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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2012

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Diabetes Care Center
  • Collaborator
    • Medtronic
  • Provider of Information About this Clinical Study
    • Sponsor

References

Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets – the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.

Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes–results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007 Nov;9(6):902-13. doi: 10.1111/j.1463-1326.2007.00804.x.

Citations Reporting on Results

Strange P. Treat-to-target insulin titration algorithms when initiating long or intermediate acting insulin in type 2 diabetes. J Diabetes Sci Technol. 2007 Jul;1(4):540-8. doi: 10.1177/193229680700100412.

King AB. Once-daily insulin detemir is comparable to once-daily insulin glargine in providing glycaemic control over 24 h in patients with type 2 diabetes: a double-blind, randomized, crossover study. Diabetes Obes Metab. 2009 Jan;11(1):69-71. doi: 10.1111/j.1463-1326.2008.01014.x.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.