A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Primary Purpose
Gestational Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous glucose monitor
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- Pregnancy and Gestation < 28 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
Exclusion Criteria:
- 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
- Already receiving continuous glucose monitoring (CGM)
- History of bariatric surgery
- Gestational Age less than 14 weeks -
Sites / Locations
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blinded Continuous Glucose Monitoring Devise
Arm Description
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.
Outcomes
Primary Outcome Measures
Health of mother using CGM to monitor blood glucose during pregnancy
Continuous glucose monitoring in gestational diabetes
Health of baby using delivery and post delivery well baby assessments
Continuous glucose monitoring in gestational diabetes
Secondary Outcome Measures
Full Information
NCT ID
NCT04803357
First Posted
November 29, 2020
Last Updated
November 11, 2022
Sponsor
University of Washington
Collaborators
DexCom, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04803357
Brief Title
A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Official Title
A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
DexCom, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Real- time continuous glucose monitoring using the DexCom G6.
Masking
None (Open Label)
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.
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blinded Continuous Glucose Monitoring Devise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health of mother using CGM to monitor blood glucose during pregnancy
Description
Continuous glucose monitoring in gestational diabetes
Time Frame
4 years
Title
Health of baby using delivery and post delivery well baby assessments
Description
Continuous glucose monitoring in gestational diabetes
Time Frame
4 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
A female who is pregnant
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnancy and Gestation < 28 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
Exclusion Criteria:
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
Already receiving continuous glucose monitoring (CGM)
History of bariatric surgery
Gestational Age less than 14 weeks -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghada Abdalla
Phone
206-543-1836
Email
gdmcgmstudy@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole M Ehrhardt, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghada Abdella
Phone
206-543-1836
Email
gabdalla@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
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