Status:
COMPLETED
Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth
Lead Sponsor:
Kinderkrankenhaus auf der Bult
Collaborating Sponsors:
Senseonics, Inc.
Conditions:
Self Care
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
The purpose of this clinical investigation is to provide pilot clinical data to direct pivotal study development for the pediatric indication of the Senseonics Continuous Glucose Monitoring System (CG...
Detailed Description
This is a non-randomized, non-blinded, prospective, single-arm, single-center pilot study, enrolling up to 15 pediatric subjects in two cohorts (5 subjects age 6-12 and 10 subjects age 13-17) with dia...
Eligibility Criteria
Inclusion
- Pediatric subjects ≥6 and \< 18 years with Type 1 Diabetes
- HbA1c \< 11 % at Screening
- Subject/legal guardian has signed an informed consent form before any study related activities and is willing to comply with protocol requirements
- Clinically confirmed diagnosis of diabetes mellitus for ≥ 1 year
- Pretreated with CSII or ICT with a minimum duration of 3 month
- Patient and parents are physically and mental able to exercise as determined the "Eversense" System
- Patient must be willing to document every diabetes relevant information (meals, carbs, physical activity, extraordinary stress,…)
- Patient is willing to follow protocol and procedures for study
- Patient has the possibility to use a smartphone which is compatible with the system in daily life
Exclusion
- Patients are unwilling to follow the study procedures
- Patient is absent for a longer time (no possibility for visits)
- Patient is unable to tolerate tape adhesive in the area of sensor placement
- Patient has any unresolved adverse skin condition in the area of sensor placement (e.g. atopic dermatitis, psoriasis, rash,…)
- Patient is allergic to components of sensor material (Polymethylmethacrylate, dexamethasone, local anesthesia)
- Eating disorder: e.g. bulimia, anorexia
- Infections with hepatitis B, C or HIV
- Coagulation disorder, wound healing disorder
- Pregnancy
- Mental incapacity or psychiatric disorders (Major Depression, anxiety disorders, schizophrenia)
- Language barriers
- Medication which is influencing metabolic control as systemic steroids, other non-Routine hormones
- Medication influencing coagulation as Marcumar or systemic Xa-Antagonists as well as known bleeding disorders
- People known to M. Addison
- Untreated coeliac disease (Transglutaminase at screening elevated 2x\>upper limit)
- Severe diseases as cancer, heart failure, M. Parkinson, diabetic nephropathy or neuropathy or cardiomyopathy
- Severe hypoglycemia in the past 3 months (defined as seizure or loss of consciousness)
- Alcohol or drug abuse other than nicotine
- Precluding adequate understanding or cooperation
- A condition requiring or likely to require magnetic resonance imaging (MRI) during the study duration.
- Any condition that in the investigator's opinion would make the subject unable to complete the study
- Participation in another clinical investigation within 30 days or intent to participate during the study period
- Patients with Diabetes mellitus Type 2.
Key Trial Info
Start Date :
October 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03815552
Start Date
October 8 2018
End Date
September 11 2019
Last Update
October 15 2024
Active Locations (1)
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1
Kinder- und Jugendkrankenhaus AUF DER BULT
Hanover, Lower Saxony, Germany, 30173