Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth

NCT03815552 | Completed FDA Device

• 1 other identifier: IIT-FNH-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Self Care

Keywords

type 1 diabetes; pediatrics; blood sugar devices

Outcome Measures

Primary Outcomes (1)

• time in range

  Reduction of time in range of Glucose \< 70-mg/dL when using the Senseonics CGM System

  90 days

Secondary Outcomes (1)

• time of hypoglycemia

  three weeks of the blinded phase compared to the last three weeks before 90 days visit

Study Arms (1)

Eversense Continuous Glucose Monitoring

EXPERIMENTAL

The Eversense Continuous Glucose Monitoring System is a glucose monitoring device intended to continually measure interstitial fluid glucose levels in individuals with type 1 Diabetes.The System will be set to provide realtime glucose information, including alarms and alerts in the home settings für 180 days.

Device: Eversense Continuous Glucose Monitoring

Interventions

Eversense Continuous Glucose Monitoring DEVICE

The Eversense Continuous Glucose Monitoring System is a glucose monitoring device intended to continually measure interstitial fluid glucose levels in individuals with diabetes for the operating life of the sensor.The System comprises a sensor and a transmitter. The small sensor will be subcutaneously inserted in the arm.The transmitter reads glucose data from the subcutaneous sensor.

Also known as: Senseonics Continuous Glucose Monitoring System

Eversense Continuous Glucose Monitoring

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kinderkrankenhaus auf der Bult: lead
• Senseonics, Inc.: collaborator

Study Sites (1)

Kinder- und Jugendkrankenhaus AUF DER BULT

Hanover, Lower Saxony, 30173, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Thomas Danne, MD

  Kinder- und Jugendkrankenhaus AUF DER BULT

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 24, 2019
• Study Start: October 8, 2018
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

DE (1)