Clinical and Home Use Feasibility Study of a Percutaneous Optical Glucose Fiber Sensor

NCT04152408 | Completed DMC

• 1 other identifier: P-4.3-C-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, open label (unblinded) prospective study investigating the performance and safety of FiberSense system in diabetic patients (Typ I and II). In the period of up to 30 days the performance of the FiberSense system is evaluated against laboratory gold standard method during 6 in-clinic sessions.

Conditions

Diabetes (DM)

Keywords

diabetes management; continuous glucose monitoring

Outcome Measures

Primary Outcomes (3)

• Performance of the FiberSense system as compared with laboratory gold standard reference (LGSR)

  Point accuracy of the FiberSense system as determined by proportion of CGM readings within ≤15% of the LGSR reading for blood glucose levels \>100 mg/dl, and within ≤15 mg/dl of the LGSR reading for blood glucose levels ≤100 mg/dl, for paired samples taken during the in-clinic sessions.

  at 1, 3, 7, 14, 21 and 28 days

• Duration of use of the FiberSense system

  Duration of use of the FiberSense device in average and by individual patients

  30 days

• Incidence of (Serious) Adverse Events

  Adverse Events reporting and local tolerability as assessed by Draize's scale

  30 days

Secondary Outcomes (9)

• Mean and Median Relative Differences in FiberSense measured glucose from LGSR

  at 1, 3, 7, 14, 21 and 28 days

• Mean and Median Absolute Relative Differences in FiberSense measured glucose from reference laboratory standard

  at 1, 3, 7, 14, 21 and 28 days

• Hypoglycemia (<75 mg/dl (14)) and hyperglycemia (>180 mg/dl (14)) detection rates

  at 1, 3, 7, 14, 21 and 28 days

• Hypoglycemia (<75 mg/dl) and hyperglycemia (>180 mg/dl,) missed detection rates

  at 1, 3, 7, 14, 21 and 28 days

• Accuracy of glucose rate of change of FiberSense sensor compared to glucose rate of change of reference laboratory standard

  at 1, 3, 7, 14, 21 and 28 days

Study Arms (1)

FiberSense System

EXPERIMENTAL

6 diabetic patients will wear a FiberSense system at the upper arm for up to 30 days. and a comparator CGM system at the abdomen (replaced every 7 days).

Device: FiberSense System

Interventions

FiberSense System DEVICE

FiberSense system, a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.

FiberSense System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age ≥ 18 years old.
• Type I or II diabetes mellitus.
• Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study. If of child bearing potential, the patient 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 for the length of the clinical study.
• Willingness, ability and commitment to comply with the testing procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits, use of pre-specified glucose monitoring device.
• Willingness to abstain from swimming during their participation in the measurement phase.
• Willingness to abstain from air travelling during their participation in the measurement phase.
• Willingness to avoid strong magnetic and electrical fields as well as proximity to sensitive medical devices due to the possible electromagnetic interference during their participation in the measurement phase.
• In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
• Written informed consent to participate in the study provided by the patient.

You may not qualify if:

• Poorly controlled diabetes mellitus with HbA1C \>10%.
• Known microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as e.g. history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (with glomerular filtration rate (eGFR) \< 45 ml/min) or neuropathy requiring treatment.
• History of significant hypoglycemia unawareness, or a history of severe hypoglycemia (requiring emergency medical intervention) within the last 6 months.
• Currently pregnant, as demonstrated by a positive pregnancy test at screening and prior to enrollment.
• Impaired hepatic function measured as aspartate aminotransferase (AST) ≥ three times the upper reference limit.
• Impaired renal function measured as creatinine \> 1.2 times above the upper limit of normal.
• Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
• Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
• Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
• Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
• Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
• Known current or recent alcohol or drug abuse
• Blood donation of more than 500 ml within the last three months
• Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
• Has a MRI scan, CT scan, diathermy or flight scheduled during the proposed study participation.

Sponsors & Collaborators

• EyeSense GmbH: lead

Study Sites (1)

Diabetes Institut Heidelberg

Heidelberg, 69115, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christoph Hasslacher, Prof. Dr.

  Diabetes Institut Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 5, 2019
• Study Start: January 1, 2017
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)