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

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT01548222
• Lead Sponsor: Diabetes Care Center

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of time CGM glucose is <70mg/dl	the subject will be followed for 9 days	The percentage of time CGM glucose is \<70 mg/dl during the basal glucose evaluation

Secondary Outcome Measures

Name	Time	Method
Determined hypoglycaemic episodes	the subject will be followed for 9 days	The percentage of subjects who perceived all CGM determined hypoglycaemic episodes
Percentage of time CGM glucose is <40 mg/dl	the subject will be followed for 9 days	The percentage of time the CGM glucose is \<40 mg/dl
Weight gain	the subject will be followed for 9 days	The mean weight gain since initiating basal insulin fromo retrospectively gathered data.

Trial Locations

Locations (1)

Diabetes Care Center; 🇺🇸 Salinas, California, United States