Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth (FNH)
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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
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Condition or disease | Intervention/treatment | Phase |
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Self Care | Device: Eversense Continuous Glucose Monitoring | Not Applicable |
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 |

Arm | Intervention/treatment |
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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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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 |
- time in range [ Time Frame: 90 days ]Reduction of time in range of Glucose < 70-mg/dL when using the Senseonics CGM System
- 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

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

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
Germany | |
Kinder- und Jugendkrankenhaus AUF DER BULT | |
Hannover, Lower Saxony, Germany, 30173 |
Study Chair: | Thomas Danne, MD | Kinder- und Jugendkrankenhaus AUF DER BULT |
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 |
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 |
type 1 diabetes pediatrics blood sugar devices |