- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03815552
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
Intervention / Treatment
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
-
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Lower Saxony
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Hannover, Lower Saxony, Germany, 30173
- Kinder- und Jugendkrankenhaus AUF DER BULT
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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:
- 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
- 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)
- Severe diseases as cancer, heart failure, M. Parkinson, diabetic nephropathy or neuropathy or cardiomyopathy
- Severe hypoglycemia in the past 3 months (defined as seizure or loss of consciousness)
- Alcohol or drug abuse other than nicotine
- Precluding adequate understanding or cooperation
- A condition requiring or likely to require magnetic resonance imaging (MRI) during the study duration.
- Any condition that in the investigator's opinion would make the subject unable to complete the study
- Participation in another clinical investigation within 30 days or intent to participate during the study period
- 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.
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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:
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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.
Sponsor
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
Keywords
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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