Introduction
Type 2 diabetes (T2D) is one of the most frequent comorbid medical
conditions in pregnancy. Glycaemic control decreases the risk of adverse
pregnancy outcomes for the pregnant individual and infant. Achieving
glycaemic control can be challenging for Medicaid-insured pregnant
individuals who experience a high burden of unmet social needs.
Multifaceted provider–patient-based approaches are needed to improve
glycaemic control in this high-risk pregnant population. Mobile health
(mHealth) applications (app), provider dashboards, continuous glucose
monitoring (CGM) and addressing social needs have been independently
associated with improved glycaemic control in non-pregnant individuals
living with diabetes. The combined effect of these interventions on
glycaemic control among pregnant individuals with T2D remains to be
evaluated.
Methods and analysis
In a two-arm randomised controlled trial, we will examine the
combined effects of a multicomponent provider–patient intervention,
including a patient mHealth app, provider dashboard, CGM, a community
health worker to address non-medical health-related social needs and
team-based care versus the current standard of diabetes and prenatal
care. We will recruit 124 Medicaid-insured pregnant individuals living
with T2D, who are ≤20 weeks of gestation with poor glycaemic control
measured as a haemoglobin A1c ≥ 6.5% assessed within 12 weeks of trial
randomisation or within 12 weeks of enrolling in prenatal care from an
integrated diabetes and prenatal care programme at a tertiary care
academic health system located in the Midwestern USA. We will measure
how many individuals achieve the primary outcome of glycaemic control
measured as an A1c<6.5% by the time of delivery, and secondarily,
adverse pregnancy outcomes; patient-reported outcomes (eg, health and
technology engagement, literacy and comprehension; provider–patient
communication; diabetes self-efficacy; distress, knowledge and beliefs;
social needs referrals and utilisation; medication adherence) and CGM
measures of glycaemic control (in the intervention group).
Ethics and dissemination
The Institutional Review Board at The Ohio State University approved
this study (IRB: 2022H0399; date: 3 June 2023). We plan to submit
manuscripts describing the user-designed methods and will submit the
results of the trial for publication in peer-reviewed journals and
presentations at international scientific meetings.
Trial registration number
NCT05662462