NCT01627509

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetes Mellitus 2 Type

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-05-01
• Completion: 2013-08-01
• First posted: 2012-06-25
• Last updated: 2012-06-25

Locations

2 sites across 1 country: Israel