Possible Glycemic Effects of Vagus Nerve Stimulation Evaluated by Continuous Glucose Monitoring in People with Diabetes and Autonomic Neuropathy: A Randomized, Sham-Controlled Trial
Authors' conclusion
Overall, no significant changes were observed in CGM metrics between treatment arms, while individuals with T1D and DAN decreased their CV after 8 weeks of tVNS treatment.
Study context
- Population
- Individuals with T1D or T2D and diabetic autonomic neuropathyContinuous glucose monitoring (CGM) measured for 104 · Individuals with T1D 70 · or T2D 75
- Participants
- 145 individuals
- Comparison
- Active cervical transcutaneous vagus nerve stimulation (tVNS) vs sham
- Activen = 68
- Shamn = 77reference
- Primary endpoint
- Between-group differences in changes in CV and in TIR 3.9-10 mmol/L (CGM)
- Follow-up
- 1-week and 8-week periods
Methodological detailssham-controlled, self-administered
- Sham-controlled
- Self-administered
Primary result
As reported in the abstract
Change in CV · 1-week period
Active
−1.1
median · IQR −4.3–2.0 · %
Sham
−1.5
median · IQR −4.4–2.5 · %
P = 0.54
Secondary outcomes
| Outcome | Estimated treatment effect (%) (95% CI) | P value |
|---|---|---|
| Change in CV, T1D subgroup · 8 weeksSignificant reduction with active tVNS · subgroup analysis | −11.6 (−20.2 to −2.0) | P = 0.009 |
Other CGM metrics and HbA1c
- None of the changes in secondary outcomes between groups were significantly different
Original publication
Possible Glycemic Effects of Vagus Nerve Stimulation Evaluated by Continuous Glucose Monitoring in People with Diabetes and Autonomic Neuropathy: A Randomized, Sham-Controlled Trial. Diabetes Technol Ther. Published 24 October 2024. doi:10. 1089/ dia. 2024. 0175
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