Clinical trial NCT01237301: Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes
Official title: Comparison of Clinical Decisions and Outcomes Employing a Treat to Target Design for Subjects With Type 2 Diabetes Randomized to Either SMBG or CGM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Continuous Glucose Monitoring
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
name: International Diabetes Center at Park Nicollet
First posted: 2010-11-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Change in Hemoglobin A1c
timeFrame: 2 week baseline to 16 week final
Secondary outcomes:
measure: Glucose Exposure (Area Under the Diurnal Median Curve)
timeFrame: 16 weeks
measure: Percent of Time in Hypoglycemia Range
timeFrame: 16 weeks
measure: Change From Baseline in CGM Glucose Variability
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Richard M. Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazze RS, Strock E, Wesley D, Borgman S, Morgan B, Bergenstal R, Cuddihy R. Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis. Diabetes Technol Ther. 2008 Jun;10(3):149-59. doi: 10.1089/dia.2007.0293.