JMIR Publications

ABSTRACT

Background:

Primary care diabetes management lacks objective exercise tracking due to time constraints and reliance on self-report. Segmental multi-frequency bioelectrical impedance analysis (BIA) may provide a low-burden physiologic signal to anticipate near-term glycemic goal attainment.

Objective:

To develop and validate a digital BIA framework for real-time exercise compliance assessment in type 2 diabetes and to evaluate its implementability in routine primary care.

Methods:

We conducted a quasi-experimental, temporally allocated observational study (intention-to-treat n=193) of adults with type 2 diabetes (UMIN000058452; retrospectively registered). Participants were allocated by calendar period to comprehensive (n=65), partial (n=30), or standard care (n=98). Segmental BIA was obtained with an FDA 510(k)-cleared analyzer (InBody 770) across anatomical sites and frequencies; the a priori primary exposure was left-arm 50-kHz reactance. The primary outcome was individualized HbA1c target achievement at 4 months. Prespecified covariates were included; multiplicity across segment×frequency comparisons was controlled with the Benjamini–Hochberg false discovery rate (FDR).

Results:

HbA1c declined across periods with the largest improvement under comprehensive care. Left-arm 50-kHz reactance was associated with HbA1c target achievement after multiplicity control (adjusted P = .044). An interaction with neighborhood walkability (Walk Score) was significant (P = .012), indicating a stronger association in higher-walkability settings. The predictive model showed AUC = 0.847 with 84% accuracy at the Youden-optimal threshold.

Conclusions:

A standardized, segmental BIA measure—particularly left-arm 50-kHz reactance—provides an objective, low-burden tracking signal that aligns with near-term glycemic goal attainment and is feasible for primary-care implementation using widely available, FDA 510(k)-cleared equipment. Prospective multi-site validation is warranted. Clinical Trial: Registry: UMIN Clinical Trials Registry Registration Number: UMIN000058452 (retrospectively registered) Registration URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000066830