Previously submitted to: JMIR Diabetes (no longer under consideration since Nov 25, 2025)
Date Submitted: Nov 13, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Simultaneous Use of Continuous Glucose Monitoring Systems and the Remote Electrical Neuromodulation Wearable for Patients with Comorbid Diabetes and Migraine: Interventional Single Arm Compatibility Study
ABSTRACT
Background:
Migraine and diabetes mellitus are two highly prevalent chronic diseases, affecting millions in the USA and worldwide. Comorbidity presents therapeutic challenges, particularly when pharmacological treatments raise metabolic risks or complications. Remote Electrical Neuromodulation (REN) devices, such as Nerivio® and Continuous Glucose Monitoring (CGM) systems enable patient-centered management through connected, wearable technology, yet their simultaneous use has not been evaluated for safety and performance
Objective:
The study assessed the compatibility and safety of simultaneous operation of the Nerivio® REN wearable device with the most widely used CGM systems in the USA, focusing on device non-interference and functional integrity of glucose measurement.
Methods:
An interventional single-arm study enrolled 21 adults with diabetes who were active CGM users in the USA. Participants operated both Nerivio® and their usual CGM system app (Dexcom G6/G7 or FreeStyle Libre 2/3) on personal smartphones during REN stimulation. At three paired timepoints during a 45-minute session, CGM measurements were collected with REN ‘ON’ (active) and ‘OFF’ (paused) phases. The primary outcome was the group-level Mean Absolute Relative Difference (MARD) between CGM readings during ON and OFF REN states, with a prespecified threshold of 5% for minimal deviation, based on prior literature and FDA standards. Statistical analysis employed the Wilcoxon test; subgroup analysis examined CGM family.
Results:
All 21 participants (mean age 49.9 + 11.2 years; 52% females) successfully completed the study. The cohort included both type 2 (57%) and type 1 diabetes (43%), representing a diversity of CGM devices and smartphone types. Across all participants, the median MARD between ‘ON’ and ‘OFF’ REN phases was 1.61% (IQR 0.84-2.44%], significantly below the 5% threshold; W=0; z=-4.01; P<.001). All participants achieved MARD<5%, demonstrating minimal deviation from baseline CGM measurements. Device-type subgroup analyses confirmed consistent performance; median MARD was 1.70% (IQR 0.90-2.45%) for Dexcom systems; and 1.05% (IQR 0.83-1.50%) for Abbott systems, both significantly below 5%. No technical interference, Bluetooth disruptions, missed data transmission, or adverse events occurred.
Conclusions:
Simultaneous use of the Nerivio® REN wearable with CGM systems is compatible and safe, with no evidence of interference, deviation in glucose measurements, or other harms or hazards. These findings provide evidence for reliable, integrated use of REN for migraine management in people with comorbid diabetes who use CGM for glycemic control, supporting adoption of multi-device wearable strategies for complex populations. Clinical Trial: WIRB;20252702
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