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Trial record 2 of 23 for:    CGM for gestational diabetes

A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04803357
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Nicole Ehrhardt, University of Washington

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Device: Continuous glucose monitor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Actual Study Start Date : April 10, 2021
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Blinded Continuous Glucose Monitoring Devise
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.
Device: Continuous 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.




Primary Outcome Measures :
  1. Health of mother using CGM to monitor blood glucose during pregnancy [ Time Frame: 4 years ]
    Continuous glucose monitoring in gestational diabetes

  2. Health of baby using delivery and post delivery well baby assessments [ Time Frame: 4 years ]
    Continuous glucose monitoring in gestational diabetes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   A female who is pregnant
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pregnancy and Gestation < 28 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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803357


Contacts
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Contact: Ghada Abdalla 206-543-1836 gdmcgmstudy@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Ghada Abdella    206-543-1836    gabdalla@uw.edu   
Sponsors and Collaborators
University of Washington
DexCom, Inc.
Investigators
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Principal Investigator: Nicole M Ehrhardt, MD University of Washington
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Responsible Party: Nicole Ehrhardt, Assistant Professor, School of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT04803357    
Other Study ID Numbers: STUDY00011755
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications