Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03781232
Other study ID # RSP-09
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2018
Est. completion date August 5, 2019

Study information

Verified date December 2019
Source RSP Systems A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date August 5, 2019
Est. primary completion date August 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany 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

Sponsors (1)

Lead Sponsor Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05563090 - Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
Recruiting NCT05333159 - The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.
Active, not recruiting NCT03119584 - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation Phase 4
Completed NCT04409171 - Glucose Metabolism After Partial Pancreatectomy
Recruiting NCT06060392 - Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus N/A
Completed NCT05144971 - StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
Completed NCT03914183 - Can mCPN Intervention Improve Injection Site Rotation N/A
Not yet recruiting NCT06150508 - Randomized Controlled Trial of the Smart O2O Model Development for Chronic Diseases Management Through Digital Health N/A
Completed NCT01252810 - Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure Phase 2
Active, not recruiting NCT04171557 - Bicycling and Mortality Among Individuals With diabetesNutrition (EPIC)
Active, not recruiting NCT03155594 - CGM to Aid Transition From Inpatient to Outpatient N/A
Completed NCT04864327 - Smoking Intervention Among Patients With Diabetes N/A
Completed NCT04407182 - Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients Infected by SARS-Cov-2 With COVID-19 Phase 2
Completed NCT05752591 - Hypothalamic-pituitary Dysfunction in Diabetes
Completed NCT03159546 - FreeStyle Libre Flash Glucose Monitoring System Accuracy N/A
Completed NCT03953092 - A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699 Phase 1
Not yet recruiting NCT06262854 - Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study N/A
Completed NCT03934281 - Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient N/A
Not yet recruiting NCT03341026 - Metronom Continuous Glucose Monitoring System N/A
Recruiting NCT03965975 - Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device N/A