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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control : Blinded Continuous Glucose Monitoring (CGM) | No Intervention | If you are in the control group, you will wear a continuous glucose monitor but it will be blinded during pregnancy. | |
| Intervention: Real Time -Continuous Glucose Monitoring (RT-CGM) | Active Comparator | Wearing RT- CGM during pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose | mean glucose CGM | 36 weeks |
| TIR CGM | Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Birthweight | Birth weight [grams; mean (SD)] | delivery |
| TBR CGM GDM | Time below range, 63 mg/dL threshold (TBR63) GDM | 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
A female who is pregnant
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| Name | Affiliation | Role |
|---|---|---|
| Nicole M Ehrhardt, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | RT CGM Intervention Group | Real time continuous glucose monitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blinded CGM | Blinded Continuous monitoring device |
| BG001 | RT- CGM | Real time Continuous monitoring device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Glucose | mean glucose CGM | Participants with > 3 days of CGM data available at 36 weeks EGA | Posted | Mean | Standard Deviation | mg/dl | 36 weeks |
|
3 to 6.5 months(duration of pregnancy)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blinded CGM | Blinded Continuous monitoring device | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding or irritation at device site | Skin and subcutaneous tissue disorders | Systematic Assessment | minor bleeding or irritation at device site |
high dropout rate/withdrawal immediately after randomization leading to lower number of subject analysis. Unreliable data given reporting in EMR varied for certain metrics for maternal/fetal outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr, Nicole Ehrhardt | university of Washington Diabetes Institute | 2404479566 | nehrhard@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2024 | Jan 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 20, 2022 | Oct 16, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Real- time continuous glucose monitoring using the DexCom G6.
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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.
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|
| TAB CGM GDM | Time above range, 140 mg/dL threshold (TAR140) | 36 weeks |
| MAGE CGM | Mean Amplitude of glycemic excursions (MAGE) continuous glucoe monitoring | 36 weeks |
| SD CGM | standard deviation Continuous glucose monitoring | 36 weeks |
| 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. | 36 weeks |
| Neonatal Hypoglycemia | number(%) <40mg/dl of neonatal hypoglycemia | delivery |
| Gestational Age at Delivery | gestational age at delivery weeks mean (sd) | delivery |
| Mode of Delivery | mode of deliver reported ( vaginal, c-section, operative vaginal) | delivery |
| Type of Labor | Labor Status on Admission -(induced, spontaneous, planned c-section | delivery |
| Shoulder Dystocia | number with shoulder dystocia at delivery | delivery |
| Preeclampsia or HTN | Preeclampsia or Gestational hypertension (HTN ) | delivery |
| Maternal Weight Gain | Maternal weight gain [lbs; mean (SD)] at delivery | delivery |
| Diabetes Medication Use | use of metformin and insulin in pregnancy | at 36 weeks |
| 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 | delivery |
| Live Birth or Stillbirth | live birth or still birth at delivery | devlivery |
| 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. | delivery |
| NICU Admission | Need for neonatal intensive care admission | delivery |
| Neonatal Complications | neonatal respiratory distress, birth injury, hypoxic encephalopathy | delivery |
| Glucose Meter Fingerstick Per Day | mean number of fingersticks per day by 36 weeks | 36 weeks |
| Mean Days of RT-CGM Use | Mean (SD) days of RT-CGM use | 36 weeks |
| A1c | A1c at 36 weeks | 36 weeks |
| Fructosamine | frucosamine at 36 weeks | 36 weeks |
| 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 | 36 weeks |
| 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. | 36 weeks |
| Diabetes Distress(PAID) Survey | 5 items diabetes distress score Possible total score ranges from 0 to 20. Higher scores indicate more emotional distress. | 36 weeks |
| Walking Time Physcial Active Questionnaire | % of participants walking greater than 10 minutes or more per day | 36 weeks |
| Metformin Only Use | use of metformin only | at 36 weeks |
| Insulin Use Only | use of insulin only | at 36 weeks |
| Insulin Use Only | use of insulin only | at delivery |
| Diabetes Medication Use Delivery | use of metformin and insulin in pregnancy | at delivery |
| Metformin Use Only at Delivery | use of metformin only at time of delivery | at delivery |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
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| Primary | TIR CGM | Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring | Participants with > 3 days of CGM data at 36 weeks EGA | Posted | Mean | Standard Deviation | % of time | 36 weeks |
|
|
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| Secondary | Fetal Birthweight | Birth weight [grams; mean (SD)] | fetal live births with data available from hospital record or 1 self reported | Posted | Mean | Standard Deviation | grams | delivery |
|
|
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| Secondary | TBR CGM GDM | Time below range, 63 mg/dL threshold (TBR63) GDM | Posted | Mean | Standard Deviation | % of time | 36 weeks |
|
|
|
| Secondary | TAB CGM GDM | Time above range, 140 mg/dL threshold (TAR140) | Posted | Mean | Standard Deviation | % of time | 36 weeks |
|
|
|
| Secondary | MAGE CGM | Mean Amplitude of glycemic excursions (MAGE) continuous glucoe monitoring | Posted | Mean | Standard Deviation | mg/dl | 36 weeks |
|
|
|
| Secondary | SD CGM | standard deviation Continuous glucose monitoring | Posted | Mean | Standard Deviation | mg/dl | 36 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of variation | 36 weeks |
|
|
|
| Secondary | Neonatal Hypoglycemia | number(%) <40mg/dl of neonatal hypoglycemia | in livebirths with glucose available in the electronic medical record | Posted | Count of Participants | Participants | delivery |
|
|
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| Secondary | Gestational Age at Delivery | gestational age at delivery weeks mean (sd) | gestational age of participants with data available | Posted | Mean | Standard Deviation | total time in weeks | delivery |
|
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| Secondary | Mode of Delivery | mode of deliver reported ( vaginal, c-section, operative vaginal) | participants with data available for mode of delivery | Posted | Count of Participants | Participants | delivery |
|
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| Secondary | Type of Labor | Labor Status on Admission -(induced, spontaneous, planned c-section | Posted | Count of Participants | Participants | delivery |
|
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| Secondary | Shoulder Dystocia | number with shoulder dystocia at delivery | data of participants with delivery data available | Posted | Count of Participants | Participants | delivery |
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| Secondary | Preeclampsia or HTN | Preeclampsia or Gestational hypertension (HTN ) | Posted | Count of Participants | Participants | delivery |
|
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| Secondary | Maternal Weight Gain | Maternal weight gain [lbs; mean (SD)] at delivery | Participants with weight gain data at delivery, some missing data | Posted | Mean | Standard Deviation | pounds | delivery |
|
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| Secondary | Diabetes Medication Use | use of metformin and insulin in pregnancy | all participants who completed | Posted | Count of Participants | Participants | at 36 weeks |
|
|
|
| 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 | of patient's baby's with data available at delivery some missing data | Posted | Mean | Standard Deviation | units on a scale | delivery |
|
|
|
| Secondary | Live Birth or Stillbirth | live birth or still birth at delivery | with EMR data available about delivery or self reported | Posted | Count of Participants | Participants | devlivery |
|
|
|
| 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. | of participant that had birthweights available at birth and gestational age at delivery, | Posted | Mean | Standard Deviation | ratio | delivery |
|
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| Secondary | NICU Admission | Need for neonatal intensive care admission | of data available at delivery some data missing as delivered at outside hospital without record accesss or by self-report by participant | Posted | Number | participants' infant | delivery |
|
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| Secondary | Neonatal Complications | neonatal respiratory distress, birth injury, hypoxic encephalopathy | fetal data available on EMR review some data not available as delivered outside source | Posted | Count of Participants | Participants | delivery |
|
|
|
| Secondary | Glucose Meter Fingerstick Per Day | mean number of fingersticks per day by 36 weeks | participants with fingerstick data available at 36 weeks EGA ; some missing data as participants did not provide glucose meter data | Posted | Mean | Standard Deviation | fingersticks per day | 36 weeks |
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| Secondary | Mean Days of RT-CGM Use | Mean (SD) days of RT-CGM use | Posted | Mean | Standard Deviation | days worn | 36 weeks |
|
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| Secondary | A1c | A1c at 36 weeks | participants with A1c at 36 weeks some missing data | Posted | Mean | Standard Deviation | % of A1c | 36 weeks |
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| Secondary | Fructosamine | frucosamine at 36 weeks | participants with fructoasmine data at 36 weeks Some missing data | Posted | Mean | Standard Deviation | umol/L | 36 weeks |
|
|
|
| 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 | of those that answered the short food question survey | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
|
|
| 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. | of those that answered the QOL survey | Posted | Mean | Standard Deviation | units on a scale | 36 weeks |
|
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|
| Secondary | Diabetes Distress(PAID) Survey | 5 items diabetes distress score Possible total score ranges from 0 to 20. Higher scores indicate more emotional distress. | of those that answered the paid survey | Posted | Mean | Standard Deviation | score on a scale | 36 weeks |
|
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| Secondary | Walking Time Physcial Active Questionnaire | % of participants walking greater than 10 minutes or more per day | over those that answered the physical activity survey | Posted | Number | percentage of participants | 36 weeks |
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| Secondary | Metformin Only Use | use of metformin only | all participants who completed | Posted | Count of Participants | Participants | at 36 weeks |
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| Secondary | Insulin Use Only | use of insulin only | all participants who completed | Posted | Count of Participants | Participants | at 36 weeks |
|
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| Secondary | Insulin Use Only | use of insulin only | all participants who completed | Posted | Count of Participants | Participants | at delivery |
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| Secondary | Diabetes Medication Use Delivery | use of metformin and insulin in pregnancy | all participants who completed | Posted | Count of Participants | Participants | at delivery |
|
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| Secondary | Metformin Use Only at Delivery | use of metformin only at time of delivery | all participants who completed | Posted | Count of Participants | Participants | at delivery |
|
|
|
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | RT- CGM | Real time Continuous monitoring device | 0 | 48 | 0 | 48 | 3 | 48 |
|
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| operative vaginal |
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| planned c-section |
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| hypoxic encephalopathy |
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| none |
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