E11
Conditions
Interventions
Group 1: To obtain comparative data, the subjects wear one test device on their upper arm for the duration of the study (14 x 24 hours over 15 days). On 3 days during this period, frequent BG measurem
Sponsors
Roche Diabetes Care GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of type 2 diabetes mellitus - HbA1c =10%
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of type 1 diabetes mellitus, gestational diabetes mellitus, latent autoimmune diabetes in adults or maturity-onset diabetes of the young 2. Treatment with intensified insulin therapy 3. Severe acute or severe chronic illness that might pose additional risk to the subject during the course of the study (at the physician’s discretion) 4. Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives 5. Skin alteration at the insertion sites (e.g. severe psoriasis vulgaris, severe scarring, severe lipodystrophia, severe rash) 6. Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy) 7. Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental or visual incapacity, language barriers, alcohol or drug misuse 8. Intake of ascorbic acid (=500mg total daily dose); methyldopa or gentisic acid within one week prior to application of the investigational devices and during the course of the clinical study 9. Anticoagulant treatment and platelet inhibition (with the exception of acetyl salicylic acid, total daily dose rate <300 mg), Phenprocoumon (e.g. Marcumar), NOAC (e.g. Dabigatran, Rivaroxaban) within 2 weeks prior to planned application of the investigational devices and during the course of the clinical study 10. C peptide levels <0.5 µg/l 11. Planned MRT, CT, X-ray, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound planned during the course of the study 12. Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immuno-deficiency virus (HIV) or other chronic infectious disease 13. Employee or immediate family member of an employee of the sponsor or the clinical investigation site 14. Participation in another clinical investigation at the time of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the clinical investigation is to evaluate the performance of the Accu-Chek SmartGuide device in people with type 2 diabetes. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate usability of the Accu-Chek SmartGuide device and the Accu-Chek SmartGuide App by people with type 2 diabetes. | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Outcome results
None listed