Diabetes MellitusNCT05158478
Hematocrit Effect on a Blood Glucose Monitor
A study testing blood glucose measurement, blood glucose monitor for personal use and blood glucose measurement, laboratory reference device in people with Diabetes Mellitus, run by Institut fur Diabetes Karlsburg GmbH at 1 site in Germany.
Trial summary
This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- blood glucose measurement, blood glucose monitor for personal use and blood glucose measurement, laboratory reference device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 22 Feb 2022to 14 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients with clinical indication for blood glucose testing
- Signed form of consent
- Minimum age of 18 years
- Subjects are legally competent and capable to understand character, meaning and consequences of the study
Who cannot join
- Pregnancy or lactation
- Severe acute disease (at study physician's discretion)
- Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
- Current constitution that does not allow participating in the study (e.g. hematocrit out of
- the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
- Being unable to give informed consent
- Age younger than 18 years
- Legally incompetent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, 17495
About this study
Official title: Evaluation of the Hematocrit Effect on the Blood Glucose Monitor for Personal Use JT100
This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197
Read the detailed description
This study assesses the repeatability precision the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines
- Conditions
- Diabetes Mellitus
- Being tested
- blood glucose measurement, blood glucose monitor for personal use, blood glucose measurement, laboratory reference device
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood glucose measurement, blood glucose monitor for personal useDiagnostic test
Also called measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)
measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)
blood glucose measurement, laboratory reference deviceDiagnostic test
measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)
| Study group | Role | What they receive |
|---|---|---|
| Subject glucometer measurement | Experimental | Not described Receives: Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use; Diagnostic Test: blood glucose measurement, laboratory reference device |
What is being measured
The primary outcome is the main question the study is designed to answer.
repeatability precision
Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start22 Feb 2022
- Primary completion22 Feb 2022
- Study completion14 Mar 2022
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fur Diabetes Karlsburg GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
- Responsible party
- Principal investigator, Matthes Kenning, Institut fur Diabetes Karlsburg GmbH
- Investigators
- Eckhard Salzsieder, PhD, Study director, Institut fur Diabetes Karlsburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158478
- Sponsor's protocol ID
- IDK_ISO_2021_005
- Status last verified
- Jul 2022
- First submitted
- 2 Dec 2021
- Last updated
- 28 Jul 2022
- 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 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hematocrit Effect on the Blood Glucose Monitor for Personal Use JT100
- ClinicalTrials.gov ID
- NCT05158478
- Acronym / sponsor ID
- IDK_ISO_2021_005
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Institut fur Diabetes Karlsburg GmbHUniversity, hospital or other
- Collaborators
- Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 15 Dec 2021 (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.
This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197
Detailed description
This study assesses the repeatability precision the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject glucometer measurement | Experimental | Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use, Diagnostic Test: blood glucose measurement, laboratory reference device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients with clinical indication for blood glucose testing
- Signed form of consent
- Minimum age of 18 years
- Subjects are legally competent and capable to understand character, meaning and consequences of the study
Key exclusion criteria (8 listed)
- Pregnancy or lactation
- Severe acute disease (at study physician's discretion)
- Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
- Current constitution that does not allow participating in the study (e.g. hematocrit out of
- the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
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 |
|---|---|---|
| blood glucose measurement, blood glucose monitor for personal useAlso: measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100) | Diagnostic test | Subject glucometer measurement |
| blood glucose measurement, laboratory reference devicemeasurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus) | Diagnostic test | Subject glucometer measurement |
Primary outcome
repeatability precision
Time frame: day 1
Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197
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 28 Jul 2022.
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.
Eckhard Salzsieder, PhD study director
Institut fur Diabetes Karlsburg GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood glucose measurement, blood glucose monitor for personal use and blood glucose measurement, laboratory reference device in people with Diabetes Mellitus, run by Institut fur Diabetes Karlsburg GmbH 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 4 inclusion and 8 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 28 Jul 2022. 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?
repeatability precision (time frame: day 1). 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 28 Jul 2022.