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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01627509

Enrollment

Registered

2012-06-25

Start date

2012-05-31

Completion date

2013-08-31

Last updated

2012-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus 2 Type

Keywords

continuous glucose monitoring system, hypoglycemia, insulin regimen, basal bolus therapy, modern premixed insulin, diabetes control

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion 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

Countries

Israel

Contacts

Primary ContactJacob Ilani, Dr.

Jacob.Ilany2@sheba.health.gov.il+97235303103

Backup ContactShmuel Levit, Dr.

Shlevit@gmail.com+972508805375

Outcome results