Diabetes (DM)
Conditions
Keywords
diabetes management, continuous glucose monitoring
Brief summary
Single-centre, open label (unblinded). A maximum of 48 patients will be enrolled in 4 Cohorts of 10 patients and 2 potential replacements each. Diabetic patients (type 1 and 2). Duration up to 11 weeks: up to 6 weeks of screening phase (42 days); 4 weeks of treatment/measurement phase (28 days, depending on sensor functionality) and 1 week of follow up (7 days)
Detailed description
This study is an investigational study, which will be conducted only at one site in Germany. The investigators, the patient and the sponsor will be unblinded. The eligibility of the patient is determined in up to two steps, a screening (see inclusion criteria) and in case of women of childbearing potential a urine pregnancy test at the day of sensor insertion (independent of any re-screening). Women of childbearing potential are only enrolled after a negative outcome of the urine pregnancy test. The screening results are valid up to 42 days. Within that time the first measurement visit including the insertion of the device should be performed. If the first measurement visit is delayed a re-screening has to be performed. Should the patient not pass the re-screening, the patient is considered as a screening failure and must be excluded. The trial is structured into three phases, the screening/enrolment phase, the insertion/measurement phase and the follow-up phase. Screening/Enrolment Phase: Up to 6 weeks (42 days), 1 visit Insertion/Measurement phase: Up to 4 weeks (28 days), up to 6 in-house measurement visits Follow-up Phase: 1 week (7 days), 1 visit
Interventions
DEVICEFiberSense System
FiberSense system, a novel CGM system using interstitial fluid (ISF) glucose as an indicator of blood glucose levels by diabetic patients
Sponsors
EyeSense GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index within the range of 19-40 kg/m2, inclusive * Diabetes type 1 and 2 * Females (if of childbearing potential) must agree to abstain from sexual intercourse or use reliable forms of contraception e.g. condom or diaphragm with spermicide or oral contraceptives to prevent pregnancy during the study * Negative urine pregnancy test immediately before sensor insertion (only women of childbearing potential) * Signed written Informed Consent
Exclusion criteria
* Inability to follow the protocol schedule * Participating in another clinical trial * Pregnant or lactating females, , including positive urine pregnancy test immediately before sensor insertion * Any known hypersensitivity to any of the products used in the study, including preservatives etc. Especially hypersensitivity against legumes * Tattoos at the abdominal or upper arm skin area where the fiber sensor is supposed to be placed * Malignancies requiring therapy during the study * Severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study * Acute severe infection disease at the time of enrolment * Alcohol and/or drug addiction * Vulnerable patients (e.g. persons kept in detention) * Poorly controlled diabetes mellitus with hemoglobin A1C higher than 10%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short and mid term performance of the transdermal CGM sensor determined as MARD | 0, 3, 7, 14, 21 and 28 days | Mean absolute relative difference (MARD) of FiberSense system to blood glucose |
| Incidence of adverse events | 0, 3, 7,14, 21, 28 and 35-38 days | Assessment of adverse events and local tolerability occurred during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements | 0, 3, 7, 14, 21 and 28 days | Calculation of MARD of FiberSense against a commercial self-monitoring blood glucose meter |
| Signal-to-noise ratio | 0, 3, 7, 14, 21 and 28 days | — |
| Stability of the blood glucose to fluorescence correlation | 0, 3, 7, 14, 21 and 28 days | FiberSense fluorescence measurement signals calculated in glucose values and compared to glucose values measured with: a: SMBG device (Bayer Contour next USB), b: CGM device (Dexcom Seven plus), c: Laborat orysystem (Hitado Super GL compact) |
| User satisfaction assessed by the Likert scale | 35-38 days | Subjective impression of the patients assessed by 5-point Likert scale (1- strongly agree to 5 - strongly disagree) |
| Signal drift | 0, 3, 7, 14, 21 and 28 days | Drift of the FiberSense fluorescent measurement signals over the wearing time |
| Changes in blood glucose to fluorescence lag time over a period of up to 28 days | 0, 3, 7, 14, 21 and 28 days | Lag time (in minutes) between FiberSense readings and corresponding laboratory blood glucose values during glucose excursions |
Countries
Germany
Outcome results
None listed