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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Cynthia Makady; Phone Number: 858-200-0272; Email: cmakady@dexcom.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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;

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group; Device: Dexcom CGM System	Device: Dexcom CGM System; Dexcom CGM System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: DexCom, Inc.
• Investigators: Study Director: Stayce Beck, DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): May 31, 2019
• Study Completion (Anticipated): May 31, 2019

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: PTL-903652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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