Clinical trial NCT01779115: Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel
Official title: Computerized Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Registry,Diabetes,Health Maintenance Organization
Lead sponsor: Maccabi Healthcare Services, Israel
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 126000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes patients.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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.

Primary outcomes:
measure: Prevalence rates of Diabetes
timeFrame: Up to 100 years
Secondary outcomes:
measure: Rates of performance of eye examinations,blood and urine tests
timeFrame: up to 100 years
measure: Number and types of Drugs purchased
timeFrame: 100 years
measure: Number of visits to physician offices
timeFrame: up to 100 years
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Maccabi Healthcare Services
Study officials:
affiliation: Head,Epidemiology & Database Reseaech Unit, Medical Division, Maccabi H.S
name: Gabriel Chodick, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Heymann 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.