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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 21, 2019
First Posted Date  ICMJE January 24, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE October 8, 2018
Actual Primary Completion Date September 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
time in range [ Time Frame: 90 days ]
Reduction of time in range of Glucose < 70-mg/dL when using the Senseonics CGM System
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Self Care
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: Eversense Continuous Glucose Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 11, 2019
Actual Primary Completion Date September 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03815552
Other Study ID Numbers  ICMJE IIT-FNH-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kinderkrankenhaus auf der Bult
Study Sponsor  ICMJE Kinderkrankenhaus auf der Bult
Collaborators  ICMJE Senseonics, Inc.
Investigators  ICMJE
Study Chair: Thomas Danne, MD Kinder- und Jugendkrankenhaus AUF DER BULT
PRS Account Kinderkrankenhaus auf der Bult
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP