Gestational Diabetes
Conditions
Keywords
gestational diabetes, continuous glucose monitor, glucose sensor, oral glucose tolerance test
Brief summary
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.
Detailed description
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.
Interventions
DEVICEcontinuous glucose monitor
All participants who wear CGM
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of postpartum TIR <96% | up to 12 weeks postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of postpartum TIR <96% | up to 12 weeks postpartum | 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. |
| Experience survey questionnaire | up to 12 weeks postpartum | 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. |
Countries
United States
Contacts
CONTACTSarah Rancic
CONTACTGrenye O'Malley
PRINCIPAL_INVESTIGATORGrenye O'Malley, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed