Type 1 or 2 DiabeticsNCT01978990
Assessment of a Health Informatics System on Insulin-treated Diabetic Patients
An observational study of Type 1 or 2 Diabetics, run by Hadassah Medical Organization.
Trial summary
Modern medicine provides many solutions that are intended to help control the patient's blood glucose level: insulin and other medications to lower it, glucose tablets or glucagone to raise it when it gets dangerously low, glucometers to quickly measure the blood glucose level, pumps and pens to inject insulin or… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 1 or 2 Diabetics
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Oct 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 1 or 2 diabetics diagnosed at least 12 months prior to study enrollment
Who may be able to join
- Type 1 or 2 diabetics diagnosed at least 12 months prior to study enrollment.
- Treated with insulin (basal only or basal + bolus) for at least 6 months prior to study enroment.
- HbA1c lower than 12% With or without other anti-diabetic drugs.
- 18-80 years of age.
- Male or female.
- Own an Android phone.
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- Able to handle mobile applications, technology-friendly
- Able and willing to understand and comply with the study procedures.
- Provide signed written and informed consent form prior to enrolment in the study.
Who cannot join
- Using an insulin pump.
- Pregnant or planning to be pregnant within the period of the study.
- Active substance abuse.
- Psychosis or schizophrenia under active care.
- Uncorrected severe hearing or visual impairment.
- Any other condition that is not acceptable to the investigator.
About this study
Modern medicine provides many solutions that are intended to help control the patient's blood glucose level: insulin and other medications to lower it, glucose tablets or glucagone to raise it when it gets dangerously low, glucometers to quickly measure the blood glucose level, pumps and pens to inject insulin or other injectable medicine, etc.The objective of this trial is proving the concept and the feasibility of using a medical informatics system comprised of computer hardware, software and a smartphone application to achieve better outcomes.
- Conditions
- Type 1 or 2 Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Management System , blood glucose | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommendation accuracy
Recommendation accuracy: over 80% correspondence between the corrective actions recommended by the system and the corrective actions decided upon by the physician.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startJan 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: financial issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 or 2 DiabeticsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978990
- Sponsor's protocol ID
- 0406-13- HMO-CTIL
- Status last verified
- Mar 2017
- First submitted
- 3 Nov 2013
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Health Informatics System on Insulin-treated Diabetic Patients
- ClinicalTrials.gov ID
- NCT01978990
- Acronym / sponsor ID
- 0406-13- HMO-CTIL
- Conditions
- Type 1 or 2 Diabetics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: financial issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 8 Nov 2013 (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.
Modern medicine provides many solutions that are intended to help control the patient's blood glucose level: insulin and other medications to lower it, glucose tablets or glucagone to raise it when it gets dangerously low, glucometers to quickly measure the blood glucose level, pumps and pens to inject insulin or other injectable medicine, etc.The objective of this trial is proving the concept and the feasibility of using a medical informatics system comprised of computer hardware, software and a smartphone application to achieve better outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Management System , blood glucose | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 or 2 diabetics diagnosed at least 12 months prior to study enrollment
Key inclusion criteria (9 listed)
- Type 1 or 2 diabetics diagnosed at least 12 months prior to study enrollment.
- Treated with insulin (basal only or basal + bolus) for at least 6 months prior to study enroment.
- HbA1c lower than 12% With or without other anti-diabetic drugs.
- 18-80 years of age.
- Male or female.
Key exclusion criteria (6 listed)
- Using an insulin pump.
- Pregnant or planning to be pregnant within the period of the study.
- Active substance abuse.
- Psychosis or schizophrenia under active care.
- Uncorrected severe hearing or visual impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recommendation accuracy
Time frame: three months
Recommendation accuracy: over 80% correspondence between the corrective actions recommended by the system and the corrective actions decided upon by the physician.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 or 2 Diabetics, run by Hadassah Medical Organization.
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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Recommendation accuracy (time frame: three months). 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 9 Mar 2018.