The purpose of this clinical investigation is to evaluate the effectiveness of modified Sensor designs on the longevity (up to a maximum of 90 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this investigation is to assess accuracy and longevity
of the Senseonics CGM System modifications and to assess safety of the
Senseonics CGM System during up to 90days of Sensor use in the clinic and
during home use.
System modifications include evaluating the biocompatible coatings
hydroxyethylmethacrylate (HEMA) and polyethylene glycol diacrylate (PEG) with
or without PET. These coatings are on the outer surface of the Sensor and are
designed to improve the accuracy and/or longevity of the
System.
Secondary outcome
The secondary objectives of this investigation are as follows:
• To determine other relevant Senseonics CGM System performance measures.
• To evaluate the incidence of procedure and device-related adverse events in
clinic and home use.
• To evaluate the incidence of all adverse events in clinic and home use.
Background summary
Diabetes, unless carefully monitored and treated, can cause severe, long-term
medical complications. It is the leading cause of adult blindness, end-stage
renal disease and lower-limb amputations, and significantly increases the risk
for heart disease and stroke. Compliance with
glucose monitoring regimens is one of the key tools for improving metabolic
control. The current standard glucose-monitoring regimen for patients with
diabetes involves obtaining a *fingerstick* or alternative blood glucose
multiple times a day to obtain a capillary blood sample for testing.
According to the International Society of Pediatric and Adolescent Diabetes
(ISPAD), *successful application of intensified diabetes management with
multiple injection therapy or insulin infusion therapy requires frequent
self-monitoring of blood glucose (four to six times a day) and regular,
frequent review of the results to identify patterns requiring adjustment to the
diabetes treatment plan.* Despite this diagnostic procedure and therapeutic
intervention, glucose values of patients with diabetes fluctuate widely
throughout the day. In addition, the uncomfortable, cumbersome
nature of this test regimen leads to poor compliance of the patients with this
procedure.
Study objective
The purpose of this clinical investigation is to evaluate the effectiveness of
modified Sensor designs on the longevity (up to a maximum of 90 days) of the
Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will
also evaluate the safety of the Senseonics CGM System during clinical use as
well as during home use with a blinded display.
Study design
This is a display-blinded, single-center, prospective clinical study in 12
subjects. Subjects will be screened for inclusion and exclusion criteria and
informed consent obtained. Each subject will have two Sensors inserted
subcutaneously on Day 0 (upper arm(s) and/or abdomen). Inserted devices will
remain in-vivo for a period of up to 90 days. Sensors inserted in all subjects
will be powered and read in-vivo, as well as tested in-vitro after removal, to
further quantify Sensor performance. Subjects will also be issued a home blood
glucose meter for use in the clinic and at home during the home wear portion.
Intervention
LET OP VANAF HIER MOET NOG!
Subjects will receive two Sensor insertions during Visit 2 (Day 0). Subjects
will not be required to fast prior to the visit. Vital signs, fingerstick
glucose and β-HOB (β-hydroxybutyrate) levels will be measured. If the subject
is female, a urine HCG test will be performed. If the subject meets in-clinic
visit eligibility criteria, he/she will proceed with two Sensor insertions
according to the methods described in Appendix 2. Subjects will have 2 Sensors
inserted in the upper arms and/or abdomen. Readers will be placed over the
Sensors and readings will be taken for approximately 2 hours. Subjects will be
assigned a study SMBG (self monitored blood glucose) meter and will be trained
on its proper use.
Study burden and risks
This investigation will be conducted by investigators who are qualified by
training and experience in the treatment of diabetes mellitus. In addition,
adequate measures including eligibility criteria limitations, subject screening
and pre-visit assessment of the diabetic condition have been
incorporated into the clinical investigation to minimize such risks.
Investigators have also been trained in the technique for Sensor insertion and
removal. Investigators will examine the insertion site during each in-clinic
visit and document any suspected adverse event. Subjects will be instructed to
contact the clinic immediately upon any sign of extreme irritation or
discomfort. Furthermore, potential risks associated with participation in this
investigation will be minimized and managed in accordance with ISO 14155:
Clinical Investigation of Medical Devices for Human Subjects - Good Clinical
Practices, regulations imposed by the Competent Authority and requirements of
the approving Ethics Committee(s).
The Sponsor believes that any potential risk presented by this investigation
has been minimized and that adequate testing, safeguards, and safety monitoring
have been incorporated into the investigation to further minimize and mitigate
the risks.
The Sponsor firmly believes that the value of the knowledge to be gained by
conducting this clinical investigation to demonstrate the safety and accuracy
of the Senseonics CGM System outweighs the potential risks posed to
participating subjects.
Seneca Meadows Parkway 20451
Germantown MD 20876
US
Seneca Meadows Parkway 20451
Germantown MD 20876
US
Listed location countries
Age
Inclusion criteria
1. Females and males aged >=18 to <=65 years of age.
2. Clinically confirmed diagnosis of Type 1 diabetes mellitus (for at least 1 year of duration)
on multiple daily injections (>2 injections per day) or on insulin pump therapy.
3. HbA1c <=10%.
4. Subject understands study procedures and risks, is willing to comply with protocol
requirements, and has signed an informed consent document.
Exclusion criteria
Subjects will be denied participation in the investigation if they meet any of the following key,
exclusion criteria:
1. History of severe hypoglycemia in the 6 months immediately prior to study start.
2. Severe diabetic Ketoacidosis in the past 6 months.
3. Females who are lactating, pregnant or intending to become pregnant during the course
of the investigation, defined as
3.1 Not postmenopausal for at least 1 year OR
3.2 Not surgically sterile, OR
3.3 If of child bearing potential, the subject is not practicing birth control, not willing to
avoid pregnancy for the period of study participation, has a positive serum pregnancy test
at screening or has a positive urine pregnancy test at the time of the Sensor insertion
procedure.
4. Any condition preventing or complicating the placement, operation or removal of the
Sensor, including but not limited to:
4.1 Upper extremity deformities that would impede the placement of the Sensor or
application of the external Reader.
4.2 Any skin condition that may affect Sensor insertion or external Reader placement.
5. Any medical condition or illness that in the judgment of the investigator might interfere
with the procedures, results or compliance during the course of this investigation, or
increase the risk of induced hypoglycemia or repeated blood testing, including but not
limited to:
5.1 Anemia, defined as either:
5.1.1 Hemoglobin (Hgb) value for females of < 12.0 g/dl, for males < 13.0 g/dl OR
5.1.2 Abnormal red cell indices and iron deficiency.
5.2 History of hepatitis B, hepatitis C or HIV.
5.3 Symptomatic coronary artery disease, unstable angina, myocardial infarction or stroke
within 6 months of screening, uncontrolled hypertension, or congestive heart failure.
5.4 Any seizure disorder.
5.5 History of adrenal insufficiency.
5.6 Significantly impaired hepatic function
5.7 Renal failure, defined as any prior dialysis or an estimated glomerular filtration rate
(eGFR) below 60 mL/min per 1.73 m2 using CKD-EPI formula (Levey et al, 2009)
6. Known microvascular (diabetic) complications (other than non-proliferative retinopathy),
including active proliferative diabetic retinopathy or macular edema, non-proliferative
retinopathy stage 3, diabetic nephropathy (other than microalbuminuria with normal
creatinine), gastroparesis or neuropathy requiring treatment.
7. Currently receiving any of the following therapies, or likely to need such treatment during
the follow-up period of this study:
7.1 Immunosuppressant therapy
7.2 Chemotherapy for any form of cancer
7.3 Anti-coagulant therapy (e.g. Plavix, LMW heparin, coumadin)
7.4. Chronic systemic glucocorticoids (excluding topical, optical or nasal, but including
inhaled)
7.5. Antibiotic treatment for chronic infection (e.g. osteomyelitis)
8. Magnesium <1.6 mg/dL at screening.
9. Potassium <3.4 mmol/L at screening.
10. Hematocrit >50% or <30% at screening.
11. Topical or local anesthetic allergy.
12. Known current or recent alcohol or drug abuse by subject history.
13. Participation in another clinical investigation within 30 days preceding screening, or
intention to participate in any other clinical investigation during the period of this study.
14. The presence of any other active implanted device, whether turned on or off. Passive
implants are allowed.
15. A condition requiring or likely to require the use of magnetic resonance imaging (MRI).
16. Positive drug screen results
17. Any condition that in the investigator*s opinion would make the subject unable to
complete the study. Investigator will supply rationale.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42737.041.12 |