Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabete Mellitus; Medical Device
• Interventions: Device: Prototype 0.3

• Registration Number: NCT03781232
• Lead Sponsor: RSP Systems A/S

Brief Summary

The study was established to collect data and reference measurements in order to establish calibration models for the Prototype 0.3

Detailed Description

Subjects are recruited at two different sites.

Site 1: In group 1 subjects will on their regular stay in the clinic perform four measurement sessions a day. A measurement session consist of a reference capillary blood sample and two measures on the IMD.

Site 2: The study in group 2 consists of 26 home-based measurements and two in-clinic days. During the home measurements, 6 measurement sessions will be performed by the subjects a day. A measurement session consists of two reference BGMs, two reference CGMs and two measurements on the device. On in-clinic visits, subjects will be administered high glucose breakfast and the following 6-7 hours, measurement sessions are performed every 15 minutes.

Study Timeline

• Study First Submitted: 2018-11-21
• Study Start: 2018-11-22
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-19
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• At least 18 years of age
• Have a diagnosis of type 1 or type 2 diabetes mellitus (for RSP-09-02, only patients with type 1 diabetes)
• Skin phototype 1-4
• Be willing to perform a minimum of 6 / 12 (31 during excursion days) finger sticks per day during the study
• Be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol
• Be willing to provide written signed and dated informed consent

Exclusion Criteria

• Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator, due to e.g. known psychiatric diagnoses, lack of cognitive ability, alcohol dependency, drug use, psychosocial overload
• Have known severe allergy to medical grade adhesive or isopropyl alcohol used to clean the skin
• Be breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only)
• Unable to hold hand/arm steadily (including tremors and Parkinson's Disease)
• Severe diabetes related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
• Systemic or topical administration of glucocorticoids for the past 7 days
• Undergoing dialysis treatment
• Have extensive skin changes/diseases at the proposed measurement site (thenar) that could interfere with the accuracy of interstitial glucose measurements
• Have a concomitant medical condition which could interfere with the study devices (study arm 1: intake of acetaminophen study arm 2: intake of salicylic acid or higher doses of ascorbic acid)
• Unsuitable for participation due to any other cause as determined by the Investigator. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation e.g. with required documentation
• Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)

Additional exclusion criteria for study arm 2:

• Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
• Hypoglycemia unawareness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSP-09-01	Prototype 0.3	Enrolled subjects will perform 4 daily measurement session during their regular stay at the clinic. A measurement session consists of a reference capillary blood sample and two measurements on the Prototype 0.3.
RSP-09-02	Prototype 0.3	Enrolled subjects will measure at home for 26 six days and visit the clinic two times. During home measurements, 6 measurement sessions will be performed by the subject a day. A measurement session consists of two BGMs, two CGMs and two measurements on the Prototype 0.3. On in-clinic visits the subject will be administered a high glucose breakfast and the following 6-7 hours, measurement sessions will be performed every 15 minutes.

Primary Outcome Measures

Name	Time	Method
Generation and validation of predictive models by Inter Subject Unified Performance (ISUP).	2 years	Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.; Models will be validated on independent data sets using the ISUP measure.
Generation and validation of predictive models by Mean Absolute Relative Difference (MARD) measures	2 years	Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.; Models will be validated on independent data sets using the MARD measure.

Trial Locations

Locations (2)

m&i-Fachklinik Bad Heilbrunn - Zentrum für Diabetes und Stoffwechselerkrankungen; 🇩🇪 Bad Heilbrunn, Germany

Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm; 🇩🇪 Ulm, Germany