E14
Conditions
Interventions
Group 1: Persons with type 1 diabetes or type 2 diabetes:
To compare the accuracy of the devices, subjects wear two systems for continuous glucose monitoring in parallel. The experimental phase (15 da
Sponsors
A Menarini Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of type 1 or type 2 diabetes for at least one year - Only for subjects with intensified insulin therapy (MDI or CSII): these subjects have to have used this therapy for at least 6 months - HbA1c <10% - Age 18-65 years - Male, female or X-gender - An understanding of and willingness to follow the protocol - Signed informed consent
Exclusion criteria
Exclusion criteria: - Potential subjects older than = 45 years with more than 2 further cardiovascular risk factors (see factors a-c below) will be excluded from study participation: a) Smoker b) Arterial hypertension (>140 / 90 mmHg) c) HbA1c > 9.0 % - Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment - Hypoglycemia unawareness - Urea, Creatinine, ALT more than three times the upper limit of normal range - Thrombocytopenia (<120 G/l) - Clinical relevant anemia or hematocrit below 34 % (female) or 40 % (male) - Infection with hepatitis B, C or HIV - Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy) - Known severe tape reactions or allergies - History of frequent catheter abscesses associated with pump therapy - BMI < 20 kg/m² - 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, active infection - Severe diabetes related complications (i.e. severe macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy) when instable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy - Intake of anticoagulant medication (with the exception of ASS 100) - Known coagulation disease with increased risk of bleeding - Clinical relevant arrhythmia - Skin alteration at the insertion sites (i.e. Psoriasis vulgaris, scars, lipodystrophy) - 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 - Incapacity for informed consent - Cognitive impairment - Not able to understand, write or read German - Dependency from the sponsor or the clinical investigator - Wearing a cardiac pacemaker or similar medical devices - MRT, CT, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound planned during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CGM measurement performance will be measured for each of the CGM systems and will be analyzed using the mean of the duplicate Self-Monitored Blood Glucose (SMBG) measurements as reference. MARD (mean absolute relative difference) of complete sensor experiments of the GlucoMen® Day CGM system versus blood glucose monitoring system based on up to 1 BG value per hour. | — |
Secondary
| Measure | Time frame |
|---|---|
| - PARD (precision absolute relative difference) between the GlucoMen® Day CGM systems in one subject - MARD versus blood glucose monitoring system (all data) - MARD versus venous reference samples - MARD during dynamic phases versus blood glucose monitoring system - MARD at BG < 70 mg/dl - MAD at BG < 70 mg/dl - MARD during home-use days and in-house sessions - Consensus error grid analysis for the GlucoMen® Day CGM system versus blood glucose monitoring system (all BG data) - System accuracy of the GlucoMen® Day blood glucose monitoring system versus laboratory analyzer - Evaluation of questionnaire - Determination of time lag - Documented trend indicators will be compared to the tissue glucose change within 15 - 30 minutes | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed