Effectiveness and Safety of the RIGHTEST™ CGM System for Blood Glucose Management in Persons With Diabetes Mellitus

NCT07888582 | Completed

• 1 other identifier: EU-510-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is expected to enroll 50 confirmed cases of type 1 or type 2 diabetes. All eligible subjects must wear a continuous glucose monitoring system on both the left and right upper arms for a maximum of 15 days (360 hours) and adhere to the clinical visit protocol. After enrollment, all subjects will be randomly assigned to either Group A or Group B to determine the time points for clinical visits. All subjects will have venous blood drawn on days 1, days 5 (±1), 10 (±1), and 15 (-1) post-wearing. All subjects will remove all devices on day 15 (-1) based on system prompts and undergo a telephone follow-up on day 4 (±3) thereafter. This clinical trial does not involve long-term follow-up. During the trial, the blood glucose values measured by the "continuous glucose monitoring system" worn by the subjects will be analyzed against the YSI venous blood glucose values measured at the medical institution on days 1, 5 (±1), 10 (±1), and 15 (-1) as control reference values. This analysis aims to evaluate the accuracy, repeatability, stability, high and low blood glucose event alerts, and safety of the continuous glucose monitoring system. Additionally, fingertip blood glucose measurements taken by subjects during home use will be collected to assess the operational feasibility of the continuous glucose monitoring system in a home setting.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• accuracy

  The percentage of the CGM System raw readings within ±20/20%of paired reference measurements across the device measuring range overall are evaluated.

  15 day

Study Arms (1)

Continuous Glucose Monitoring System

EXPERIMENTAL

Adults with type 1 or type 2 diabetes mellitus wore two RIGHTEST (HM510) CGM sensors, one on each upper arm, for up to 15 days. Device accuracy was evaluated against venous blood glucose measurements during four in-clinic frequent blood sampling visits.

Device: RIGHTEST Continuous Glucose Monitoring System

Interventions

RIGHTEST Continuous Glucose Monitoring System DEVICE

Adults with type 1 or type 2 diabetes mellitus wore two RIGHTEST (HM510) CGM sensors, one on each upper arm, for up to 15 days. Device accuracy was evaluated against venous blood glucose measurements during four in-clinic frequent blood sampling visits.

Continuous Glucose Monitoring System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 18 years and older at time of enrollment.
• Subjects must have a diagnosis of type 1 or type 2 diabetes mellitus for a minimum of 6 months and require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 1 injection daily).
• Subjects must be available to participate in all clinical sessions with the following parameters:
• Subject must be able to fast for a minimum of 6 hours prior to Visit 1 (Screening Visit).
• Subject must be willing to perform a minimum of 4 fingerstick measurements per day.
• Subject must be willing to wear 1 Sensor on each upper arm simultaneously.
• Have adequate venous access as assessed by Investigator or appropriate staff
• Subjects must be willing to have their glucose levels manipulated into high and low glucose levels via carbohydrate consumption, meal time, activity levels and/or insulin dosing during each in-clinic visit.
• Subjects with type 1 diabetes mellitus must be qualified by the Investigator as appropriate to perform the glucose challenge. Subjects with type 2 diabetes can be exempt from glucose challenges.
• Subjects with type 1 diabetes mellitus must have a known treatment regimen with a target glucose concentration and a known insulin sensitivity factor
• In the Investigator's opinion, subjects must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
• Subjects must be willing and able to provide signed written consent.
• Subjects must be able to speak, read and write German.

You may not qualify if:

• Known allergy and not able to tolerate to medical grade tape adhesive.
• Presence and unresolved of extensive skin changes/diseases at Sensor wear site(s) that preclude wearing the Sensor(s) on skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, or dermatitis herpetiformis);
• Subjects who have or are:
• Female of child-bearing potential age:
• Has a positive pregnancy screening test no more than 72 hours prior to the Insertion Visit
• Who is sexually active should be excluded if she is not using a form of contraception deemed reliable by the Investigator
• That plans to become pregnant during the course of study.
• Diagnosed with hemophilia or any other bleeding disorders
• Acute or chronic kidney disease (Estimated eGFR less than 30 mL/min/1.73m2).
• End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the course of study.
• Any history of psychiatric conditions that, in the opinion of the Investigator, would pose a risk for participation or interfere with compliance in this study.
• Adrenal Insufficiency
• Current or know history of coronary artery or cardiovascular disease that is not stable with medical management including but not limited to being implanted with a pacemaker, advanced congestive heart failure, recent stroke, myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, ventricular rhythm disturbances or thromboembolic disease.
• Anticoagulant treatment and platelet inhibition (with the exception of acetylsalicylic acid (ASS, daily dose rate \<300 mg), Phenprocoumon (e.g. Marcumar), NOAK (e.g. Dabigatran,Rivaroxaban)
• Chronic use of steroids in adrenal suppressive doses

Sponsors & Collaborators

• Bionime Corporation: lead

Study Sites (1)

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

Ulm, Baden-Wurttemberg, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: October 22, 2026
• Study Start: October 9, 2024
• Primary Completion: December 19, 2024
• Study Completion: December 23, 2024
• Last Updated: October 22, 2026

Record last verified: 2026-10

Locations

DE (1)