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

Sheba Medical Center

Status: Unknown

Conditions: Diabetes Mellitus 2 Type

Study type: Observational

Funder types: Other

Identifiers

NCT01627509

SHEBA-10-7894-JI-CTIL

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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