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Postpartum Continuous Glucose Monitoring (CGM) Study

Primary Purpose

Gestational Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexcom glucose sensor
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gestational Diabetes focused on measuring gestational diabetes, oral glucose tolerance test, glucose sensor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria: include diagnosis of gestational diabetes during a current or recent pregnancy age 18 or older. Exclusion criteria: include known pregestational diabetes, known skin adhesive allergy which would prevent subject from wearing a CGM, chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Postpartum glucose sensor

Arm Description

Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test.

Outcomes

Primary Outcome Measures

Percentage of participants with at least 72 hours of CGM data downloaded.
Percentage of participants with at least 72 hours of CGM data downloaded.

Secondary Outcome Measures

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 proportion of people who test negative among all those who actually do not have that disease.
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 proportion of people who test positive among all those who actually have the disease.
Positive predictive value
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.
Negative predictive value
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.

Full Information

First Posted
January 27, 2023
Last Updated
March 3, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05714761
Brief Title
Postpartum Continuous Glucose Monitoring (CGM) Study
Official Title
Postpartum Dysglycemia Screening With Continuous Glucose Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 OGTT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
gestational diabetes, oral glucose tolerance test, glucose sensor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postpartum glucose sensor
Arm Type
Other
Arm Description
Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test.
Intervention Type
Device
Intervention Name(s)
Dexcom glucose sensor
Intervention Description
Use of a Dexcom G6 Pro
Primary Outcome Measure Information:
Title
Percentage of participants with at least 72 hours of CGM data downloaded.
Description
Percentage of participants with at least 72 hours of CGM data downloaded.
Time Frame
End of study, at 12 months
Secondary Outcome Measure Information:
Title
Specificity
Description
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 proportion of people who test negative among all those who actually do not have that disease.
Time Frame
End of study, at 12 months
Title
Sensitivity
Description
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 proportion of people who test positive among all those who actually have the disease.
Time Frame
End of study, at 12 months
Title
Positive predictive value
Description
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.
Time Frame
End of study, at 12 months
Title
Negative predictive value
Description
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.
Time Frame
End of study, at 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: include diagnosis of gestational diabetes during a current or recent pregnancy age 18 or older. Exclusion criteria: include known pregestational diabetes, known skin adhesive allergy which would prevent subject from wearing a CGM, chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grenye O'Malley, MD
Phone
212-241-7173
Email
grenye.o'malley@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Selassie Ogyaadu, MD
Phone
212-241-9089
Email
selassie.ogyaadu@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grenye O'Malley, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selassie Ogyaadu, MD
Phone
212-241-9089
Email
selassie.ogyaadu@mssm.edu
First Name & Middle Initial & Last Name & Degree
Emily Ellis
Phone
(212) 241-5355
Email
Emily.Ellis@mssm.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate data will be reported

Learn more about this trial

Postpartum Continuous Glucose Monitoring (CGM) Study

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