E14
Conditions
Interventions
Group 1: To compare the efficacy and safety of the devices subjects (persons with type 1 diabetes or type 2 diabetes) wear two systems for continuous
glucose monitoring in parallel. The experimental p
Sponsors
i-SENS, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with type 1 or type 2 diabetes who use intensive insulin therapy for at least 3 months - Patients who voluntarily decided to participate in the study and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Potential subjects older than = 45 years with more than 2 further cardiovascular risk factors (see factors a-c below) will be excluded from study entry: a.) Smoker b.) Arterial hypertension (>140 / 90 mmHg) c.) HbA1c > 9.0 % 2. Patients with the following abnormal skin or skin diseases or skin alterations at the CGM sensor attachment or insertion site Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash, Staphylococcus aureus infection, etc. 3. Patients with allergic contact dermatitis to medical adhesives 4. Patients with severe hypoglycemia events requiring emergency medical treatment within 6 months prior to screening 5. Patients with >1 episode of diabetic ketoacidosis within the past 6 months prior to screening 6. Patients with cerebrovascular diseases or cardiovascular diseases when instable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy, including, but not limited to: Ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease, serious arrhythmia, etc. 7. Patients with epilepsy, syncope, or adrenal disorders within 6 months prior to screening 8. Patients with chronic infectious disease 9. Patients with anemia (hemoglobin below normal range) 10. Patients scheduled for unchangeable X-ray, MRI, or CT during the study 11. Pregnant or lactating women or those who plan to become pregnant or do not agree to use an adequate method of contraception during the study 12. Patients who are currently participating or participated within 2 weeks prior to screening in another study or plan to participate in another study that in the opinion of the investigator would affect the safety of the study subject or the study result 13. Patients unwilling to abstain from use of nutritional supplements containing xylose 14. Patients with cognitive impairment or who are not suitable for this study or may be at increased risk associated with study participation in the opinion of the investigator 15. Wearing of a pace maker or other comparable medical devices 16. Dependency from the sponsor or the clinical investigator 17. Hypoglycemia unawareness 18. History of frequent catheter abscesses associated with pump therapy 19. HbA1c >9.5% 20. Severe diabetes-relevant complications (i.e. severe macroangiopathy, severe microangiopathy, severe neuro-, retino- or nephropathy) 21. Unable to understand, read and write German
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: %20/20 accuracy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. %15/15, %20/20, %30/30, %40/40, and >%40/40 accuracies 2. Concurrence of CGM and CM values 3. MARD (Mean absolute relative difference) 4. MRD (Mean relative difference) 5. MAD (Mean absolute difference) 6. MD (Mean difference) 7. % CGM values in Zone A and Zone B of Consensus Error Grid 8. PARD (Precision absolute relative difference) 9. Alert performance - Hypoglycemia alert rate - True alert rate, false alert rate - Hypoglycemia detection rate - Detection rate, missed detection rate - Hyperglycemia alert rate - True alert rate, false alert rate - Hyperglycemia detection rate - Detection rate, missed detection rate 10. CGM system calibration stability 11. CGM sensor stability 12. CGM sensor life 13. Lag time 14. CGM system satisfaction | — |
Countries
Germany
Contacts
Public ContactNina Jendrike
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed