CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target

Diabetes Care Center1 site in 1 country20 target enrollmentFebruary 2012

ConditionsType 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Diabetes Care Center
Enrollment: 20
Locations: 1
Primary Endpoint: Percentage of time CGM glucose is <70mg/dl
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose.

Detailed Description

In many clinical trials, basal insulin is titrated to only a fasting glucose goal. The usual final dose is \>0.4U/kg. In carefully CGM monitored/titrated studies in both basal insulin alone or in pump-treated T2DM, we have found the basal insulin dose to be \<0.3U/kg. This suggests that if guided by a single daily fasting glucose, titration may result in an excessive basal dose. This study will examine that issue.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

December 2012

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Diabetes Care Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 2 diabetes
•Age 18 years and above
•Concurrently on +/-thiazolidnedione +/-DDP IV inhibitors +/-metformin +/- glinides and basal insulin analogs
•A1C 10% or below
•Capable of self monitoring glucose at least 4 x a day
•Previously compliant with clinical recommendations
•Fasting blood glucose \<110mg/dl average for 3 consecutive days
•BMI \<45 kg/m

Exclusion Criteria

•Urinary ketosis
•Current or expected alternation in insulin sensitivity such as major surgery, infection, renal failure, glucocorticoid treatment, recent serious hypoglycaemic episode
•Currently participating in another clinical trial
•Using rapid insulin insulin
•Pregnancy or nursing or the intention of becoming pregnant or not using adequate birth control
•Significant liver or heart failure.

Outcomes

Primary Outcomes

Percentage of time CGM glucose is <70mg/dl

Time Frame: the subject will be followed for 9 days

The percentage of time CGM glucose is \<70 mg/dl during the basal glucose evaluation

Secondary Outcomes

Percentage of time CGM glucose is <40 mg/dl(the subject will be followed for 9 days)
Determined hypoglycaemic episodes(the subject will be followed for 9 days)
Weight gain(the subject will be followed for 9 days)