Diabetes Mellitus 2 Type Clinical Trial
Official title:
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).
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | August 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sheba Medical Center | Tel Hashomer | |
| Israel | The Institute of Endocrinology, Sheba Medical Center | Tel Hashomer | Gush Dan |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center |
Israel,