.
Time frame: 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | CV CGM | 18.1 percentage of variation | Standard Deviation 3.5 |
| RT-CGM | CV CGM | 17.6 percentage of variation | Standard Deviation 3.1 |
Secondary
Diabetes Distress(PAID) Survey
5 items diabetes distress score Possible total score ranges from 0 to 20. Higher scores indicate more emotional distress.
Time frame: 36 weeks
Population: of those that answered the paid survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Diabetes Distress(PAID) Survey | 7.0 score on a scale | Standard Deviation 4.9 |
| RT-CGM | Diabetes Distress(PAID) Survey | 8.9 score on a scale | Standard Deviation 4.9 |
Secondary
Diabetes Medication Use
use of metformin and insulin in pregnancy
Time frame: at 36 weeks
Population: all participants who completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Diabetes Medication Use | 2 Participants |
| RT-CGM | Diabetes Medication Use | 10 Participants |
Secondary
Diabetes Medication Use Delivery
use of metformin and insulin in pregnancy
Time frame: at delivery
Population: all participants who completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Diabetes Medication Use Delivery | 2 Participants |
| RT-CGM | Diabetes Medication Use Delivery | 11 Participants |
Secondary
Fetal Birthweight
Birth weight \[grams; mean (SD)\]
Time frame: delivery
Population: fetal live births with data available from hospital record or 1 self reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Fetal Birthweight | 3309.5 grams | Standard Deviation 558 |
| RT-CGM | Fetal Birthweight | 3198.2 grams | Standard Deviation 486.5 |
Secondary
Fructosamine
frucosamine at 36 weeks
Time frame: 36 weeks
Population: participants with fructoasmine data at 36 weeks Some missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Fructosamine | 191.9 umol/L | Standard Deviation 11.4 |
| RT-CGM | Fructosamine | 194.7 umol/L | Standard Deviation 20.1 |
Secondary
Gestational Age at Delivery
gestational age at delivery weeks mean (sd)
Time frame: delivery
Population: gestational age of participants with data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Gestational Age at Delivery | 39.0 total time in weeks | Standard Deviation 1.6 |
| RT-CGM | Gestational Age at Delivery | 38.5 total time in weeks | Standard Deviation 1.5 |
Secondary
Glucose Meter Fingerstick Per Day
mean number of fingersticks per day by 36 weeks
Time frame: 36 weeks
Population: participants with fingerstick data available at 36 weeks EGA ; some missing data as participants did not provide glucose meter data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Glucose Meter Fingerstick Per Day | 3.4 fingersticks per day | Standard Deviation 0.8 |
| RT-CGM | Glucose Meter Fingerstick Per Day | 0.9 fingersticks per day | Standard Deviation 1 |
Secondary
Insulin Use Only
use of insulin only
Time frame: at delivery
Population: all participants who completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Insulin Use Only | 1 Participants |
| RT-CGM | Insulin Use Only | 14 Participants |
Secondary
Insulin Use Only
use of insulin only
Time frame: at 36 weeks
Population: all participants who completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Insulin Use Only | 1 Participants |
| RT-CGM | Insulin Use Only | 14 Participants |
Secondary
Live Birth or Stillbirth
live birth or still birth at delivery
Time frame: devlivery
Population: with EMR data available about delivery or self reported
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Live Birth or Stillbirth | live | 21 Participants |
| Blinded Continuous Glucose Monitoring Devise | Live Birth or Stillbirth | still | 0 Participants |
| RT-CGM | Live Birth or Stillbirth | live | 48 Participants |
| RT-CGM | Live Birth or Stillbirth | still | 0 Participants |
Secondary
MAGE CGM
Mean Amplitude of glycemic excursions (MAGE) continuous glucoe monitoring
Time frame: 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | MAGE CGM | 33.9 mg/dl | Standard Deviation 7 |
| RT-CGM | MAGE CGM | 34.0 mg/dl | Standard Deviation 7.7 |
Secondary
Maternal Weight Gain
Maternal weight gain \[lbs; mean (SD)\] at delivery
Time frame: delivery
Population: Participants with weight gain data at delivery, some missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Maternal Weight Gain | 21.1 pounds | Standard Deviation 7.8 |
| RT-CGM | Maternal Weight Gain | 18.9 pounds | Standard Deviation 9.5 |
Secondary
Mean Days of RT-CGM Use
Mean (SD) days of RT-CGM use
Time frame: 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Mean Days of RT-CGM Use | 64.4 days worn | Standard Deviation 19.4 |
Secondary
Metformin Only Use
use of metformin only
Time frame: at 36 weeks
Population: all participants who completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Metformin Only Use | 4 Participants |
| RT-CGM | Metformin Only Use | 8 Participants |
Secondary
Metformin Use Only at Delivery
use of metformin only at time of delivery
Time frame: at delivery
Population: all participants who completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Metformin Use Only at Delivery | 3 Participants |
| RT-CGM | Metformin Use Only at Delivery | 7 Participants |
Secondary
Mode of Delivery
mode of deliver reported ( vaginal, c-section, operative vaginal)
Time frame: delivery
