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

Conditions
Diabetes Mellitus 2 Type
Registration Number
NCT01627509
Lead Sponsor
Sheba Medical Center
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
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

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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
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Sheba Medical Center

🇮🇱

Tel Hashomer, Israel

The Institute of Endocrinology, Sheba Medical Center

🇮🇱

Tel Hashomer, Gush Dan, Israel

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