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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548222
• Other study ID #: MM2012
• Status: Completed
• Phase: N/A
• First received: February 27, 2012
• Last updated: August 23, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Diabetes Care Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Diabetes Care Center	Salinas	California

Sponsors (2)

Lead Sponsor	Collaborator
Diabetes Care Center	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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: 10.111 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time CGM glucose is <70mg/dl	The percentage of time CGM glucose is <70 mg/dl during the basal glucose evaluation	the subject will be followed for 9 days	No
Secondary	Percentage of time CGM glucose is <40 mg/dl	The percentage of time the CGM glucose is <40 mg/dl	the subject will be followed for 9 days	No
Secondary	Determined hypoglycaemic episodes	The percentage of subjects who perceived all CGM determined hypoglycaemic episodes	the subject will be followed for 9 days	No
Secondary	Weight gain	The mean weight gain since initiating basal insulin fromo retrospectively gathered data.	the subject will be followed for 9 days	No