An observational study in Glucose Metabolism Disorders and Diabetes Mellitus, sponsored by Tirat Carmel Mental Health Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Tirat Carmel Mental Health Center · Observational
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Among 189 studies in Diabetes Mellitus with a site in Israel — 9 open to participants now, 12 under way, 2 of them phase 3. Diabetes Mellitus · Israel.
Among the 189 studies in Diabetes Mellitus with a site in Israel, this one is the 23rd largest by enrollment of the 43 observational ones that give a count, is one of 10 that started in 2017, is one of 44 observational ones, and was the 150th registered.
8,292 studies on the registry are indexed under Diabetes Mellitus; 1,074 are open to participants now.
Browse Diabetes Mellitus studies →9 of the 189 studies in Diabetes Mellitus with a site in Israel are open now. Recruiting first, the newest first:
Mapi Pharma Ltd. · Sites in Israel
Ages 18–64
Medtronic MiniMed, Inc. · Sites in Israel, Belgium, Denmark and 1 more country
Ages 2+
Western Galilee Hospital-Nahariya · Sites in Israel
Ages 18+ · Healthy volunteers
CSL Behring · Sites in Israel, United States, Argentina and 32 more countries
Ages 18+
Rabin Medical Center · Sites in Israel
Ages 2–45 · Healthy volunteers
A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →
Of the 650 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
189 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 25 · Phase 3 60 · Phase 4 17
First in 1994; this study’s year is marked. 10 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 210 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Median enrollment 199 across the 145 interventional studies, 260 across the 43 observational. Of the 131 that completed or were terminated, 61 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
108 of 189 have an industry lead sponsor. The 10 most frequent:
Tirat Carmel Mental Health Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
Tirat Carmel Mental Health Center has 1 study filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetes Mellitus with a site in Israel that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07227805Medtronic MiniMed, Inc.Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS) | 2027-03-17 |
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Among the 189 studies in Diabetes Mellitus with a site in Israel, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Diabetes mellitus (or diabetes) is a chronic, metabolic disease characterized by elevated levels of blood glucose. Patients with diabetes need to monitor their blood glucose level several times a day to control their medical state. Modern biosensors have become a promising solution for non-invasive blood glucose measurements. This study aims to validate the efficacy and the accuracy of Glucometry Monitor (NIGM) developed by Spectrophon LTD incorporated in smart watches.
Method Participants will use Spectrophon biosensors to non-invasively estimate the level of glucose in blood. Blood will also be collected and the glucose level will be checked with commercially available blood glucose analyzers . All sets of data will be compared to estimate the accuracy of measurements of Spectrophon NIGM
Diabetes is a chronic, life-long disease that represents a major public health challenge at a world level (Matthews et al 1985). It is important to note that diabetes is common among mentally ill patients, especially among patients with schizophrenia that are treated with new generation antipsychotic drugs (Nielsen et al 2010, Vancampfort et al 2016).
To maintain blood glucose level homeostasis, repeated blood glucose testing is needed. The vast majorities of currently available methods for blood glucose testing are invasive and cause discomfort for patients. However, biosensors have recently become a promising solution for non-invasive glucose blood testing (Bandodkar et al 2014; Zhang et al 2015). Spectrophon LTD has developed a technology that allows measurement of even the smallest amounts of various compounds contained in sweat. Using unique algorithm developed by Spectrophon LTD, these data provides the possibility of evaluating the levels of chemicals in the bloodstream. Based on this technology, Spectrophone LTD has developed a glucometer biosensor that is able to non-invasively detect the blood glucose level. This glucometer biosensor can be easily incorporated into most commercially available smartwatches. Development of this technology will allow real-time, non-invasive measurement of blood glucose level and will dramatically facilitate effective treatment of diabetes. In addition, this technology will enable monitoring of glucose levels in patients with mental disorders that will facilitate the early detection of metabolic syndrome.
Study Design: this naturalistic study will examine the accuracy of Spectrophon NIGM incorporated in smart watch Samsung Gear S2 that non-invasively and indirectly detect the level of glucose in human blood. The study will be held in Maale Carmel Mental Health Center (MCMHC). Adult participants (n=200) will be recruited for the study from the staff of MCMHC (including doctors, nurses and administrative workers; no psychiatric in-patients will be recruited for the study). In parallel to glucose measurements with NIGM, blood will be collected and the glucose level will be checked using commercially available blood glucose analyzers.
The participants will be able to select between two options for blood collection:
The first option: intravenous cannula (Venflon) will be inserted in cubital vein and blood will be collected twice in the beginning and at the end of the procedure (within 1-3 hours) and checked for the glucose level with commercially available blood glucose analyzers.
The second option: The blood will be collected twice from the cubital vein at the beginning and at the end of the procedure (within 1-3 hours) and checked for the glucose level using commercially available blood glucose analyzers .
The measurements will be performed twice: before meal (subject should be in fasting state) and after meal with one hour interval between two measurements.
The results of the measurements of the NIGM will be compared to the results obtained from commercially available blood glucose analyzers.
The application automatically saves every measurement into archive. To better control the process, the manual fixation of data obtained by NIGM is performed.
8,292 studies on the registry are indexed under Diabetes Mellitus; 1,074 are open to participants now.
This study's enrollment of 210 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Tirat Carmel Mental Health Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
Compared within Diabetes Mellitus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Glucose Metabolism Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Israeli and non-israeli citizens of age 18-75.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wearable smartwatch with integrated non-invasive glucose detection system
Reference commercial glucometer
Percentage of Measurements With < 15% Error
Difference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300
Time frame: 1-3 hours
| Milestone | Blood Collection (Healthy Individuals) | Blood Collection (Diabetic Patients) |
|---|---|---|
| Started | 200 | 10 |
| Completed | 200 | 10 |
| Not completed | 0 | 0 |
Difference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300
| Percentage of measures with error <15% | Blood Collection (Healthy Individuals) | Blood Collection (Diabetic Patients) |
|---|---|---|
| Algorithm 1.7 | 95.25 | 100 |
| Algorithm 1.6 | 94.5 | 100 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blood Collection (Healthy Individuals) | 0/200 (0%) | 0/200 (0%) | 0/200 (0%) |
| Blood Collection (Diabetic Patients) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Blood Collection (Healthy Individuals) | Blood Collection (Diabetic Patients) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 188 | 7 | 195 |
| >=65 years | 12 | 3 | 15 |
| Sex: Female, Male(Participants) | Blood Collection (Healthy Individuals) | Blood Collection (Diabetic Patients) | Total |
|---|---|---|---|
| Female | 114 | 7 | 121 |
| Male | 86 | 3 | 89 |
| Race and Ethnicity Not Collected(Participants) | Blood Collection (Healthy Individuals) | Blood Collection (Diabetic Patients) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Blood Collection (Healthy Individuals) | Blood Collection (Diabetic Patients) | Total |
|---|---|---|---|
| Israel | 200 | 10 | 210 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2017 to primary completion in Oct 2017, 0 months.
Results were first posted in Mar 2019, 1 year 4 months after primary completion.
Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 159. This study's 0 months is below that.
Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Tirat Carmel Mental Health Center