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

NCT01548222 | Completed

• 1 other identifier: MM2012
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; continuous glucose; basal insulin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the Diabetes Care Center clinic

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diabetes Care Center: lead
• Medtronic: collaborator

Study Sites (1)

Diabetes Care Center

Salinas, California, 93901, United States

Location

Related 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.

  PMID: 19515182 BACKGROUND

• 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.

  PMID: 17924873 BACKGROUND

• 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.

  PMID: 19885117 RESULT

• 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.

  PMID: 19120433 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 8, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

US (1)