Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 28 for:    dexcom | Not yet recruiting Studies
Previous Study | Return to List | Next Study

Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

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: NCT03935191
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.

Brief Summary:
The purpose of this prospective observational study is to establish the performance and safety of the Dexcom G6 CGM System utilized for up to a 10-day wear period in pregnant women with diabetes mellitus.

Condition or disease Intervention/treatment
Diabetes Device: Dexcom CGM System

Detailed Description:

Primary Study Objective:

To determine the accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus.

Secondary Study Objective:

To assess the safety of the Dexcom G6 CGM System, through characterization of device-related Adverse Events (AEs), in pregnant women with diabetes mellitus.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Group/Cohort Intervention/treatment
Group
Device: Dexcom CGM System
Device: Dexcom CGM System
Dexcom CGM System




Primary Outcome Measures :
  1. Dexcom G6 CGM Accuracy [ Time Frame: 10 days ]
    Accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus.


Secondary Outcome Measures :
  1. Dexcom G6 CGM Safety [ Time Frame: 10 days ]
    Assess the safety of the Dexcom G6 CGM System, through characterization of device-related Adverse Events (AEs), in pregnant women with diabetes mellitus.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Age ≥ 18 years;
  2. Currently in the 2nd or 3rd trimester of pregnancy;
  3. Diagnosis of GDM, T1DM, or T2DM;
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Currently in the 2nd or 3rd trimester of pregnancy;
  3. Diagnosis of GDM, T1DM, or T2DM;
  4. Willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site;
  5. Able to follow study procedures;
  6. Able to speak, read, and write in English or Spanish.

Exclusion Criteria:

  1. Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
  2. Known allergy to medical-grade adhesives;
  3. Hematocrit of < 30%;
  4. Prescribed tocolytic drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications, including, but not limited to, pre-eclampsia or HELLP syndrome (hemolysis, elevated liver enzymes, and a low platelet count) during current pregnancy;
  5. Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period;
  6. Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period;
  7. Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study.);
  8. Working for a competitive medical device company or having an immediate family member or person living within the same household who works for such a company (e.g., Medtronic, GlySens Inc., Abbott Laboratories, Roche, Senseonics, Waveform, and Ascencia/POCTech);
  9. Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual impairment) or pose excessive risk to study staff handling venous blood samples (e.g., known history of HIV or Hepatitis B or C).

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): NCT03935191


Contacts
Layout table for location contacts
Contact: Cynthia Makady 858-200-0272 cmakady@dexcom.com

Sponsors and Collaborators
DexCom, Inc.
Investigators
Layout table for investigator information
Study Director: Stayce Beck DexCom, Inc.
Layout table for additonal information
Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT03935191    
Other Study ID Numbers: PTL-903652
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases