A prospective, monocenter, single-arm, open-label, interventional, post-market follow-up evaluation of the CareSens Air continuous glucose monitoring system in adult patients with type 1 and type 2 diabetes
- Conditions
- E14Unspecified diabetes mellitus
- Registration Number
- DRKS00034614
- Lead Sponsor
- i-SENS, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
•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
•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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method %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 Outcome Measures
Name Time Method •Analytical point accuracy (overall, as well as stratified by glucose concentration or glucose rate of change)<br>•Clinical point accuracy in terms of consensus error grid analysis<br>•Trend accuracy in terms of concurrence between comparator and CareSens Air rates of change<br>•Stability in terms of %20/20 agreement stratified by day of in-house session<br>•Alert reliability<br>•Technical reliability<br>•Comparison of the two different CGM systems’ (CareSens Air vs. FreeStyle Libre 3) accuracy, each vs. comparator measurement results (capillary values)<br>•User experience of the two CGM systems (assessment by questionnaire)