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

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ClinicalTrials.gov Identifier: NCT03815552
Recruitment Status : Completed
First Posted : January 24, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
Senseonics, Inc.
Information provided by (Responsible Party):
Kinderkrankenhaus auf der Bult

Study Description
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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).

Condition or disease Intervention/treatment Phase
Self Care Device: Eversense Continuous Glucose Monitoring Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 8, 2018
Actual Primary Completion Date : September 11, 2019
Actual Study Completion Date : September 11, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: Eversense Continuous Glucose Monitoring
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
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.
Other Name: Senseonics Continuous Glucose Monitoring System


Outcome Measures
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Primary Outcome Measures :
  1. time in range [ Time Frame: 90 days ]
    Reduction of time in range of Glucose < 70-mg/dL when using the Senseonics CGM System


Secondary Outcome Measures :
  1. time of hypoglycemia [ Time Frame: three weeks of the blinded phase compared to the last three weeks before 90 days visit ]
    Percentage time of hypoglycemia (Glucose <70 mg/dL


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pediatric subjects ≥6 and < 18 years with Type 1 Diabetes
  2. HbA1c < 11 % at Screening
  3. Subject/legal guardian has signed an informed consent form before any study related activities and is willing to comply with protocol requirements
  4. Clinically confirmed diagnosis of diabetes mellitus for ≥ 1 year
  5. Pretreated with CSII or ICT with a minimum duration of 3 month
  6. Patient and parents are physically and mental able to exercise as determined the "Eversense" System
  7. Patient must be willing to document every diabetes relevant information (meals, carbs, physical activity, extraordinary stress,…)
  8. Patient is willing to follow protocol and procedures for study
  9. Patient has the possibility to use a smartphone which is compatible with the system in daily life

Exclusion Criteria:

  1. Patients are unwilling to follow the study procedures
  2. Patient is absent for a longer time (no possibility for visits)
  3. Patient is unable to tolerate tape adhesive in the area of sensor placement
  4. Patient has any unresolved adverse skin condition in the area of sensor placement (e.g. atopic dermatitis, psoriasis, rash,…)
  5. Patient is allergic to components of sensor material (Polymethylmethacrylate, dexamethasone, local anesthesia)
  6. Eating disorder: e.g. bulimia, anorexia
  7. Infections with hepatitis B, C or HIV
  8. Coagulation disorder, wound healing disorder
  9. Pregnancy
  10. Mental incapacity or psychiatric disorders (Major Depression, anxiety disorders, schizophrenia)
  11. Language barriers
  12. Medication which is influencing metabolic control as systemic steroids, other non-Routine hormones
  13. Medication influencing coagulation as Marcumar or systemic Xa-Antagonists as well as known bleeding disorders
  14. People known to M. Addison
  15. Untreated coeliac disease (Transglutaminase at screening elevated 2x>upper limit)
  16. Severe diseases as cancer, heart failure, M. Parkinson, diabetic nephropathy or neuropathy or cardiomyopathy
  17. Severe hypoglycemia in the past 3 months (defined as seizure or loss of consciousness)
  18. Alcohol or drug abuse other than nicotine
  19. Precluding adequate understanding or cooperation
  20. A condition requiring or likely to require magnetic resonance imaging (MRI) during the study duration.
  21. Any condition that in the investigator's opinion would make the subject unable to complete the study
  22. Participation in another clinical investigation within 30 days or intent to participate during the study period
  23. Patients with Diabetes mellitus Type 2.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815552


Locations
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Germany
Kinder- und Jugendkrankenhaus AUF DER BULT
Hannover, Lower Saxony, Germany, 30173
Sponsors and Collaborators
Kinderkrankenhaus auf der Bult
Senseonics, Inc.
Investigators
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Study Chair: Thomas Danne, MD Kinder- und Jugendkrankenhaus AUF DER BULT
More Information
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Responsible Party: Kinderkrankenhaus auf der Bult
ClinicalTrials.gov Identifier: NCT03815552    
Other Study ID Numbers: IIT-FNH-01
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kinderkrankenhaus auf der Bult:
type 1 diabetes
pediatrics
blood sugar devices