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

Abstract

Migraine is a headache disorder associated with a high socioeconomic burden. The digital therapeutic sinCephalea provides an individualized low-glycemic diet based on continuous glucose measurement and is intended to provide a non-pharmacological migraine prophylaxis. We performed two prospective studies with migraine patients who used sinCephalea over a period of 16 weeks. The patients used a headache diary and recorded their migraine-related daily life impairments 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. 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 compared to healthy controls, but drop into a glucose range that is below one’s individual standard range before a migraine attack. In conclusion, sinCephalea is a non-pharmacological, digital migraine prophylaxis that induces a therapeutic effect within the range of pharmacological interventions.

Digital Therapeutics in Migraine Management: A Novel Treatment Option in the COVID-19 Era

“… 40 Lelleck et al 2022 Prospective observational study sinCephalea 49 sinCephalea (a non-pharmacological digital migraine prophylaxis) induced therapeutic effects within the range of pharmacological interventions. 39 Buse et al 2022 Two-arm observational study GIER & REN 170 Combining guided intervention of education and relaxation with remote electrical neuromodulation (REN) treatment can improve therapeutic efficacy beyond that of REN alone. 29 Ailani et al 2022 Real-World Analysis REN 12,368 The real-world clinical data indicates that remote electrical neuromodulation (REN) provides an efficacious, stable, and safe treatment option for acute migraine, both as a standalone replacement of pharmaceuticals, as well as an adjunct to medications.…”

“… 38 In addition, a prospective observational study revealed that a non-pharmacological digital migraine prophylaxis tool, sinCephalea, induced therapeutic effects within a range of pharmacological interventions. 39 In addition to dCBT, a retrospective cohort study suggested that an individualized low-glycemic diet intervention combined with continuous online glucose measurement could be a promising approach for migraine prophylaxis 40 ( Table 1 ).…”

Diet and migraine: what is proven?

“…A new study [51 ▪ ] provided data that an individualized low-glycemic diet can serve as a nonpharmacological migraine prophylaxis. LGIT (low glycemic index diet) is characterized by a higher amount of carbohydrates (60–80 g per day) from low-glycemic-index sources.…”

“…In both studies, over 16 weeks, patients reported a reduction in headache and migraine days and reductions in HIT-6 and MIDAS (Migraine Disability Assessment) scores. It seems that digital therapeutics, such as sinCephalea, can provide benefits [51 ▪ ,52]. Education and monitoring of patients via mobile applications [53] have also been presented as useful tools in migraine clinical care.…”

From Data to Insight: Predicting Interstitial Glucose in Healthy Cohort with Non-invasive Sensor Technology and Machine Learning

“…Therefore, personalized nutritional concepts based on PPGR have been shown to be more beneficial than the Mediterranean diet, which is the current gold standard in the nutritional management of prediabetes and T2D 14 , and the equivalent of a low-fat diet in the management of obesity 15 . Using a digital pharmacological approach, the prospective data of a personalized low-glycemic diet point to a therapeutic benefit in preventing migraine attacks 16 . This highlights the wide range of applications of digital low-glycemic dietary strategies not only in diabetes management.…”