Diabetes
Conditions
Brief summary
Mono-centre, open label (unblinded). 8 patients + 2 potential replacements. Duration up to 9 weeks: up to 6 weeks screening (42 days), 2 weeks of treatment (14 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. As soon as the eligibility of the patient is confirmed the patient is enrolled. 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: 6 weeks (42 days), 1 visit Insertion/Measurement phase: Up to 2 weeks (14days), up to 6 measurement visits Follow-up Phase: 1 week (7 days), 1 visit
Interventions
DEVICEBellySense
BellySense is a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.
Sponsors
EyeSense GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 * Signed written Informed Consent
Exclusion criteria
* Inability to follow the protocol schedule * Participating in another clinical trial, if it is not a non-investigational clinical study (NICS) * Pregnant or lactating females, * Any known hypersensitivity to any of the products used in the study, including preservatives etc. * 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 abuses * 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 |
|---|---|---|
| Correlation between blood glucose and interstitial fluid (ISF) glucose concentration | 6 measurements within 14 days | Mean absolute relative difference (MARD) of fluorescence sensor values and laboratory blood glucose values |
| Adverse event reporting | 14 days | Incidence of reported ADE, with focus on number of SADE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements | 6 measurements within 14 days | Mean absolute relative difference (MARD) of fluorescence sensor values and capillary blood glucose values |
| Signal to noise ratio | 6 measurements within 14 days | — |
| Lag time | 6 measurements within 14 days | Determine changes in blood glucose to fluorescence lag time (in minutes) |
| Patient impression | after 14 days | Subjective impression of the patients assesed by 5/6-point scale |
| Signal drift | 6 measurements within 14 days | — |
| Stability of measurements | 6 measurements within 14 days | Stability of the FiberSense fluorescence measurement signals over the wearing time |
Countries
Germany
Outcome results
None listed