E14
Conditions
Interventions
Group 1: In this post-market clinical investigation, the performance of the CareSens Air continuous glucose monitoring system (CGM system) will be examined in the hypo- and hyperglycemic glucose level
Sponsors
i-SENS, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of type 1 diabetes mellitus - Intensive insulin therapy established for at least six months - An understanding of and willingness to follow the protocol - Signed informed consent
Exclusion criteria
Exclusion criteria: - Participation in the previous pivotal performance study conducted at the IfDT (DRKS00028739, protocol number IfDT-1936-IE) - Hypoglycemia unawareness - Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment - HbA1c > 10% - Severe diabetes-relevant complications (i.e., severe macro- and/or microangiopathy, severe neuro-, retino- or nephropathy) - Body mass index (BMI) <20 kg/m² - Severe acute or severe chronic illness (at the physician’s discretion) - Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immuno-deficiency virus (HIV) or other chronic infectious disease - Intake of anticoagulants, except of platelet aggregation inhibitors - Planned medical procedures during the clinical investigation that could affect the performance of the investigational CGM systems, including magnetic resonance imaging, computer tomography scan, radiofrequency ablation, high-frequency electrical heat or high-intensity focused ultrasound - Unwilling to avoid thermal bathing, sauna, excessive exercises and contact sports for the duration of the core study period - Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives - Skin alteration at the insertion sites (e.g. severe psoriasis vulgaris, severe scaring, severe lipodystrophia, severe rash) - Female participants: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy) - Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the clinical investigation procedures, e.g., mental or visual incapacity, language barriers, alcohol or drug misuse - Employee (or their life partner or children) of the sponsor or the clinical investigation site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of this clinical investigation are the percentage of CGM-comparator pairs with comparator measurement 300 mg/dl. Here only venous comparator measurements with YSI will be considered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of this clinical investigation are a subset of the proposed eCGM accuracy requirements: - For comparator measurements 180 mg/dl, - For comparator measurements >180 mg/dl, the percentage of CGM-comparator pairs with difference within ±15% or ±40% (relative to the comparator value), as well as with CGM values <70 mg/dl. These analyses will be carried out for both YSI and Integra comparator measurements. | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Outcome results
None listed