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Comparison of Two Insulin Regimens in Optimally-controlled Patients With DM2.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627509
First Posted: June 25, 2012
Last Update Posted: June 25, 2012
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.
Information provided by (Responsible Party):
Sheba Medical Center
June 21, 2012
June 25, 2012
June 25, 2012
May 2012
May 2013   (Final data collection date for primary outcome measure)
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No Changes Posted
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Comparison of Two Insulin Regimens in Optimally-controlled Patients With DM2.
Comparison of Modern Premixed Insulin and Basal-Bolus Regimens on Blood Glucose Control Using CGMS Device in Optimally-controlled Subjects With DM2.

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
40 Subjects with 1 year and more of T2DM history , with two consistent HbA1C values of 7% or less - according to the blood tests within last six months.
Diabetes Mellitus 2 Type
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
August 2013
May 2013   (Final data collection date for primary outcome measure)

Major Inclusion Criteria:

  • Diabetes Mellitus Type 2 diagnosis confirmed by endocrinologist.
  • Diabetes Mellitus Type 2 history of one year at least.
  • HAb1C < 7% and less
  • Age 18-80 yrs
  • Normal Liver function tests

Major Exclusion Criteria:

  • History of substance use
  • 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01627509
SHEBA-10-7894-JI-CTIL
No
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Sheba Medical Center
Sheba Medical Center
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Sheba Medical Center
June 2012