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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent & screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postpartum glucose sensor | Other | Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom glucose sensor | Device | Use of a Dexcom G6 Pro |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least 72 Hours of CGM Data Downloaded. | Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded. | Postpartum days 10-20 |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition. Specificity for Time in Range 70-180 mg/dL of <96% for abnormal OGTT is reported. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grenye O'Malley, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Aggregate data will be reported
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Recruitment was conducted from February 2023-January 2024 at a single urban medical center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Postpartum Glucose Sensor | Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test. Dexcom glucose sensor: Use of a Dexcom G6 Pro |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Postpartum Glucose Sensor | Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test. Dexcom glucose sensor: Use of a Dexcom G6 Pro |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least 72 Hours of CGM Data Downloaded. | Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded. | Posted | Count of Participants | Participants | Postpartum days 10-20 |
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|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Postpartum Glucose Sensor | Glucose sensor worn for up to 10 days postpartum and at time of glucose tolerance test. Dexcom glucose sensor: Use of a Dexcom G6 Pro |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grenye O'Malley | Icahn School of Medicine at Mount Sinai | 212-241-7173 | omallg01@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2022 | Feb 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| up to 12 weeks postpartum |
| Sensitivity | Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases. Sensitivity for Time in Range 70-180 mg/dL of <96% for abnormal OGTT is reported. | up to 12 weeks postpartum |
| Positive Predictive Value (PPV) | PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease. Positive predictive value (PPV) of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported. | up to 12 weeks postpartum |
| Positive Likelihood Ratio (PLR) | PLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition. PLR of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported. | up to 12 weeks postpartum |
| Negative Predictive Value (NPV) | NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease. NPV of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported. | up to 12 weeks postpartum |
| Negative Likelihood Ratio (NLR) | NLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition. NLR of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported. | up to 12 weeks postpartum |
| did not complete routine postpartum OGTT |
|
| did not return second CGM sensor |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Pre-pregnancy body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
| Insurance type | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
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| Family history of type 2 diabetes | Count of Participants | Participants |
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| Multigravida | Count of Participants | Participants |
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| Gestational diabetes (GDM) in prior pregnancy | Count of Participants | Participants |
|
| Number of prenatal visits | Mean | Standard Deviation | visits |
|
| GDM management | Count of Participants | Participants |
|
| Hypertensive complications | Count of Participants | Participants |
|
| Delivery type | Count of Participants | Participants |
|
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| Secondary | Specificity | Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition. Specificity for Time in Range 70-180 mg/dL of <96% for abnormal OGTT is reported. | Results for usable data | Posted | Number | percent | up to 12 weeks postpartum |
|
|
|
| Secondary | Sensitivity | Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases. Sensitivity for Time in Range 70-180 mg/dL of <96% for abnormal OGTT is reported. | Results for usable data | Posted | Number | percent | up to 12 weeks postpartum |
|
|
|
| Secondary | Positive Predictive Value (PPV) | PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease. Positive predictive value (PPV) of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported. | Posted | Number | percent | up to 12 weeks postpartum |
|
|
|
| Secondary | Positive Likelihood Ratio (PLR) | PLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition. PLR of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported. | Posted | Number | ratio | up to 12 weeks postpartum |
|
|
|
| Secondary | Negative Predictive Value (NPV) | NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease. NPV of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported. | Posted | Number | percent | up to 12 weeks postpartum |
|
|
|
| Secondary | Negative Likelihood Ratio (NLR) | NLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition. NLR of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported. | Posted | Number | ratio | up to 12 weeks postpartum |
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Second Sensor | Participants given a second sensor at 6 weeks after pregnancy complicated by GDM and worn at home for up to 10 days. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |