A prospective, monocenter, single-arm, open-label study to collect data for algorithm optimization of the Continuous Glucose Monitoring System CareSens Neon in adult patients with type 1 diabetes
- Conditions
- E14Unspecified diabetes mellitus
- Registration Number
- DRKS00032140
- Lead Sponsor
- i-SENS, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 23
Patients with type 1 diabetes who have been using intensive insulin therapy for at least 3 months
- Patients who voluntarily decided to participate in the study and provide written informed consent
1. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
2. Hypoglycemia unawareness
3. Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy)
4. Known severe tape reactions or allergies
5. Skin alteration at the insertion sites (i.e. Psoriasis vulgaris, scars, lipodystrophia)
6. MRT, CT, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound needed during the course of the study.
7. Patients unwilling to abstain from use of nutritional supplements containing xylose
8. 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
9. 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
10. Dependency from the sponsor or the clinical investigator
11. HbA1c > 10%
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Collecting data with the CareSens Neon CGM-system for algorithm optimization.
- Secondary Outcome Measures
Name Time Method Various performance and accuracy parameters will be compared between CareSens Neon and FreeStyle Libre 3.<br>User friendliness of CareSens Neon (assessment by questionnaire)<br>