Pregnancy and Postpartum CGM in GDM
ConditionGestational Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of gestational diabetes during current pregnancy
age 18 or older
prescribed Dexcom G7
Disqualifiers
Pregestational diabetes
known skin adhesive allergy which inhibits ongoing use of CGM
chronic oral steroid use.
Trial population
Diagnosis of gestational diabetes during current pregnancy, age 18 or older, and prescribed Dexcom G7
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
continuous glucose monitor
DeviceAll participants who wear CGM
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Participants with Gestational diabetes GDM1 intervention
Trial outcomes
Primary outcomes
1
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 postpartumSecondary outcomes
1
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 postpartum2
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 postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov