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. 2022 Jul 17;14(14):2927.
doi: 10.3390/nu14142927.

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

Vivian Valeska Lelleck  1 , Franziska Schulz  2 , Oliver Witt  2 , Gianna Kühn  2 , Dominik Klein  2 , Astrid Gendolla  3 , Stefan Evers  4   5 , Charly Gaul  6 , Diamant Thaçi  7 , Christian Sina  1 , Torsten Schröder  1   2
Affiliations

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

Vivian Valeska Lelleck et al. Nutrients. .

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.

Keywords: continuous glucose measurement; digital therapeutic; episodic migraine; headache; low-glycemic diet; low-glycemic index; migraine prophylaxis; nutrition; personalized nutrition; real world data.

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Conflict of interest statement

F.S., O.W., G.K., D.K. and T.S. are/were employed at Perfood GmbH. T.S. and C.S. are co-founders of Perfood GmbH and minority shareholders. A.G., S.E., C.G. and D.T. received consulting fees from Perfood. The views presented in this manuscript are those of the authors and not necessarily those of Perfood GmbH. Good publication practices were followed. C.G. has received honoraria for consulting and lectures within the past three years from Allergan Pharma, Lilly, Novartis Pharma, Hormosan Pharma, Grünenthal, Sanofi-Aventis, Weber & Weber, Lundbeck, Perfood, and TEVA. His research is supported by a grant of the German Research Foundation (DFG). He does not hold any stocks of pharmaceutical companies. He is honorary secretary of the German Migraine and Headache Society. S.E. has received honoraria for consulting and lectures within the past three years from Allergan, Lilly, Lundbeck, Novartis, and Teva. D.T.: research support/principal investigator (clinical trials): AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Dermira, Eli Lilly, Galderma, GSK, Janssen-Cilag, Leo-Pharma, Novartis, Pfizer, Regeneron, Roche, Sandoz-Hexal, Sanofi, and UCB; consultant: AbbVie, Almirall, Amgen, Dignity, Galapagos, Leo Pharma, Maruho, Mitsubishi, Novartis, Sanofi, Pfizer, Regeneron, Target-Solution, and UCB; lectures: AbbVie, Almirall, Amgen, Janssen, Leo Pharma, MSD, Novartis, Pfizer, Roche-Posay, Sandoz-Hexal, Sanofi, and UCB; scientific advisory board: AbbVie, Boehringer Ingelheim, Eli Lilly, Galapagos, Janssen-Cilag, Leo Pharma, Morphosis, Novartis, Pfizer, Regeneron, Sanofi, and UCB. All other authors declare that they have no competing interests.

Figures

Figure 1
Figure 1
Study design. Patients used the DTx sinCephalea over the course of 16 weeks. The baseline phase was set to be the first four weeks in which patient’s glucose reaction were recorded with a continuous glucose monitoring device (CGM) and the personalized dietary recommendations were determined. Disease severity was assessed with a headache diary and validated migraines questionnaires on impairment in daily life (Headache Impact Test 6-items [HIT-6] and Migraine Disability Score [MIDAS]), and quality of life (EQ-5D-5L). This was followed by a twelve-week intervention phase, in which dietary recommendations were implemented. In the last four-weeks of intervention phase, the disease severity was assessed again for an intra-individual pre-post comparison.
Figure 2
Figure 2
Continuous Glucose Monitoring (CGM) data of migraine patients and healthy patients. A comparison of CGM data of 49 migraine patients with those of 103 healthy individuals matched for BMI, age, and weight showed that migraine patients spent significantly more time in a glucose range between 80–130 mg/dL and less in the range < 80 mg/dL.
Figure 3
Figure 3
Flow chart of patients included in the second study. 97 patients activated the access code to the DTx sinCephalea. 71 patients were included in the analysis as they fulfilled the criteria of completed headache diary on at least 22 days and reported migraine headache on at least three days in the baseline phase. 62 patients also provided information on at least 22 days of the last four weeks of the intervention phase and were included in the completed data set analysis. Missing data of the last four weeks of the intervention phase from the remaining nine patients was analyzed using imputation with baseline-observation-carried-forward (intention-to-treat analysis).
Figure 4
Figure 4
Change in the number of monthly migraine headache days between the four-week baseline phase and the last four weeks of the intervention phase in the complete data set analysis (n = 62). Number of headache days was assessed by daily headache diary. Boxplots show 1st quartile, median (solid line), mean (dashed line), and 3rd quartile. Outliers are marked with dots.
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