Diabetes Mellitus Type 1NCT01508065
Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
An observational study of Diabetes Mellitus Type 1, run by GlucoVista at 2 sites in Israel.
Trial summary
Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that can be achieved with a true non-invasive device offering the likelihood of continuous glucose monitoring. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Glucometer CGM-305
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2012to Jul 2014
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population will include subjects with controlled type one diabetes mellitus.
Who may be able to join
- Type 1 Diabetic patient.
- Ages: 18 to 65.
- Signed informed consent.
- HbA1c of 6%-9% at screening.
- Males- not involved in active military duty.
- Females-non-child bearing potential or females of child-bearing potential who have a negative pregnancy test (HCG in blood or urine) within 72 hours of informed consent.
Who cannot join
- Active systemic or local infection.
- Any medical condition that, by the investigator judgment, will increase the risk from Hyper and Hypo-Glycemic experiment: seizures, heart disease, hypoglycemia unawareness etc.
- History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
- Not yet recruiting
Hadassah Medical Organization
Jerusalem
About this study
Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that can be achieved with a true non-invasive device offering the likelihood of continuous glucose monitoring. Currently, glucose is best monitored by measuring capillary blood from the fingertips, from venous/arterial line blood samples and from a daily calibrated Subcutaneous Blood Glucose Monitor (SBGM) which is a source of severe inconvenience and hence, a lack of compliance.
Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.
Read more
The Glucometer CGM-305 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.
The primary objectives of the trial are to determine:
- The safety of the Glucometer CGM-305 in evaluating blood glucose levels
- The accuracy of the Glucometer CGM-305 in evaluating blood glucose levels
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Glucometer CGM-305
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucometer CGM-305Device
The study procedure consists of three days trial. After each experimental day the results of blood glucose level reading from the non-invasive Glucometer CGM-305 will be compared to the reading from several devices, as following: Abbott Freestyle Libre, the hexokinase assay (YSI 2300 STAT Plus) from the venous and the laboratory blood measurements. First day of trial consists of 8-10 hours and is used to calibrate the non-invasive Glucometer CGM-305 for the specific patient. During the second and third days a fasting experiment is performed and consists of 4-6 hours.
| Study group | Role | What they receive |
|---|---|---|
| controlled type one diabetes mellitus. | Not described Receives: Device: Glucometer CGM-305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by mean relative error when compared to venous blood glucose measured by a laboratory device.
Measured: will be assessed after second experimental day
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by correlation with values measured by glucose hexokinase based assay
Measured: will be assessed after second experimental day
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by Clark error grid with measurements of venous blood as the comparing value
Measured: will be assessed after second experimental day
Secondary outcomes (1)
The safety of the Glucometer CGM-305 in evaluating blood glucose levels
Safety will be evaluated in a descriptive manner by recording all adverse events in the patient population by number and severity.
The study will evaluate safety by assessing:
- Device related adverse events: local and systemic effects of the Glucometer CGM-305 including: redness, burns, pain , or other complications.
- General adverse events: Adverse events not directly related to the Glucometer CGM-305 device but are related to the study procedure (i.e clamping), such as: local infection, blood clot, bleeding, hypoglycemia.
Measured: The study consists of three days trial, first day lasts an 8-10 hours, second and third days last 4-6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlucoVista
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508065
- Sponsor's protocol ID
- gluco01
- Status last verified
- Feb 2019
- First submitted
- 9 Jan 2012
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
- ClinicalTrials.gov ID
- NCT01508065
- Acronym / sponsor ID
- gluco01
- Conditions
- Diabetes Mellitus Type 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- GlucoVistaIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- First posted
- 11 Jan 2012 (estimated)
- 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.
Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that can be achieved with a true non-invasive device offering the likelihood of continuous glucose monitoring. Currently, glucose is best monitored by measuring capillary blood from the fingertips, from venous/arterial line blood samples and from a daily calibrated Subcutaneous Blood Glucose Monitor (SBGM) which is a source of severe inconvenience and hence, a lack of compliance.
Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.
The Glucometer CGM-305 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.
The primary objectives of the trial are to determine:
- The safety of the Glucometer CGM-305 in evaluating blood glucose levels
- The accuracy of the Glucometer CGM-305 in evaluating blood glucose levels
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| controlled type one diabetes mellitus. | – | Device: Glucometer CGM-305 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population will include subjects with controlled type one diabetes mellitus.
Key inclusion criteria (6 listed)
- Type 1 Diabetic patient.
- Ages: 18 to 65.
- Signed informed consent.
- HbA1c of 6%-9% at screening.
- Males- not involved in active military duty.
Key exclusion criteria (3 listed)
- Active systemic or local infection.
- Any medical condition that, by the investigator judgment, will increase the risk from Hyper and Hypo-Glycemic experiment: seizures, heart disease, hypoglycemia unawareness etc.
- History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
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 |
|---|---|---|
| Glucometer CGM-305The study procedure consists of three days trial. After each experimental day the results of blood glucose level reading from the non-invasive Glucometer CGM-305 will be compared to the reading from several devices, as following: Abbott Freestyle Libre, the hexokinase assay (YSI 2300 STAT Plus) from the venous and the laboratory blood measurements. First day of trial consists of 8-10 hours and is used to calibrate the non-invasive Glucometer CGM-305 for the specific patient. During the second and third days a fasting experiment is performed and consists of 4-6 hours. | Device | controlled type one diabetes mellitus. |
Primary outcome
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by mean relative error when compared to venous blood glucose measured by a laboratory device.
Time frame: will be assessed after second experimental day
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by correlation with values measured by glucose hexokinase based assay
Time frame: will be assessed after second experimental day
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by Clark error grid with measurements of venous blood as the comparing value
Time frame: will be assessed after second experimental day
1 secondary outcome
The safety of the Glucometer CGM-305 in evaluating blood glucose levels
Time frame: The study consists of three days trial, first day lasts an 8-10 hours, second and third days last 4-6 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 1, run by GlucoVista at 2 sites in Israel.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadas Lamberg, PhD (00 972 2 6777572, lhadas@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by mean relative error when compared to venous blood glucose measured by a laboratory device. (time frame: will be assessed after second experimental day). The study lists 3 primary outcomes in all. 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 20 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.