A Digital Health Application Allowing a Personalized Low-Glycemic Nutrition for the Prophylaxis of Migraine: Proof-of-Concept Data from a Retrospective Cohort Study

Abstract

Background: Migraine is a headache disorder with the highest socioeconomic burden. The aim of this study was to deliver the first proof-of-concept data of the potential role of an individual low-glycemic diet provided by a novel digital health application in the prophylaxis of migraine. Methods: We analyzed data from a retrospective survey of individuals who participated in a digital nutrition program that provides dietary recommendations based on the individual analysis of continuous glucose measurement from an up to 14-day test phase. A total of 84 individuals completed the retrospective digital survey. The endpoints were changes in the number of migraine days, average duration of attacks, average pain severity, frequency of intake of pain medication, absenteeism, and presenteeism before and after program participation. Results: The intraindividual comparisons of the endpoints before and after program participation revealed decreases in migraine frequency and other patient-relevant migraine parameters. Moreover, patients with a baseline migraine frequency of two and more migraine days per month and adherence to the dietary recommendations (n = 40) showed a mean reduction in migraine days by 33% with a 50%-responder rate of 38%. Conclusions: The data provides emerging evidence that an individualized low-glycemic diet based on continuous glucose measurement could be a promising approach for a diet-based, non-pharmacological migraine prophylaxis. However, future research is required to confirm the implied effectiveness.

A Digital Therapeutic Allowing a Personalized Low-Glycemic Nutrition for the Prophylaxis of Migraine: Real World Data from Two Prospective Studies

“…For example, the National Headache Foundation [ 54 ], the American Migraine Foundation [ 55 , 56 ] and the German Migraine and Headache Society [ 57 ] published dietary recommendations for migraine patients. The importance of nutritional adjustments is the subject of various clinical studies and review papers on which these recommendations are based [ 25 , 26 , 27 , 35 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 ].…”

“…sinCephalea creates personalized nutritional recommendations for a low-glycemic diet. The starting point for the development of sinCephealea was the finding from our own research lab that migraine patients reported noteworthy clinical improvements after receiving low-glycemic diet recommendations outside of a clinical study setting [ 27 ].…”

“…The dietary and glucose data was collected as part of a digital nutrition program of Perfood GmbH, in which the participants voluntarily consented to anonymous data analysis. This data is not yet published; however, the digital nutrition program is described elsewhere [ 27 ].…”

“…This is further supported by an analysis conducted as part of the medical device development of sinCephalea, which showed clear signs of efficacy of a personalized low-glycemic approach. In addition, the analysis revealed an increasing interest among migraine patients in a specific nutritional therapy as an alternative to drug therapies with unfavorable side effect profiles [ 27 ]. The digital therapeutic (DTx) sinCephalea is designed to take into account that postprandial blood glucose metabolism is regulated differently inter-individually, and that dietary recommendations to ensure sustained low blood glucose levels must be personalized based on individual blood glucose metabolism [ 27 , 28 , 29 , 30 , 31 ].…”

“…In addition, the analysis revealed an increasing interest among migraine patients in a specific nutritional therapy as an alternative to drug therapies with unfavorable side effect profiles [ 27 ]. The digital therapeutic (DTx) sinCephalea is designed to take into account that postprandial blood glucose metabolism is regulated differently inter-individually, and that dietary recommendations to ensure sustained low blood glucose levels must be personalized based on individual blood glucose metabolism [ 27 , 28 , 29 , 30 , 31 ]. sinCephalea uses the concept of a personalized low-glycemic diet and enables applicability through digital personalization.…”