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

NCT03935191 | Unknown FDA Device

• 1 other identifier: PTL-903652
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Dexcom G6 CGM Accuracy

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

  10 days

Secondary Outcomes (1)

• Dexcom G6 CGM Safety

  10 days

Study Arms (1)

Group

Device: Dexcom CGM System

Device: Dexcom CGM System

Interventions

Dexcom CGM System DEVICE

Dexcom CGM System

Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

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

You may not qualify if:

• 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;
• Known allergy to medical-grade adhesives;
• Hematocrit of \< 30%;
• 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;
• Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period;
• Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period;
• 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.);
• 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);
• 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).

Sponsors & Collaborators

• DexCom, Inc.: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stayce Beck

  DexCom, Inc.

  STUDY DIRECTOR

Central Study Contacts

Cynthia Makady

CONTACT

858-200-0272; cmakady@dexcom.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: May 1, 2019
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share