Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:10/19/2018
Start Date:October 2010
End Date:March 2012

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Comparison of Clinical Decisions and Outcomes Employing a Treat to Target Design for Subjects With Type 2 Diabetes Randomized to Either SMBG or CGM

The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions
related to the management of type 2 diabetes. The secondary objective is to determine the
benefit of using CGM for clinical diabetes management decision-making.

This study involves the use of the following 2 glucose monitoring methods to measure your
blood sugar (glucose) levels and help manage type 2 diabetes:

1. Self Monitoring Blood Glucose (SMBG): blood glucose is measured 4-7 times each day using
finger sticks and an blood glucose meter.

2. Continuous Glucose Monitoring (CGM): blood glucose is measured continuously via the CGM
device. This device has been approved for use by the U.S. Food and Drug Administration
(FDA).

Inclusion Criteria:

- Male or female ≥18 and ≤75 years of age (Upper range to assure dexterity for use of
CGM)

- Clinical diagnosis of type 2 diabetes

- HbA1c ≥7.0%

- Diabetes can be treated with any of the following therapies within one month prior to
study enrollment: (1) medical nutrition therapy alone or with metformin; (2)
sulfonylurea with or without metformin; (3) dipeptidyl peptidase 4 (DPP-4) inhibitor
or Glucagon-like peptide-1 (GLP-1) agonist with or without metformin; or insulin with
or without metformin.

Exclusion Criteria:

- Treated with Thiazolidinediones (TZD)

- Administered prednisone or cortisone medications in the previous 30 days

- Currently pregnant or planning pregnancy during the study period

- Presence of any severe medical or psychological condition or chronic
conditions/infections that in the opinion of the Investigator would compromise the
subject's safety or successful participation in the study

- HbA1c <7.0%

- Unable to follow the study protocol

- Unable to speak, read and write in English
We found this trial at
1
site
Minneapolis, Minnesota 55416
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Minneapolis, MN
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