E14
Conditions
Interventions
Group 1: To obtain comparative data, the subjects wear three CareSens Air devices simultaneously for the duration of the study (15 x 24 hours over 16 days) as well as a FreeStyle Libre 3 system as com
Sponsors
i-SENS, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Clinical diagnosis of type 1 or type 2 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: • Hypoglycemia unawareness • Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment • HbA1c > 10% • 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 lipodystrophy, severe rash, large tattoos hindering insertion at unchanged skin regions) • Severe diabetes-relevant complications (i.e., severe macro- and/or microangiopathy, severe neuro-, retino- or nephropathy) • Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g., seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis • Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental or visual incapacity, language barriers, alcohol or drug misuse • Unwilling to abstain from use of nutritional supplements containing xylose • Intake of anticoagulants, except of platelet aggregation inhibitors • Unwilling to avoid thermal bathing, sauna, excessive exercises and contact sports for the duration of the core study period • Planned medical procedures during the core study period that could affect the performance of the CGM systems, including magnetic resonance imaging, computer tomography scan, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound • Wearing a cardiac pace maker or other comparable medical devices • Dependency from the sponsor or the clinical investigator • Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immuno-deficiency virus (HIV) or other chronic infectious disease • Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| %20/20 agreement rate, defined as the percentage of valid pairs of CGM values and corresponding capillary comparator values with difference less than ±20% or ±20 mg/dl at comparator glucose concentrations >100 or =100 mg/dl. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Analytical point accuracy (overall, as well as stratified by glucose concentration or glucose rate of change) • Clinical point accuracy in terms of consensus error grid analysis • Trend accuracy in terms of concurrence between comparator and CareSens Air rates of change • Stability in terms of %20/20 agreement stratified by day of in-house session • Alert reliability • Technical reliability • Comparison of the two different CGM systems’ (CareSens Air vs. FreeStyle Libre 3) accuracy, each vs. comparator measurement results (capillary values) • User experience of the two CGM systems (assessment by questionnaire) | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed