Simultaneous Use of Continuous Glucose Monitoring (CGM) Systems and the Remote Electrical Neuromodulation (REN) Wearable for Patients with Comorbid Diabetes and Migraine: An Interventional Single-Arm Compatibility Study.

Background/Objectives: Migraine and diabetes mellitus are highly prevalent chronic diseases, and their comorbidity presents management challenges, particularly when wearable medical technologies are used concurrently. Remote electrical neuromodulation (REN; Nerivio®) is an FDA-cleared non-pharmacological migraine therapy, and continuous glucose monitoring (CGM) systems are widely used in diabetes care. However, the safety and compatibility of simultaneous co-use have not yet been evaluated. This technical compatibility study aimed to assess whether REN operation affects CGM performance or interferes with glucose measurement integrity in diabetic adults. Methods: Twenty-one adults with diabetes using Dexcom G6/G7 or FreeStyle Libre 2/3 participated in a single-arm interventional study. During a 45 min session, participants operated the REN and CGM devices simultaneously on their smartphones, and the REN device was paused three times to compare CGM readings between REN ON and RED OFF conditions. The primary outcome was the mean absolute relative difference (MARDREN ON/OFF), evaluated against a prespecified 5% threshold. Statistical analysis included the Wilcoxon test, with subgroup analysis by the CGM device family. Results: The median MARDREN ON/OFF across all participants was 1.61% (IQR 0.84-2.44%), significantly below the 5% threshold (p < 0.001). All participants achieved MARDREN ON/OFF < 5%. Subgroup analyses were consistent: the median MARDREN ON/OFF was 1.70% (IQR 0.90-2.45%) for Dexcom and 1.05% (IQR 0.83-1.50%) for Abbott. No technical interference, Bluetooth disruptions, missed data transmission, or adverse events were observed. Conclusions: Simultaneous use of Nerivio® REN and CGM systems in adults with diabetes is compatible and safe, with no evidence of interference or significant deviations in glucose readings. These findings support the integrated and reliable use of REN and CGM wearables in adults with diabetes managing comorbid conditions.