Real-Time Continuous Glucose Monitoring (RT-CGM) in Patients With Type 1 Diabetes at High Risk for Low Glucose Values Using Multiple Daily Injections (MDI) in Germany (HYPODE-STUDY)

Inclusion Criteria:

• Patients with type 1 diabetes for at least 12 months on multiple daily injections (MDI). MDI is defined as prandial insulin injections at each major meal (excludes pre-mixed insulin) with doses determined by SMBG and carbohydrate counting, and basal insulin injection(s)
• Age ≥ 18 years
• HbA1c ≤ 9.0 % performed within 4 months before begin of the study
• High risk for severe hypoglycemia (defined as a score of 4 or higher on the Hypoglycemia unawareness scale (HUS) or a history of at least one severe hypoglycemic event in the last 12 months (required third part assistance, not able to treat themselves))
• Willing to not use paracetamol or drugs containing it
• Signed and dated Informed Consent Form

Exclusion Criteria:

• Use of personal real-time-CGM 3 months prior to study entry and during the study (except study devices)
• Use of a flash-glucose monitoring system 3 months prior to study and during the study
• Alcoholism or drug abuse
• Unable to comply with the protocol at the investigators discretion, such as known psychiatric diagnosis, cognitive / physical decline
• Pregnancy or lactation period
• Severe known allergies, e.g. against plaster
• Mental incapacity or language barriers precluding adequate compliance with the study procedures
• Limited or no legal capacity or legal guardianship
• Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research center or their families)
• Participation in another study at the same time with a non-approved drug or a non-CE-labelled medical device.