BIG IDEAs Lab Glycemic Variability and Wearable Device Data

This study aimed to determine the feasibility and effectiveness of wearable
devices in detecting early physiological changes prior to the development of
prediabetes [1-3]. The study generated digital biomarkers for remote, mHealth-
based prediabetes and hyperglycemia risk to classify which individuals should
undergo further clinical testing. The primary inclusion criteria were subjects
aged 35-65 years, inclusive, including only post-menopausal females, with a
point of care A1C measurement between 5.2-6.4%, inclusive. Blood was collected
during the study for measurement of glucose, hemoglobin A1C, lipoproteins, and
triglycerides. Participants wore a Dexcom 6 continuous glucose monitor (CGM)
and an Empatica E4 wristband for 10 days while receiving a standardized
breakfast meal every other day. At the end of the 10 days, the participant
returned to the clinic for an oral glucose tolerance test (OGTT). Research
data collected includes physiological measurements from wearable devices such
as heart rate, accelerometry, and electrodermal conductance.