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

NCT03781232 | Completed

• 1 other identifier: RSP-09
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Diabete Mellitus; Medical Device

Keywords

Non-invasive glucose monitoring; Raman spectroscopy

Outcome Measures

Primary Outcomes (2)

• Generation and validation of predictive models by Inter Subject Unified Performance (ISUP).

  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.

  2 years

• Generation and validation of predictive models by Mean Absolute Relative Difference (MARD) measures

  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.

  2 years

Study Arms (2)

RSP-09-01

EXPERIMENTAL

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.

Device: Prototype 0.3

RSP-09-02

EXPERIMENTAL

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.

Device: Prototype 0.3

Interventions

Prototype 0.3 DEVICE

Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy

RSP-09-01; RSP-09-02

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RSP Systems A/S: lead

Study Sites (2)

m&i-Fachklinik Bad Heilbrunn - Zentrum für Diabetes und Stoffwechselerkrankungen

Bad Heilbrunn, 83670, Germany

Location

Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Guido Freckmann, Dr.

  Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 19, 2018
• Study Start: November 22, 2018
• Primary Completion: August 5, 2019
• Study Completion: August 5, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)