Diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
Subjects will insert a CGM device in the upper arm for continuous measurement of glucose levels in the subcutaneous interstitial fluid. The CGM sensor will be paired with a mobile application for moni
Sponsors
Roche Diabetes Care GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus type 1 or type 2 diagnosed at least 12 months prior to screening 2. If applicable, acceptance to inject insulin or wearing an insulin pump infusion set minimum 7.5 centimetre (cm) away from the CGM sensor application site
Exclusion criteria
Exclusion criteria: 1. Serious acute or chronic concomitant disease or an anamnesis which might, in the opinion of the investigator, pose a risk to the participant 2. Severe diabetes related complications 3. Significantly impaired awareness of hypoglycemia 4. Severe hypoglycemia which required the help of another person or resulting in seizure or loss of consciousness in the three months prior to enrolment 5. Acute illness or abnormality interfering with clinical study procedures 6. HbA1c 9.5 % / 80.3 mmol/mol 7. Hematocrit greater than 10% below the lower limit of normal 8. History of adhesive incompatibility and/or other contact allergies 9. Skin alterations at the application sites (e.g., psoriasis vulgaris, scars, lipodystrophy) 10. Anticoagulant treatment and platelet inhibition (with the exception of acetylsalicylic acid, daily dose rate 500 mg total daily dose); methyldopa or supplements with gentisic acid within two days prior to CGM application and during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance of the CGM solution assessed as the overall mean absolute relative difference (MARD) based on paired capillary blood glucose values on multiple days up to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Performance of the CGM solution assessed as the MARD for different glucose levels/ranges and rate of changes based on paired capillary blood glucose values on multiple days up to Day 14 2. Performance of the CGM solution assessed as the MARD per CGM sensor batch based on paired capillary blood glucose values on multiple days up to Day 14 3. Performance of the CGM solution assessed as an agreement rate based on paired capillary blood glucose values expressed as percentage falling within ±20/20 and ±40/40 (mg/dL <100 mg/dL, % =100 mg/dL) on multiple days from Day 1 up to Day 14 4. Consensus error grid (CEG) assessed up to Day 14 5. Lag time of the CGM sensor assessed up to Day 14 6. Failure rate of CGM solution and sensor survival rate up to Day 14 7. Number of adverse events (AEs), serious AEs (SAEs) adverse device effects (ADEs)/serious ADEs (SADEs) reported in accordance with Regulation (EU) 2017/745 on medical devices up to Day 22 8. Usability of the CGM solution assessed using a questionnaire for the subjects on Day 15 | — |
Countries
Germany
Contacts
Public ContactKatrin Mueller
Outcome results
None listed