Multicomponent provider–patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes: clinical trial protocol for the ACHIEVE study

Abstract

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

Patient and Provider Perspectives About the Use of Patient-Generated Health Data During Pregnancy: Qualitative Exploratory Study

“…For example, uploading self-reported measures of blood glucose to a patient portal has been associated with improvements in glycemic control in a sample of pregnant and nonpregnant patients [ 13 ], and continuous monitoring of blood glucose has been associated with improved neonatal outcomes [ 46 , 48 ]. Evidence will continue to grow from several ongoing clinical trials on this topic, with the greatest focus of these studies on patient-generated physiologic measurements [ 49 , 50 ].…”

Continuous Glucose Monitoring in Pregnancy

“…A randomized controlled trial is planned to assess whether continuous glucose monitor use in addition to other interventions, including a patient mobile health application, health care professional dashboard, and a community health worker, among government-insured patients with poorly controlled non–insulin-dependent diabetes, as evidenced by Hb A 1C higher than 6.5% before 20 weeks of gestation, is associated with improved glycemic control. 43 Another randomized controlled trial is planned to assess whether the use of real-time continuous glucose monitors among pregnant patients with GDM decreases the rate of LGA newborns, neonatal hypoglycemia, cesarean delivery, and shoulder dystocia. 44…”