Postpartum Continuous Glucose Monitoring (CGM) Study

Not Applicable

Completed

Conditions: Gestational Diabetes

Interventions: Device: Dexcom glucose sensor

Registration Number: NCT05714761

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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 oral glucose tolerance test (OGTT).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Postpartum glucose sensor	Dexcom glucose sensor	Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test.

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least 72 Hours of CGM Data Downloaded.	Postpartum days 10-20	Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.

Secondary Outcome Measures

Name	Time	Method
Specificity	up to 12 weeks postpartum	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.
Sensitivity	up to 12 weeks postpartum	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.
Positive Predictive Value (PPV)	up to 12 weeks postpartum	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.
Positive Likelihood Ratio (PLR)	up to 12 weeks postpartum	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.
Negative Predictive Value (NPV)	up to 12 weeks postpartum	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.
Negative Likelihood Ratio (NLR)	up to 12 weeks postpartum	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.