Comment on “Patient-Led Insulin Titration for Glycemic Management With Gestational Diabetes Mellitus: A Randomized Controlled Trial”

Gestational diabetes mellitus (GDM) affects nearly 10% of pregnancies in the United States and is associated with adverse pregnancy, maternal, and child outcomes. Improved glycemic control reduces these risks, and to achieve this, more than one fourth of patients require pharmacotherapy, such as insulin. While guidelines define when medication should be started and what glucose targets should be targeted, they give limited guidance on dose titration. Clinician-led titration remains the standard of care, but up to one third of patients managed this way do not achieve euglycemia by delivery. Patient-led insulin titration has improved glycemic control in nonpregnant patients with type 2 diabetes, but data in GDM remain limited. This randomized controlled trial evaluated whether patient-led insulin titration improved glycemic management, pregnancy outcomes, and patient-reported outcomes compared with clinician-led titration.

This nonblinded randomized controlled trial enrolled patients from an integrated prenatal and diabetes care program at a tertiary hospital between 2023 and 2025. Eligible patients were between 20 and 31+6 weeks’ gestation, with GDM requiring nightly basal insulin. Patients taking at least 2000 mg of metformin pre-enrollment were counseled to continue this in addition to insulin. Participants were randomized to either daily patient-led titration or standard clinician-led weekly titration through glucose log review. In the intervention group, participants began with 10 units of nighttime basal insulin and adjusted the dose by 2 units each day based on the most recent fasting glucose. Both groups continued routine diabetes care, weekly glucose log review, and monthly ultrasound assessment. The primary outcome was the mean fasting glucose in the 36th week. Secondary outcomes included other glycemic measures, insulin dose, maternal and neonatal outcomes, and patient-reported measures. All outcome analysis was based on an intention-to-treat approach.

A total of 56 participants were randomized, with 29 assigned to patient-led titration and 27 to clinician-led titration. Baseline characteristics were generally similar, though the patient-led group had lower educational attainment and was more likely to be parous with previous GDM. Mean fasting glucose before delivery was similar between groups (88.8 vs. 90.3 mg/dL), but patient-led titration achieved target fasting glucose more quickly than clinician-led titration, with a mean time to fasting glucose below 95 mg/dL of 1.8 versus 2.5 weeks, respectively (HR: 1.48, 95% CI: 1.16-1.90). Secondary glycemic targets and patient-reported outcomes were similar. Patient-led titration was associated with lower rates of macrosomia (6.9% vs. 37.0%) and large-for-gestational-age birth weight (3.3% vs. 34.6%), while other maternal and neonatal outcomes were comparable.

Patient-led insulin titration did not lower fasting glucose before delivery compared with clinician-led titration, but it was associated with faster achievement of fasting glucose target and lower rates of fetal overgrowth. Treatment satisfaction, diabetes distress, self-efficacy, and clinician-patient communication were high and similar between groups. Study strengths include the simple, low-cost intervention and standardized assessment of patient-reported outcomes. This study was limited by the small sample size, which was not developed to detect differences in clinical outcomes. Other limitations include the single-center design, socioeconomic differences in the study population, and standard care that may not reflect all obstetric practices. Overall, patient-led titration appears feasible and may improve selected glycemic and neonatal outcomes, though larger multicenter studies are needed.

(Summarized from Wang XY, Grobman WA, Wu J, et al Patient-led insulin titration for glycemic management with gestational diabetes mellitus: a randomized controlled trial. Obstet Gynecol. 2026;00:1–9. doi:10.1097/AOG.0000000000006154).