Comparison of Two Insulin Regimens in Optimally-controlled Patients With DM2.
NCT ID: NCT01627509
Last Updated: 2012-06-25
Study Results
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Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2012-05-31
2013-08-31
Brief Summary
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* as Basal/bolus therapy (B/B) in four-five injections per day .
* as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is achieved, the more likely patient would suffer from hypoglycemic episodes. We propose that the probability of hypoglycemia and its severity has no difference in two main insulin therapy schemes mentioned above.
The objective of the study is to compare the incidence of hypoglycemia and its severity in well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens, through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style Navigator).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Diabetes Mellitus Type 2 history of one year at least.
* HAb1C \< 7% and less
* Age 18-80 yrs
* Normal Liver function tests
Exclusion Criteria
* Pregnancy or breastfeeding mothers
* Abnormal liver or kidney functional tests
* Type 1 Diabetes or LADA
* any active disease ( like viral) at the period of investigation
18 Years
80 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Locations
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The Institute of Endocrinology, Sheba Medical Center
Tel Litwinsky, Gush Dan, Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHEBA-10-7894-JI-CTIL
Identifier Type: -
Identifier Source: org_study_id
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