Abstract text (incl. figure legends and references)

Question:

Migraine is a headache disorder associated with a high socioeconomic burden. We developed a digital therapeutic that provides an individualized low-glycemic diet based on continuous glucose measurement. We aimed to find out if this digital therapeutic can serve as a non-pharmacological migraine prophylaxis.

Methods:

We have performed two prospective studies with migraine patients who used our digital therapeutic over a period of 16 weeks. The patients used a headache diary and recorded their migraine-related daily life impairment using the assessment tools HIT-6 and MIDAS for a pre versus post comparison. In addition, continuous glucose data of patients were compared to healthy controls.

Results:

In both studies, patients reported a reduction of headache and migraine days as well as reductions in HIT-6 and MIDAS scores. More specifically, migraine days decreased by 2.40 days (95 % CI [-3.37; -1.42]), HIT-6 improved by 3.17 points (95 % CI [-4.63; -1.70]) and MIDAS by 13.45 points (95 % CI [-22.01; -4.89]). Glucose data suggest that migraine patients have slightly increased mean glucose values as compared to healthy controls but drop into a glucose range that is below one"s individual standard range before a migraine attack.

Conclusion:

In conclusion, our digital therapeutic is a non-pharmacological migraine prophylaxis that induces a therapeutic effect within the range of pharmacological interventions.