Philipps University Marburg Medical Center

This randomized controlled trial (RCT) with 250 patients suffering from type 2 diabetes mellitus (T2DM) aims to investigate the effectiveness of the self-guided digital therapeutic covivio. Inclusion criteria are: male, female or non-binary; age ≥ 18 years; confirmed diagnosis of T2DM; elevated levels of diabetes-specific emotional distress (Problem Areas in Diabetes [PAID]-20 score ≥ 33); consent to participate; sufficient German language skills. Exclusion criteria are: a diagnosis of type 1 diabetes mellitus (T1DM); current use of continuous glucose monitoring (CGM) as part of one's diabetes treatment; changes or planned changes in medication within 4 weeks before the baseline visit or in the subsequent 6 months; a bariatric operation within 4 weeks before the baseline visit or such an operation planned in the subsequent 6 months; changes or planned changes in psychotherapeutic treatment within 4 weeks before the baseline visit or in the subsequent 6 months. In addition, participants will be excluded from the study if they did not wear the CGM sensor for at least 6 of 7 days at baseline (before randomization), providing a minimum of 96 hours of glucose values including at least 24 hours overnight.
Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to covivio in addition to treatment as usual (TAU, n = 125), or to a control group, in which they will receive only TAU (n = 125).
Co-primary endpoints of this trial will be the between-groups difference in the PAID-20 total score in the intervention and control group at six months, adjusted for the PAID-20 baseline score as well as the glucose management indicator (estimated HbA1c) assessed using continuous glucose monitoring devices (for a period of 7 days) at six months, adjusted for the baseline score.
Secondary endpoints will be diabetes self-management skills, body mass index (BMI), and quality of life.

The focus of the study is on patients Parkinson's disease showing as well behavioral disorders that can be described as pathological and are summarized under the term impulse control disorder (ICD). Changes in behavior and also pathological disorders are a common side effect of treatment for Parkinson's disease. The goal of this academic study is to compare the effect of surgical (deep brain stimulation, DBS) treatment combined with a coordinated and adapted best medical treatment (BMT) to be compared with the effect of optimized best medical treatment (BMT) alone. The stimulation arm (DBS+BMT) as well as the medication arm (BMT only) will be monitored according to clinical routine. Participants will have to agree to be randomly assigned to either deep brain stimulation in combination with the best medical treatment (DBS group) or the best medical treatment alone (BMT group). Participants will have to come regularly according to clinical routine to the clinic and complete various questionaires and scales for the study.

Speech assessment is a substudy to the STIMPulseControl study (hereinafter referred to as the main study), where audio recordings of patients voices will be recorded as part of a speech analysis in the main study, for this optional ancillary study.