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
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