Type 1 and Type 2 Diabetes Mellitus
Conditions
Interventions
Group 1: To obtain comparative data, participants will wear two Accu-Chek SmartGuide systems on their left and right upper arms for the duration of the study (14 x 24 hours over 15 calendar days). One
Sponsors
Roche Diabetes Care GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diabetes mellitus type 1 or type 2
Exclusion criteria
Exclusion criteria: 1. Serious acute and chronic illness that, in the investigator's opinion, could pose a risk to the subject during study participation 2. Known severe adhesive incompatibility (including allergic contact dermatitis) or allergies 3. Skin alteration at the application sites (e.g., severe psoriasis vulgaris, extensive scarring, severe lipodystrophy, severe rash, tattoos) 4. HbA1c >9.5% / 80.3 mmol/mol 5. Hematocrit greater than 10% below the lower limit of normal 6. Body mass index (BMI) <20 kg/m² 7. Female subjects: pregnancy, breastfeeding, lack of a negative pregnancy test (except in the case of menopause, sterilization, or hysterectomy) 8. Any incapacity or condition that, in the investigator's opinion, impairs reasonable compliance with the study procedures, e.g., B. mental or visual impairment, language barriers, alcohol or drug abuse 9. Impaired mobility that prevents subject from sensor application as per IFU 10. Intake of ascorbic acid (=500 mg daily dose); Methyldopa or gentisic acid within a period equal to three times the half-life of the respective drug before application of the investigational device or the planned administration, or during the clinical trial 11. Use of anticoagulants or antiplatelet agents (except acetylsalicylic acid, daily dose <300 mg), phenprocoumon (e.g., warfarin), NOACs (e.g., dabigatran, rivaroxaban) within two weeks prior to administration of the investigational product or during the study 12. MRI, CT, radiofrequency ablation, high-frequency electrical thermal therapy, or high-intensity focused ultrasound planned during the study 13. Employee or direct family member of an employee of the sponsor, the study site, or companies operating in the CGM field, or their subsidiaries 14. Participation in another clinical trial during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to show if applying an additional overtape increases the proportion of the Accu-Chek SmartGuide systems that remain functional for the entire 14-day intended wear period under real-world use. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate the performance and ease of use of the overtaped investigational device compared to the uncovered investigational device. | — |
Countries
Austria, Germany
Contacts
Public ContactThomas Forst
CRS Clinical Research Services Mannheim GmbH
Outcome results
None listed