A Digital Therapeutic Allowing a Personalized Low-Glycemic Nutrition for the Prophylaxis of Migraine: Real World Data from Two Prospective Studies
Abstract
:1. Introduction
2. Materials and Methods
2.1. SinCephalea
2.2. Study Design: Real World Data Analyses
2.3. Assessment Tools
2.4. Study Population
2.5. Glucose Data Analysis
2.6. Statistical Analysis
2.7. Adverse Events
3. Results
3.1. First Study Collecting Real World Data from Patients Using sinCephealea as Migraine Prophylaxis
3.1.1. Baseline Demographics of First Study Population
3.1.2. Baseline Disease Severity
3.1.3. Comparison of Disease Severity between Baseline and End of the Intervention Phase
3.1.4. Continuous Glucose Measurement
3.2. Recapitulation in a Second Study Collecting Real World Data from Patients Using sinCephealea DTx as Migraine Prophylaxis
3.2.1. Patient Flow
3.2.2. Baseline Demographics of Second Study Population
3.2.3. Baseline Disease Severity
3.2.4. Reduction of Migraine Headache from Baseline to Intervention
3.2.5. Migraine Questionnaires
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variable | Time | Mean (SD) | Median | Min | Max | Change [95% CI] | p-Value |
---|---|---|---|---|---|---|---|
Headache days (per four weeks) | Baseline | 4.26 (3.36) | 3.0 | 1.0 | 21.0 | −2.43 [−3.36; −1.49] −62.55% [−78.32; −46.78] | <0.001 |
Intervention | 1.83 (3.50) | 0.0 | 0.0 | 18.0 | |||
Average intensity of headache (0–10) | Baseline | 6.29 (1.37) | 6.0 | 4.0 | 9.0 | −0.68 [−1.24; −0.12] | <0.05 |
Intervention | 5.53 (1.50) | 6.0 | 3.0 | 8.0 | |||
HIT-6 (Score 36–78) | Baseline | 61.80 (4.60) | 62.0 | 44.0 | 72.0 | −4.48 [−6.82; −2.60] | <0.001 |
Intervention | 57.50 (5.62) | 58.0 | 44.0 | 67.0 | |||
MIDAS | Baseline | 37.6 (58.9) | 25.0 | 0.0 | 370.0 | −11.03 [−21.87; −0.44] −45.5% [−44.66; 5.39] | <0.01 |
Intervention | 20.3 (20.4) | 15.0 | 0.0 | 81.0 | |||
EQ-5D-5L (index value) | Baseline | 0.891 (0.11) | 0.909 | 0.505 | 1.000 | +4.50 [−0.06; 7.89]) | <0.05 |
Intervention | 0.942 (0.08) | 0.999 | 0.719 | 1.000 |
Variable | Time | Mean (SD) | Median | Min | Max | Change [95% CI] | p-Value |
---|---|---|---|---|---|---|---|
Complete Data Set (n = 62) | |||||||
Migraine headache days | Baseline | 7.59 (3.91) | 6.15 | 3.00 | 16.59 | −2.40 [−3.37; −1.42] | <0.001 |
Intervention | 5.20 (3.61) | 5.00 | 0.00 | 14.00 | |||
Non-migraine headache days | Baseline | 2.54 (3.04) | 2.04 | 0.00 | 18.31 | −1.26 [−1.79; −0.72] | <0.001 |
Intervention | 1.28 (2.69) | 0.00 | 0.00 | 18.26 | |||
Cumulative duration of migraine headache | Baseline | 61.21 (39.31) | 58.99 | 8.05 | 182.03 | −15.22 [−25.54; −4.90] | 0.005 |
Intervention | 45.99 (39.52) | 35.54 | 0.00 | 171.21 | |||
Intention-to-Treat (n = 71) | |||||||
Migraine headache days | Baseline | 7.78 (3.92) | 6.46 | 3.00 | 16.59 | −2.23 [−3.10; −1.37] | <0.001 |
Intervention | 5.55 (3.83) | 5.00 | 0.00 | 15.17 | |||
Non-migraine headache days | Baseline | 2.55 (2.98) | 2.00 | 0.00 | 18.31 | −1.14 [−1.62; −0.66] | <0.001 |
Intervention | 1.40 (2.69) | 1.00 | 0.00 | 18.26 | |||
Cumulative duration of migraine headache | Baseline | 62.79 (38.28) | 59.50 | 8.05 | 182.03 | −14.20 [−23.30; −5.11] | 0.001 |
Intervention | 48.58 (39.45) | 36.78 | 0.00 | 171.21 |
Variable | Time | Mean (SD) | Median | Min | Max | Change [95% CI] | p-Value |
---|---|---|---|---|---|---|---|
HIT-6 (Score 36–78) | Baseline | 64.43 (3.85) | 65.00 | 52.00 | 74.00 | −3.17 [−4.63; −1.70] | <0.001 |
Intervention | 61.27 (6.34) | 62.00 | 44.00 | 76.00 | |||
MIDAS | Baseline | 53.57 (48.28) | 41.50 | 2.00 | 279.00 | −13.45 [−22.01; −4.89] | 0.002 |
Intervention | 40.12 (45.25) | 27.50 | 0.00 | 259.00 | |||
EQ-5D-5L (index value) | Baseline | 0.87 (0.17) | 0.91 | 0.325 | 1.00 | 0.022 [−0.03; 0.08] | 0.240 |
Intervention | 0.89 (0.17) | 0.91 | 0.048 | 1.00 |
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Lelleck, V.V.; Schulz, F.; Witt, O.; Kühn, G.; Klein, D.; Gendolla, A.; Evers, S.; Gaul, C.; Thaçi, D.; Sina, C.; et al. A Digital Therapeutic Allowing a Personalized Low-Glycemic Nutrition for the Prophylaxis of Migraine: Real World Data from Two Prospective Studies. Nutrients 2022, 14, 2927. https://doi.org/10.3390/nu14142927
Lelleck VV, Schulz F, Witt O, Kühn G, Klein D, Gendolla A, Evers S, Gaul C, Thaçi D, Sina C, et al. A Digital Therapeutic Allowing a Personalized Low-Glycemic Nutrition for the Prophylaxis of Migraine: Real World Data from Two Prospective Studies. Nutrients. 2022; 14(14):2927. https://doi.org/10.3390/nu14142927
Chicago/Turabian StyleLelleck, Vivian Valeska, Franziska Schulz, Oliver Witt, Gianna Kühn, Dominik Klein, Astrid Gendolla, Stefan Evers, Charly Gaul, Diamant Thaçi, Christian Sina, and et al. 2022. "A Digital Therapeutic Allowing a Personalized Low-Glycemic Nutrition for the Prophylaxis of Migraine: Real World Data from Two Prospective Studies" Nutrients 14, no. 14: 2927. https://doi.org/10.3390/nu14142927