A randomized controlled trial of real-time continuous glucose monitoring (RT-CGM) for self-management of gestational diabetes
Abstract
Background: Gestational diabetes mellitus (GDM) - a risk factor for adverse pregnancy outcomes - is on the rise. Real-time continuous glucose monitoring (RT-CGM) may enhance glucose control during GDM and thereby improve outcomes; however, more data are needed.
Objective: This study aimed to determine if RT-CGM improved glycemic indices in GDM.
Study design: An open-label, randomized controlled trial was conducted with GDM patients diagnosed between 14 and 30 weeks estimated gestational age (EGA), assigning them either to RT-CGM or blinded CGM in addition to self-monitoring of blood glucose (SMBG). This analysis compares CGM metrics for the study groups at EGA of 32 and 36 weeks (± 10 days). The primary outcome was percentage of time in range 63 to 140 mg/dL (TIR) over 24 hours. Secondary outcomes included mean glucose over 10 days and additional CGM indices, HbA1c, diabetes medication usage, satisfaction with CGM, and maternal and fetal outcomes.
Results: 105 participants with GDM were enrolled (RT-CGM [n=53] or blinded CGM [n=52]) Thirty-one of 52 SMBG participants withdrew, with 30 citing desiring RT-CGM. In participants who completed the study, average EGA was 29.8 weeks (SD=2.5) on their first day of CGM wear with average duration of wear of 64.4 days (SD=19.4). TIR 63-140 mg/dL (TIR) was 93.0 (SD=6.7) and 93.7 (SD=6.8) (p=.86) while mean glucose was 106.7 mg/dL (SD=9.0) and 98.1 mg/dL (SD=13.8) for the RT-CGM and SMBG groups (p=.02), respectively. At study completion,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 105 participants or records.
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