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出境医 / 临床实验 / Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

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

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 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.

Study Design
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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
Arms and Interventions
Group/Cohort 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
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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
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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.
Tracking Information
First Submitted Date April 30, 2019
First Posted Date May 2, 2019
Last Update Posted Date May 2, 2019
Estimated Study Start Date May 1, 2019
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 30, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
Official Title Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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;
Condition Diabetes
Intervention Device: Dexcom CGM System
Dexcom CGM System
Study Groups/Cohorts Group
Device: Dexcom CGM System
Intervention: Device: Dexcom CGM System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 30, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2019
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03935191
Other Study ID Numbers PTL-903652
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party DexCom, Inc.
Study Sponsor DexCom, Inc.
Collaborators Not Provided
Investigators
Study Director: Stayce Beck DexCom, Inc.
PRS Account DexCom, Inc.
Verification Date April 2019