Population: participants with data available for mode of delivery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Mode of Delivery | c-section | 9 Participants |
| Blinded Continuous Glucose Monitoring Devise | Mode of Delivery | vaginal | 12 Participants |
| Blinded Continuous Glucose Monitoring Devise | Mode of Delivery | operative vaginal | 0 Participants |
| RT-CGM | Mode of Delivery | c-section | 15 Participants |
| RT-CGM | Mode of Delivery | vaginal | 29 Participants |
| RT-CGM | Mode of Delivery | operative vaginal | 0 Participants |
Secondary
Neonatal Complications
neonatal respiratory distress, birth injury, hypoxic encephalopathy
Time frame: delivery
Population: fetal data available on EMR review some data not available as delivered outside source
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Neonatal Complications | respiratory distress | 1 Participants |
| Blinded Continuous Glucose Monitoring Devise | Neonatal Complications | birth injury | 0 Participants |
| Blinded Continuous Glucose Monitoring Devise | Neonatal Complications | hypoxic encephalopathy | 0 Participants |
| Blinded Continuous Glucose Monitoring Devise | Neonatal Complications | none | 18 Participants |
| RT-CGM | Neonatal Complications | none | 44 Participants |
| RT-CGM | Neonatal Complications | respiratory distress | 1 Participants |
| RT-CGM | Neonatal Complications | hypoxic encephalopathy | 0 Participants |
| RT-CGM | Neonatal Complications | birth injury | 0 Participants |
Secondary
Neonatal Hypoglycemia
number(%) \<40mg/dl of neonatal hypoglycemia
Time frame: delivery
Population: in livebirths with glucose available in the electronic medical record
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Neonatal Hypoglycemia | 0 Participants |
| RT-CGM | Neonatal Hypoglycemia | 4 Participants |
Secondary
NICU Admission
Need for neonatal intensive care admission
Time frame: delivery
Population: of data available at delivery some data missing as delivered at outside hospital without record accesss or by self-report by participant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | NICU Admission | 1 participants' infant |
| RT-CGM | NICU Admission | 3 participants' infant |
Secondary
Preeclampsia or HTN
Preeclampsia or Gestational hypertension (HTN )
Time frame: delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Preeclampsia or HTN | 2 Participants |
| RT-CGM | Preeclampsia or HTN | 7 Participants |
Secondary
SD CGM
standard deviation Continuous glucose monitoring
Time frame: 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | SD CGM | 18.6 mg/dl | Standard Deviation 4 |
| RT-CGM | SD CGM | 18.8 mg/dl | Standard Deviation 4.3 |
Secondary
Short Food Questionnaire
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
Time frame: 36 weeks
Population: of those that answered the short food question survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Short Food Questionnaire | 3.8 score on a scale | Standard Deviation 1.8 |
| RT-CGM | Short Food Questionnaire | 5.7 score on a scale | Standard Deviation 1.8 |
Secondary
Shoulder Dystocia
number with shoulder dystocia at delivery
Time frame: delivery
Population: data of participants with delivery data available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Shoulder Dystocia | 0 Participants |
| RT-CGM | Shoulder Dystocia | 0 Participants |
Secondary
TAB CGM GDM
Time above range, 140 mg/dL threshold (TAR140)
Time frame: 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | TAB CGM GDM | 6.4 % of time | Standard Deviation 8.5 |
| RT-CGM | TAB CGM GDM | 7.1 % of time | Standard Deviation 8 |
Secondary
TBR CGM GDM
Time below range, 63 mg/dL threshold (TBR63) GDM
Time frame: 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | TBR CGM GDM | 1.5 % of time | Standard Deviation 1.9 |
| RT-CGM | TBR CGM GDM | 0.4 % of time | Standard Deviation 0.5 |
Secondary
Type of Labor
Labor Status on Admission -(induced, spontaneous, planned c-section
Time frame: delivery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Type of Labor | induced | 2 Participants |
| Blinded Continuous Glucose Monitoring Devise | Type of Labor | spontaneous | 11 Participants |
| Blinded Continuous Glucose Monitoring Devise | Type of Labor | planned c-section | 8 Participants |
| RT-CGM | Type of Labor | induced | 9 Participants |
| RT-CGM | Type of Labor | spontaneous | 21 Participants |
| RT-CGM | Type of Labor | planned c-section | 14 Participants |
Secondary
Walking Time Physcial Active Questionnaire
% of participants walking greater than 10 minutes or more per day
Time frame: 36 weeks
Population: over those that answered the physical activity survey
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | Walking Time Physcial Active Questionnaire | 95 percentage of participants |
| RT-CGM | Walking Time Physcial Active Questionnaire | 100 percentage of participants |
Secondary
WHO QOL Scale
World health organization Quality of Life survey Possible scores range from 0 to 25 with higher scores indicating more happiness or contentment.
Time frame: 36 weeks
Population: of those that answered the QOL survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blinded Continuous Glucose Monitoring Devise | WHO QOL Scale | 16.2 units on a scale | Standard Deviation 3.6 |
| RT-CGM | WHO QOL Scale | 15.3 units on a scale | Standard Deviation 3.6 |