Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. Adherence rates are low (18-61%), impeding initiation of follow-up care to improve diabetes-related outcomes in subsequent pregnancies and long-term.
Detailed description
Continuous glucose monitoring (CGM) is an appealing alternative to the OGTT because it is a low-burden, fully remote, comprehensive assessment of glycemic status. Emerging data suggest that CGM is superior to the OGTT in identifying persistent dysglycemia at 2-5 months postpartum, and preferable to the OGTT among women willing to complete both assessments in the context of a research study. This study proposes a feasibility study of postpartum CGM among patients who do not complete the standard postpartum OGTT. The study will offer CGM in a telehealth (fully remote) context to determine if it can increase adherence to postpartum glycemic screening in real-world settings. This study will (a) evaluate uptake of CGM screening, (b) characterize patients who complete CGM, complete the OGTT, or do not complete screening, and (c) monitor initiation of follow-up care after abnormal results.
Interventions
- Other Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott
Postpartum CGM
Primary outcome measures
- Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients [Time frame: 20 weeks postpartum]
Eligibility criteria
Inclusion criteria
- 12-16 weeks postpartum
- Gestational diabetes Mellitus (GDM) diagnosis in most recent pregnancy
- Oral Glucose Tolerance Test (OGTT) order placed in the medical record
Exclusion criteria
- Pre-gestational diabetes
- Non-English language
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT07332416 · IRB00143138 · P30DK124723