Diabetes mellitus type 1 and type 2
Conditions
Interventions
Group 1: All subjects will wear up to two sensors simultaneously on the back of each upper arm for up to 14 days (14 x 24 hours) and will participate in both study visits at the investigational site a
Sponsors
Roche Diabetes Care GmBH
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Diabetes mellitus diagnosed at least 3 months prior to screening Subject agrees to participate in the study by giving informed consent/assent (as applicable) Signed and dated informed consent form of guardians/caregivers and willingness to participate and comply with clinical study procedures
Exclusion criteria
Exclusion criteria: Serious acute or chronic disease besides diabetes mellitus that per investigator may pose a risk to the subject Severe hypoglycemia which required the help of another person or resulting in seizure or loss of consciousness in the 3 months prior to enrollment Diabetic ketoacidosis in the 3 months prior to enrollment HbA1c =12%. Severe diabetes relevant complications Significantly impaired awareness of hypoglycemia Known strong adhesive incompatibility and/or other contact allergies Skin alterations and/or tattoos at the sensor application sites Intake of ascorbic acid (=500 mg 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. Diagnosed with any chronic medical, psychiatric, developmental/behavioral condition that, at the discretion of the investigator, would affect their performance or safety in the study Subjects scheduled for unchangeable X-ray, magnetic resonance imaging (MRI) or computerized tomography (CT) during the study Female subjects with sexual maturity: pregnancy, lactation period, lack of a negative pregnancy test Guardians/caregivers: Dependency from the sponsor, competitors in the field of CGM or the clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the 20/20 agreement rate of paired capillary blood glucose values based on self-monitoring of blood glucose measurements during on-site visits with frequent sampling periods | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary endpoints, accuracy, precision, stability, and performance are evaluated based on the CGM system's measurements across different rates of glucose change and across various glucose ranges. Additionally, bleeding at sensor insertion will be classified and user satisfaction will be assessed using a questionnaire. | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Ulm GmbH
Outcome results
None listed