Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel

Type 2 Diabetes Clinical Trial

Official title:

Computerized Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01779115
• Other study ID #: MACCVREGDIAB
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 28, 2013
• Last updated: January 30, 2013
• Start date: January 1998

Study information

• Verified date: January 2013
• Source: Maccabi Healthcare Services, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 126000
• Est. primary completion date: December 2100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Locations

Country	Name	City	State
Israel	Maccabi Healthcare Services	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Maccabi Healthcare Services, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View 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. Epub 2005 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence rates of Diabetes		Up to 100 years	No
Secondary	Rates of performance of eye examinations,blood and urine tests		up to 100 years	No
Secondary	Number and types of Drugs purchased		100 years	No
Secondary	Number of visits to physician offices		up to 100 years	No

External Links

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