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

  • Clinicaltrials.gov identifier

    NCT03935191

  • Recruitment Status

    Not yet recruiting

  • First Posted

    May 2, 2019

  • Last update posted

    May 2, 2019

Study Description

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:Diabetes
  • Intervention/Treatment: Device: Dexcom CGM System
  • Phase: N/A

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.

Study Design

  • 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 2019
  • Estimated Primary Completion Date: May 2019
  • Estimated Study Completion Date: May 2019

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: Group
Device: Dexcom CGM System
Device: Dexcom CGM System
Dexcom CGM System

Outcome Measures

  • 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.

Eligibility Criteria

  • 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).

Contacts and Locations

Contacts

Contact: Cynthia Makady 858-200-0272 cmakady@dexcom.com

Locations

Sponsors and Collaborators

DexCom, Inc.

Investigators

Study Director: Stayce Beck DexCom, Inc.

More Information

  • Responsible Party: DexCom, Inc.
  • ClinicalTrials.gov Identifier: NCT03935191 History of Changes
  • 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
  • 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.: Yes
  • Additional relevant MeSH terms: Diabetes Mellitus