Pregnancy and Postpartum CGM in GDM

Icahn School of Medicine at Mount Sinai40 enrolled

Overview

Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). However only 17-60% of women actually have this test performed. This study is to assess continuous glucose monitor data from the third trimester and up to 14 days postpartum to find predictors of postpartum OGTT results.

Those with GDM in current pregnancy using a Dexcom Continuous Glucose Monitoring (CGM) are eligible for enrollment. Participants use their CGM as usual during pregnancy and wear one sensor postpartum. They have their standard of care OGTT performed at around 6 weeks. They then complete a remote questionnaire after OGTT.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gestational Diabetes

Interventions

continuous glucose monitorDEVICE

All participants who wear CGM

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of gestational diabetes during current pregnancy * age 18 or older * prescribed Dexcom G7 Exclusion Criteria: * Pregestational diabetes * known skin adhesive allergy which inhibits ongoing use of CGM * chronic oral steroid use.

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Sensitivity of postpartum TIR <96%

Sensitivity of postpartum time in range (TIR) \<96% to predict dysglycemia on OGTT. Range 70-180 mg/dL. Sensitivity determined by true positives of TIR \<96% and abnormal OGTT and false negatives would be TIR \<96% with normal OGTT.

Time frame: up to 12 weeks postpartum

Secondary Outcomes

Specificity of postpartum TIR <96%

Specificity of postpartum TIR \<96% to predict dysglycemia on OGTT Specificity calculated by true negatives are TIR not \<96% and normal OGTT and false positive are TIR \<96% but normal OGTT results.

Time frame: up to 12 weeks postpartum

Experience survey questionnaire

6 items in non validated questionnaire to be administered remotely. first 5 questions rated on a 5 point likert scale. question 6 asks participant to choose preference between glucose sensor or oral glucose tolerance test. Each question evaluated on its own scored 1 (Strongly disagree) to 5 (Strongly Agree). The questions are not summed.

Time frame: up to 12 weeks postpartum

Central Contacts

Sarah Rancic

CONTACT

212-241-5355 sarah.rancic@mssm.edu

Grenye O'Malley

CONTACT

212-241-7173 grenye.o'malley@mssm.edu

Data from ClinicalTrials.gov

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