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

August 5, 2021 updated by: Kinderkrankenhaus auf der Bult

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

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).

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30173
        • Kinder- und Jugendkrankenhaus AUF DER BULT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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 Names:
  • Senseonics Continuous Glucose Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time in range
Time Frame: 90 days
Reduction of time in range of Glucose < 70-mg/dL when using the Senseonics CGM System
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
three weeks of the blinded phase compared to the last three weeks before 90 days visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Thomas Danne, MD, Kinder- und Jugendkrankenhaus AUF DER BULT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2018

Primary Completion (Actual)

September 11, 2019

Study Completion (Actual)

September 11, 2019

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 21, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IIT-FNH-01

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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