Gestational DiabetesNCT04803357
A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
A study testing Continuous glucose monitor in people with Gestational Diabetes, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Continuous glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2021to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnancy and Gestation < 30 weeks
- Singleton pregnancy
- Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c)
- Able to read English and completed 6th grade
- 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
Who cannot join
- Pre-gestational Type 1 or Type 2 diabetes.
- Newly diagnosed overt-diabetes in pregnancy [HbA1c ≥ 48 mmol/mol (6.5%), fasting glucose ≥ 7.0 mmol/l, random glucose ≥ 11.1 mmol/l].
- Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM
- Known endogenous/exogenous Cushing's syndrome
- Known chronic infections
- Current use of any oral form of steroid medication
Show all 9Show fewer
- Already receiving continuous glucose monitoring (CGM)
- History of bariatric surgery
- Gestational Age less than 14 weeks -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Continuous glucose monitor
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Glucose
mean glucose CGM
Measured: 36 weeks
TIR CGM
Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring
Measured: 36 weeks
Secondary outcomes (32)
Fetal Birthweight
Birth weight [grams; mean (SD)]
Measured: delivery
TBR CGM GDM
Time below range, 63 mg/dL threshold (TBR63) GDM
Measured: 36 weeks
TAB CGM GDM
Time above range, 140 mg/dL threshold (TAR140)
Measured: 36 weeks
MAGE CGM
Mean Amplitude of glycemic excursions (MAGE) continuous glucoe monitoring
Measured: 36 weeks
SD CGM
standard deviation Continuous glucose monitoring
Measured: 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.
Measured: 36 weeks
Neonatal Hypoglycemia
number(%) <40mg/dl of neonatal hypoglycemia
Measured: delivery
Gestational Age at Delivery
gestational age at delivery weeks mean (sd)
Measured: delivery
Mode of Delivery
mode of deliver reported ( vaginal, c-section, operative vaginal)
Measured: delivery
Type of Labor
Labor Status on Admission -(induced, spontaneous, planned c-section
Measured: delivery
Shoulder Dystocia
number with shoulder dystocia at delivery
Measured: delivery
Preeclampsia or HTN
Preeclampsia or Gestational hypertension (HTN )
Measured: delivery
Maternal Weight Gain
Maternal weight gain [lbs; mean (SD)] at delivery
Measured: delivery
Diabetes Medication Use
use of metformin and insulin in pregnancy
Measured: 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
Measured: delivery
Live Birth or Stillbirth
live birth or still birth at delivery
Measured: 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.
Measured: delivery
NICU Admission
Need for neonatal intensive care admission
Measured: delivery
Neonatal Complications
neonatal respiratory distress, birth injury, hypoxic encephalopathy
Measured: delivery
Glucose Meter Fingerstick Per Day
mean number of fingersticks per day by 36 weeks
Measured: 36 weeks
Mean Days of RT-CGM Use
Mean (SD) days of RT-CGM use
Measured: 36 weeks
A1c
A1c at 36 weeks
Measured: 36 weeks
Fructosamine
frucosamine at 36 weeks
Measured: 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
Measured: 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.
Measured: 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.
Measured: 36 weeks
Walking Time Physcial Active Questionnaire
% of participants walking greater than 10 minutes or more per day
Measured: 36 weeks
Metformin Only Use
use of metformin only
Measured: at 36 weeks
Insulin Use Only
use of insulin only
Measured: at 36 weeks
Insulin Use Only
use of insulin only
Measured: at delivery
Diabetes Medication Use Delivery
use of metformin and insulin in pregnancy
Measured: at delivery
Metformin Use Only at Delivery
use of metformin only at time of delivery
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start10 Apr 2021
- Primary completion1 Oct 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Real- time continuous glucose monitoring using the DexCom G6.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Nicole Ehrhardt, University of Washington
- Investigators
- Nicole M Ehrhardt, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803357
- Sponsor's protocol ID
- STUDY00011755
- Status last verified
- Jun 2025
- First submitted
- 29 Nov 2020
- Last updated
- 25 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT04803357
- Acronym / sponsor ID
- STUDY00011755
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Posted 25 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Real- time continuous glucose monitoring using the DexCom G6.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Continuous glucose monitorWearing RT- CGM during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnancy and Gestation < 30 weeks
- Singleton pregnancy
- Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c)
- Able to read English and completed 6th grade
- 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
Key exclusion criteria (9 listed)
- Pre-gestational Type 1 or Type 2 diabetes.
- Newly diagnosed overt-diabetes in pregnancy [HbA1c ≥ 48 mmol/mol (6.5%), fasting glucose ≥ 7.0 mmol/l, random glucose ≥ 11.1 mmol/l].
- Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM
- Known endogenous/exogenous Cushing's syndrome
- Known chronic infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitorWe 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. | Device | Intervention: Real Time -Continuous Glucose Monitoring (RT-CGM) |
Primary outcome
Mean Glucose
Time frame: 36 weeks
mean glucose CGM
TIR CGM
Time frame: 36 weeks
Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring
32 secondary outcomes
Fetal Birthweight
Time frame: delivery
TBR CGM GDM
Time frame: 36 weeks
TAB CGM GDM
Time frame: 36 weeks
MAGE CGM
Time frame: 36 weeks
SD CGM
Time frame: 36 weeks
CV CGM
Time frame: 36 weeks
Neonatal Hypoglycemia
Time frame: delivery
Gestational Age at Delivery
Time frame: delivery
Mode of Delivery
Time frame: delivery
Type of Labor
Time frame: delivery
Shoulder Dystocia
Time frame: delivery
Preeclampsia or HTN
Time frame: delivery
Maternal Weight Gain
Time frame: delivery
Diabetes Medication Use
Time frame: at 36 weeks
5 Minute Apgar
Time frame: delivery
Live Birth or Stillbirth
Time frame: devlivery
Birthweight Ratio
Time frame: delivery
NICU Admission
Time frame: delivery
Neonatal Complications
Time frame: delivery
Glucose Meter Fingerstick Per Day
Time frame: 36 weeks
Mean Days of RT-CGM Use
Time frame: 36 weeks
A1c
Time frame: 36 weeks
Fructosamine
Time frame: 36 weeks
Short Food Questionnaire
Time frame: 36 weeks
WHO QOL Scale
Time frame: 36 weeks
Diabetes Distress(PAID) Survey
Time frame: 36 weeks
Walking Time Physcial Active Questionnaire
Time frame: 36 weeks
Metformin Only Use
Time frame: at 36 weeks
Insulin Use Only
Time frame: at 36 weeks
Insulin Use Only
Time frame: at delivery
Diabetes Medication Use Delivery
Time frame: at delivery
Metformin Use Only at Delivery
Time frame: at delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole M Ehrhardt, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitor in people with Gestational Diabetes, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Glucose (time frame: 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.