| Condition or disease | Intervention/treatment |
|---|---|
| Diabetes | Device: Dexcom CGM System |
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 |
| 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
|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Cynthia Makady | 858-200-0272 | cmakady@dexcom.com |
| 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 |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures |
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. |
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| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population |
|
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| Condition | Diabetes | ||||||
| Intervention | Device: Dexcom CGM System
Dexcom CGM System
|
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| Study Groups/Cohorts | Group
Device: Dexcom CGM System
Intervention: Device: Dexcom CGM System
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Unknown status | ||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | DexCom, Inc. | ||||||
| Study Sponsor | DexCom, Inc. | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
|
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| PRS Account | DexCom, Inc. | ||||||
| Verification Date | April 2019 | ||||||