New Diabetic Treatment by Alleviation of Autonomic Nervous System Dysfunction Measured as Periosteal Pressure Sensitivity at Sternum Improves Empowerment, Treatment Satisfaction, and Self-Reported Health of People with Type 2 Diabetes: A Randomized Trial

Abstract

Sofie Korsgaard Hecquet,1,2,* Søren Ballegaard,1,* Ebbe Eldrup,1,3 Christian Stevns Hansen,1,2 Tine Willum Hansen,2,3 Gitte Sommer Harboe,1 Peter Rossing,2,3 Caroline Sophie Hjelm Pichat,1 Torquil Watt,1 Finn Gyntelberg,4 Nanna Ørsted,1 Jens Oscar Faber1,3 1Department of Medicine, Endocrine Unit, Herlev Gentofte University Hospital, Herlev, Denmark; 2Clinical and Translational Research, Complications Research, Steno Diabetes Center Copenhagen, Herlev, Denmark; 3Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; 4The National Research Center for the Working Environment, Copenhagen, Denmark*These authors contributed equally to this workCorrespondence: Sofie Korsgaard Hecquet, Clinical and Translational Research, Complications Research, Steno Diabetes Center Copenhagen, Borgmester Ib Juuls vej 83, Herlev, Copenhagen, 2730, Denmark, Tel [phone], Email [email protected]: Autonomic nervous system dysfunction (ANSD), for which presently no treatment exists, has a negative impact on prognosis in people with type 2 diabetes (T2D). Periosteal pressure sensitivity (PPS) on sternum may be a measure of autonomic nervous system dysfunction (ANSD). We tested if a non-pharmacological PPS-feedback-guided treatment program based on non-noxious sensory nerve stimulation, known to reduce PPS, changed empowerment, treatment satisfaction, and quality of life in people with T2D, compared to usual treatment.Patients and Methods: Analysis of secondary endpoints in a single center, two-armed, parallel-group, observer-blinded, randomized controlled trial of individuals with T2D. Participants were randomized to non-pharmacological intervention as an add-on to treatment as usual. Endpoints were evaluated by five validated questionnaires: Diabetes specific Empowerment (DES-SF), Diabetes Treatment Satisfaction (DTSQ), quality of life (QOL) (WHO-5), clinical stress signs (CSS), and self-reported health (SF-36). Sample size calculation was based on the primary endpoint HbA1c.Results: We included 144 participants, 71 allocated to active intervention and 73 to the control group. Active intervention compared to control revealed improved diabetes-specific empowerment (p = 0.004), DTSQ (p = 0.001), and SF-36 self-reported health (p=0.003) and tended to improve quality of life (WHO-5) (p = 0.056). The findings were clinically relevant with a Cohen’s effect size of 0.5 to 0.7.Conclusion: This non-pharmacological intervention, aiming to reduce PPS, and thus ANSD, improved diabetes-specific empowerment, treatment satisfaction, and self-reported health when compared to usual treatment. The proposed intervention may be a supplement to conventional treatment for T2D.Keywords: type 2 diabetes, empowerment, autonomic nervous system dysfunction, periosteal pressure sensitivity

Keywords

• type 2 diabetes
• empowerment
• autonomic nervous system dysfunction
• periosteal pressure sensitivity