Type 1 DiabetesNCT01779115
Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Maccabi Healthcare Services, Israel at 1 site in Israel.
Trial summary
A computerized registry of diabetes patients in a large health maintenance organization in Israel. The registry is aimed to be used by health professionals to identify diabetes patients and to follow the courses of their illnesses and risk factors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- How many people
- 126,000 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 1998to Dec 2100
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetes patients.
Who may be able to join
- Diabetic patient was defined according to the criteria suggested by American Diabetes Association - symptoms diagnosed as diabetes and fasting plasma glucose >125 mg/dl (7.0 lmol/l) or casual (namely, any time of day without regard to time since last meal) plasma glucose concentration P200 mg/dl. In order to reach maximal validity, we also included any patient who answered to one of the following: (1) purchased at least two hypoglycemic medications or single insulin dose during 6 months. (2) Had HbA1c result of at least 7.25%. HbA1c of 6.5% was used as entry criterion to registry only when the patient was diagnosed as diabetic.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Computerized Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel
A computerized registry of diabetes patients in a large health maintenance organization in Israel. The registry is aimed to be used by health professionals to identify diabetes patients and to follow the courses of their illnesses and risk factors.
Read the detailed description
The registry was initiated in 1998 by Maccabi Healthcare services, which is the second largest publicly funded HMO in Israel,serving 24% of the total population with a nationwide distribution.
The registry uses advanced information technology that integrates personal computerized community and hospital records, data from laboratory tests, dispensed medications, physiological signals, radiological images, and reports from investigations and procedures.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Registry,Diabetes,Health Maintenance Organization
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence rates of Diabetes
Measured: Up to 100 years
Secondary outcomes (3)
Rates of performance of eye examinations,blood and urine tests
Measured: up to 100 years
Number and types of Drugs purchased
Measured: 100 years
Number of visits to physician offices
Measured: up to 100 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 1998
- Primary completionDec 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Case only
- Enrolment
- 126,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Maccabi Healthcare Services, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Chodick, PHD, Study director, Head,Epidemiology & Database Reseaech Unit, Medical Division, Maccabi H.S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779115
- Sponsor's protocol ID
- MACCVREGDIAB
- Status last verified
- Jan 2013
- First submitted
- 28 Jan 2013
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chodick G, Heymann AD, Shalev V, Kookia E. The epidemiology of diabetes in a large Israeli HMO. Eur J Epidemiol. 2003;18(12):1143-6. doi: 10.1023/b:ejep.0000006635.36802.c8.
PubMed 14758871Heymann AD, Chodick G, Halkin H, Karasik A, Shalev V, Shemer J, Kokia E. The implementation of managed care for diabetes using medical informatics in a large Preferred Provider Organization. Diabetes Res Clin Pract. 2006 Mar;71(3):290-8. doi: 10.1016/j.diabres.2005.07.002. Epub 2005 Aug 19.
PubMed 16112245
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel
- ClinicalTrials.gov ID
- NCT01779115
- Acronym / sponsor ID
- MACCVREGDIAB
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Registry,Diabetes,Health Maintenance Organization
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 126,000 participants (estimated)
- Lead sponsor
- Maccabi Healthcare Services, IsraelUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Dec 2100 (estimated)
- First posted
- 30 Jan 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.
A computerized registry of diabetes patients in a large health maintenance organization in Israel. The registry is aimed to be used by health professionals to identify diabetes patients and to follow the courses of their illnesses and risk factors.
Detailed description
The registry was initiated in 1998 by Maccabi Healthcare services, which is the second largest publicly funded HMO in Israel,serving 24% of the total population with a nationwide distribution.
The registry uses advanced information technology that integrates personal computerized community and hospital records, data from laboratory tests, dispensed medications, physiological signals, radiological images, and reports from investigations and procedures.
Study design
- Observational model
- Case only
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetes patients.
Key inclusion criteria (1 listed)
- Diabetic patient was defined according to the criteria suggested by American Diabetes Association - symptoms diagnosed as diabetes and fasting plasma glucose >125 mg/dl (7.0 lmol/l) or casual (namely, any time of day without regard to time since last meal) plasma glucose concentration P200 mg/dl. In order to reach maximal validity, we also included any patient who answered to one of the following: (1) purchased at least two hypoglycemic medications or single insulin dose during 6 months. (2) Had HbA1c result of at least 7.25%. HbA1c of 6.5% was used as entry criterion to registry only when the patient was diagnosed as diabetic.
Key exclusion criteria (0 listed)
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
Prevalence rates of Diabetes
Time frame: Up to 100 years
3 secondary outcomes
Rates of performance of eye examinations,blood and urine tests
Time frame: up to 100 years
Number and types of Drugs purchased
Time frame: 100 years
Number of visits to physician offices
Time frame: up to 100 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Results publication: PubMed 14758871Chodick G, Heymann AD, Shalev V, Kookia E. The epidemiology of diabetes in a large Israeli HMO. Eur J Epidemiol. 2003;18(12):1143-6. doi: 10.1023/b:ejep.0000006635.36802.c8.
- Results publication: PubMed 16112245Heymann AD, Chodick G, Halkin H, Karasik A, Shalev V, Shemer J, Kokia E. The implementation of managed care for diabetes using medical informatics in a large Preferred Provider Organization. Diabetes Res Clin Pract. 2006 Mar;71(3):290-8. doi: 10.1016/j.diabres.2005.07.002. Epub 2005 Aug 19.
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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.
Gabriel Chodick, PHD study director
Head,Epidemiology & Database Reseaech Unit, Medical Division, Maccabi H.S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Maccabi Healthcare Services, Israel at 1 site 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 1 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 31 Jan 2013. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence rates of Diabetes (time frame: Up to 100 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779115, which also lists 2 linked publications.
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 31 Jan 2013.