Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial.

BACKGROUND: Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits. METHODS/DESIGN: This multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis. DISCUSSION: To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act. TRIAL REGISTRATION: German Clinical Trial Register DRKS00022923 . Registered on 22 October 2020.

[Plasma concentration and amnesia following lormetazepam and flunitrazepam in i.v. premedication]. / Plasmakonzentration und Amnesie nach Lormetazepam und Flunitrazepam bei i.v.-Prämedikation.

The correlation between serum levels and degree of amnesia following 0.03 mg/kg lormetazepam or 0.02 mg/kg flunitrazepam was analysed in a prospective randomised single-blind study evaluating 20 patients with ASA classification I in each group. Blood specimens were drawn and amnesia tests performed 20, 40 and 60 min. after drug administration. The plasma level of lormetazepam was 1.8 to 2.0 times higher than that of flunitrazepam; however, the difference of lormetazepam concentrations was considerably large between the investigated individuals. There was no difference in the degree of amnesia, but also no correlation with plasma levels was measured. A serum level breakpoint for the occurrence of amnesia could not be defined.