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
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
The Institute of Endocrinology, Sheba Medical Center
🇮🇱Tel Hashomer, Gush Dan, Israel