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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Maccabi Healthcare Services, Israel
ClinicalTrials.gov Identifier:
NCT01779115
First received: January 28, 2013
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition
Type 1 Diabetes
Type 2 Diabetes

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Target Follow-Up Duration: 1 Month
Official Title: Computerized Registry of Diabetes Patients in a Large Health Maintenance Organization in Israel

Resource links provided by NLM:


Further study details as provided by Maccabi Healthcare Services, Israel:

Primary Outcome Measures:
  • Prevalence rates of Diabetes [ Time Frame: Up to 100 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of performance of eye examinations,blood and urine tests [ Time Frame: up to 100 years ] [ Designated as safety issue: No ]
  • Number and types of Drugs purchased [ Time Frame: 100 years ] [ Designated as safety issue: No ]
  • Number of visits to physician offices [ Time Frame: up to 100 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 126000
Study Start Date: January 1998
Estimated Primary Completion Date: December 2100 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetes patients.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779115

Locations
Israel
Maccabi Healthcare Services
Tel Aviv, Israel, 68125
Sponsors and Collaborators
Maccabi Healthcare Services, Israel
Investigators
Study Director: Gabriel Chodick, PHD Head,Epidemiology & Database Reseaech Unit, Medical Division, Maccabi H.S
  More Information

Additional Information:
Publications:
Responsible Party: Maccabi Healthcare Services, Israel
ClinicalTrials.gov Identifier: NCT01779115     History of Changes
Other Study ID Numbers: MACCVREGDIAB
Study First Received: January 28, 2013
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Maccabi Healthcare Services, Israel:
Registry,Diabetes,Health Maintenance Organization

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014