Self CareFNHNCT03815552
Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth
A study testing Eversense Continuous Glucose Monitoring in people with Self Care, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Self Care
- What is being tested?
- Eversense Continuous Glucose Monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 8 Oct 2018to 11 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kinder- und Jugendkrankenhaus AUF DER BULT
Hanover, Lower Saxony, 30173
About this study
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
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).
Read the 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.
- Conditions
- Self Care
- Being tested
- Eversense Continuous Glucose Monitoring
- Keywords
- type 1 diabetes, pediatrics, blood sugar devices
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eversense Continuous Glucose MonitoringDevice
Also called Senseonics Continuous Glucose Monitoring System
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.
| Study group | Role | What they receive |
|---|---|---|
| Eversense Continuous Glucose Monitoring | Experimental | 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. Receives: Device: Eversense Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
time in range
Reduction of time in range of Glucose < 70-mg/dL when using the Senseonics CGM System
Measured: 90 days
Secondary outcomes (1)
time of hypoglycemia
Percentage time of hypoglycemia (Glucose <70 mg/dL
Measured: three weeks of the blinded phase compared to the last three weeks before 90 days visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start8 Oct 2018
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinderkrankenhaus auf der Bult
- Sponsor type
- University, hospital or other
- Collaborators
- Senseonics, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Danne, MD, Study chair, Kinder- und Jugendkrankenhaus AUF DER BULT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815552
- Sponsor's protocol ID
- IIT-FNH-01
- Acronym
- FNH
- Status last verified
- Oct 2024
- First submitted
- 21 Jan 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03815552
- Acronym / sponsor ID
- FNH / IIT-FNH-01
- Conditions
- Self Care
- Keywords
- type 1 diabetes, pediatrics, blood sugar devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kinderkrankenhaus auf der BultUniversity, hospital or other
- Collaborators
- Senseonics, Inc.
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eversense Continuous Glucose Monitoring | Experimental | Device: Eversense Continuous Glucose MonitoringThe 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eversense Continuous Glucose MonitoringAlso: Senseonics Continuous Glucose Monitoring SystemThe 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. | Device | Eversense Continuous Glucose Monitoring |
Primary outcome
time in range
Time frame: 90 days
Reduction of time in range of Glucose < 70-mg/dL when using the Senseonics CGM System
1 secondary outcome
time of hypoglycemia
Time frame: three weeks of the blinded phase compared to the last three weeks before 90 days visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Danne, MD study chair
Kinder- und Jugendkrankenhaus AUF DER BULT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eversense Continuous Glucose Monitoring in people with Self Care, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time in range (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.