E14
Conditions
Interventions
Group 1: The subjects (persons with diabetes) wear three CGM systems (one Dexcom G7, one FreeStyle Libre 3 and one Medtronic Guardian 4 or Medtronic Simplera CGM system) in parallel. The experimental
Sponsors
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of type 1 or type 2 diabetes mellitus 2. Age = 18 years 3. Intensive insulin therapy established for at least six months 4. An understanding of and willingness to follow the protocol 5. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. HbA1c > 10% 2. Hypoglycemia unawareness 3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment 4. Severe acute or severe chronic illness (at the physician’s discretion) 5. Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives 6. Skin alteration at the insertion sites (e.g., severe psoriasis vulgaris, severe scaring, severe lipodystrophia, severe rash) 7. Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy) 8. 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 9. Dependency from the sponsor or the clinical investigator 10. Intake of substances known to affect the performance of the investigational CGM systems, i.e., hydroxyurea, acetaminophen, and nutritional supplementation of ascorbic acid (vitamin C) 11. Planned medical procedures during the core study period 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 12. Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immuno-deficiency virus (HIV) or other chronic infectious disease 13. Body mass index (BMI) <20 kg/m² 14. Intake of anticoagulants, except for acetylsalicylic acid in doses up to 100 mg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characteristics of comparator data In order to ensure the validity of the performance analysis, the comparator data should have suitable characteristics. In particular, it is examined whether comparator BG levels and associated rate of change (RoC) comply with the following distribution: - =7.5% with BG300 mg/dL and any RoC - =7.5% with BG=70 mg/dL, RoC+1.5 mg/dL/min and BG>250 mg/dL within 30 min at current RoC - Measurement quality of comparator values - The bias of comparator data collected with the laboratory analyzer (LBD) and the blood glucose monitoring system (CNXT) should be <2.4% with respect to methods of higher metrological order. The imprecision of LBD and CNXT in terms of the coefficient of variation (CV) will be assessed based on duplicate measurements and should be <2.5%. This study has three primary performance endpoints: the %20 agreement rate of the FL3, DG7 and MG4/MSP with respect to venous comparator measurements. The %20 agreement rate is defined as the percentage of CGM-comparator pairs with relative difference =±20%, with respect to comparator values. | — |
Secondary
| Measure | Time frame |
|---|---|
| For each CGM system, %20 agreement rate with respect to - Venous comparator data collected during in-clinic sessions 1 and 2 (study days 2 and 5) - Capillary comparator data collected during all in-clinic sessions (study days 2, 5 and 15) - Capillary comparator data collected during in-clinic sessions 1 and 2 (study days 2 and 5) - Capillary comparator data collected within the first 12 hours of sensor insertion on study day 1 and according to the seven-point profile on study days 2-15. For each CGM system - Analytical point accuracy in terms of agreement and deviations (e.g., MARD) for different glucose ranges, as well as Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA) with respect to venous comparator data - Clinical point accuracy using consensus error grid analysis with respect to venous comparator data - Sensor stability in terms of agreement and deviations (e.g., MARD) stratified by study day with respect to capillary and venous comparator data - Trend accuracy in terms of agreement between CGM and venous comparator RoCs - Agreement outside the CGM measurement range with respect to venous comparator data - Alert reliability in terms of hypo- and hyperglycemia alert and detection rates with respect to venous comparator data - Technical reliability in terms of sensor survival, data availability and device deficiencies - User satisfaction as determined by a subject questionnaire - Differences in glycemic control metrics (Time in range, Time below range, etc.) between CGM systems within the same subject | — |
Countries
Germany
Contacts
Public ContactGuido Freckmann
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed