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

NCT ID: NCT01548222

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Keywords

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type 2 diabetes continuous glucose basal insulin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Diabetes Care Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Diabetes Care Center

Salinas, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19515182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17924873 (View on PubMed)

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.

Reference Type RESULT
PMID: 19885117 (View on PubMed)

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.

Reference Type RESULT
PMID: 19120433 (View on PubMed)

Other Identifiers

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MM2012

Identifier Type: -

Identifier Source: org_study_id