Comparison of Two Insulin Regimens in Optimally-controlled Patients With DM2.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01627509|
Recruitment Status : Unknown
Verified June 2012 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : June 25, 2012
Last Update Posted : June 25, 2012
Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways :
- 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).
|Condition or disease|
|Diabetes Mellitus 2 Type|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Comparison of Modern Premixed Insulin and Basal-Bolus Regimens on Blood Glucose Control Using CGMS Device in Optimally-controlled Subjects With DM2.|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||August 2013|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627509
|Contact: Jacob Ilani, Dr.||+97235303103||Jacob.Ilany2@sheba.health.gov.il|
|Contact: Shmuel Levit, Dr.||+972508805375||Shlevit@gmail.com|
|The Institute of Endocrinology, Sheba Medical Center||Not yet recruiting|
|Tel Hashomer, Gush Dan, Israel, 52621|
|Contact: Jacob Ilani, DR. +97235303103 Jacob.Ilany2@sheba.health.gov.il|
|Contact: Shmuel Levit, DR. +972508805375 email@example.com|
|Principal Investigator: Jacob Ilani, DR.|
|Sub-Investigator: Shmuel Levit, DR.|
|Sheba Medical Center||Recruiting|
|Tel Hashomer, Israel, 52621|