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

This study is currently recruiting participants.
Verified June 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01627509
First received: June 21, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 21, 2012
June 21, 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).

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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.
 
Recruiting
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
Both
18 Years to 80 Years
No
Contact: Jacob Ilani, Dr. +97235303103 Jacob.Ilany2@sheba.health.gov.il
Contact: Shmuel Levit, Dr. +972508805375 Shlevit@gmail.com
Israel
 
NCT01627509
SHEBA-10-7894-JI-CTIL
No
Sheba Medical Center
Sheba Medical Center
Not Provided
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Sheba Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP