Diabetes MellitusNCT07888582
Effectiveness and Safety of the RIGHTEST™ CGM System for Blood Glucose Management in Persons With Diabetes Mellitus
A study testing RIGHTEST Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by Bionime Corporation at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- RIGHTEST Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 9 Oct 2024to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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
Show all 29Show fewer
- 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.
- Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose excessive risk to study staff. Some examples of conditions that Investigators may consider exclusionary are active illegal substance use; or active psychiatric disorder. Subjects with HIV, Hepatitis B or Hepatitis C infection are excluded from the study.
- 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
- Prior to enrollment, subject has had:
- Severe hypoglycemia resulting in loss of consciousness within past 6 months. Severe hypoglycemia is defined as having low blood glucose levels that require assistance from another person to treat.
- History of Diabetic Ketoacidosis (DKA) within the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis.
- History of a seizure disorder within the last 6 months
- Hypoglycemia unawareness. It presents clinically as the patient's inability to perceive hypoglycemic symptoms.
- Severe diabetes related complications. Such conditions include, but are not limited to, severe macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy.
- Required or scheduled to have a Magnetic Resonance Imagining (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period.
- Insulin-dependent type 2 subjects that receive sodium-glucose cotransporter 2 inhibitor (SGLT2 inhibitor) treatment[15]
- Hematocrit (Hct) level lower than 10% below the normal reference range (*patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents)
- Weight less than 110 pounds (50 kg)
- Participated in another clinical trial within 2 weeks prior to screening or are intending to participate in another clinical trial during the study.
- Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment.
- Legal incompetence or limited legal competence
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, 89081
About this study
Official title: Effectiveness and Safety of the RIGHTEST™ Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
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.
Read more
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
- Being tested
- RIGHTEST Continuous Glucose Monitoring System
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIGHTEST Continuous Glucose Monitoring SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RIGHTEST Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
The percentage of the CGM System raw readings within ±20/20%of paired reference measurements across the device measuring range overall are evaluated.
Measured: 15 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start9 Oct 2024
- Primary completion19 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionime Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888582
- Sponsor's protocol ID
- EU-510-01
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the RIGHTEST™ Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07888582
- Acronym / sponsor ID
- EU-510-01
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bionime CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring System | Experimental | Device: RIGHTEST Continuous Glucose Monitoring SystemAdults 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (29 listed)
- 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:
- Participated in another clinical trial within 2 weeks prior to screening or are intending to participate in another clinical trial during the study.
- Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIGHTEST Continuous Glucose Monitoring SystemAdults 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 | Continuous Glucose Monitoring System |
Primary outcome
accuracy
Time frame: 15 day
The percentage of the CGM System raw readings within ±20/20%of paired reference measurements across the device measuring range overall are evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIGHTEST Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by Bionime Corporation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy (time frame: 15 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.