A prospective, single arm, open-label, interventional, pivotal study to evaluate the efficacy and safety of the Continuous Glucose Monitoring System ‘CareSens Air’ in adult patients with type 1 and type 2 diabetes
- Conditions
- E14Unspecified diabetes mellitus
- Registration Number
- DRKS00028739
- Lead Sponsor
- i-SENS, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint: %20/20 accuracy
- Secondary Outcome Measures
Name Time Method 1. %15/15, %20/20, %30/30, %40/40, and >%40/40 accuracies<br>2. Concurrence of CGM and CM values<br>3. MARD (Mean absolute relative difference)<br>4. MRD (Mean relative difference)<br>5. MAD (Mean absolute difference)<br>6. MD (Mean difference)<br>7. % CGM values in Zone A and Zone B of Consensus Error Grid<br>8. PARD (Precision absolute relative difference)<br>9. Alert performance <br>- Hypoglycemia alert rate<br>- True alert rate, false alert rate<br>- Hypoglycemia detection rate<br>- Detection rate, missed detection rate<br>- Hyperglycemia alert rate<br>- True alert rate, false alert rate<br>- Hyperglycemia detection rate<br>- Detection rate, missed detection rate<br>10. CGM system calibration stability<br>11. CGM sensor stability <br>12. CGM sensor life<br>13. Lag time<br>14. CGM system satisfaction<br>