An Investigator Initiated Pilot Study to Evaluate the Impact on Glucose Control and Safety of the Eversense Continuous Glucose Monitoring System in Children and Adolescents
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Self Care
- Sponsor
- Kinderkrankenhaus auf der Bult
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- time in range
- Status
- Completed
- Last Updated
- last year
Overview
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 (CGM) measurements when compared with finger stick blood glucose monitoring in an outpatient setting. (The investigation will also evaluate safety of the Senseonics CGM System usage, get feedback regarding subject and caregiver acceptability of the device and the mobile medical application (MMA).
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 diabetes mellitus for up to 180 days. Study will evaluate the system at home with comparison to SMBG with clinic check visits and downloading of stored data every 30 days. Subjects will have one Sensor inserted subcutaneous by trained Investigators. The System will be set to provide real-time glucose information, including alarms and alerts in the home settings. The system is for adjunctive use. All diabetes care decisions will be based on SMBG values rather than System CGM results.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
- •Mental incapacity or psychiatric disorders (Major Depression, anxiety disorders, schizophrenia)
- •Language barriers
Outcomes
Primary Outcomes
time in range
Time Frame: 90 days
Reduction of time in range of Glucose \< 70-mg/dL when using the Senseonics CGM System
Secondary Outcomes
- time of hypoglycemia(three weeks of the blinded phase compared to the last three weeks before 90 days visit)