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 |
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.
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).
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
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