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

Diabetes Care Center

Status: Completed

Conditions: Type 2 Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT01548222

MM2012

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.