Trial results for a neuromodulation study in Type 2 Diabetes were posted on 2025-06-06, indicating the study was terminated after enrolling only 6 participants.
Background
Type 2 Diabetes is a chronic metabolic disorder characterized by high blood sugar, insulin resistance, and relative lack of insulin. It is a major global health concern, often managed through lifestyle modifications, oral medications, and sometimes insulin therapy. The search for novel therapeutic approaches continues, including exploring neuromodulation as a potential intervention to improve glucose metabolism.
Trial design
This study, designated as Phase NA, was an open-label, proof-of-concept investigation that was ultimately TERMINATED. It enrolled 6 participants with Type 2 Diabetes. The trial was designed with a single active treatment arm to assess the effects of CVS-based stimulation. The primary outcome measure was defined as a difference between pre and post-treatment A1c.
What this means
The termination of this proof-of-concept study after enrolling only 6 participants means that no conclusions can be drawn regarding the efficacy or safety of CVS-based stimulation for Type 2 Diabetes from these trial results. The study's early termination prevents any assessment of its primary outcome measure, a difference between pre and post-treatment A1c. Further research would be needed to explore the potential of neuromodulation in this context.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02130401, titled "Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes", were posted on 2025-06-06 on clinicaltrials.gov.