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

Type 2 Diabetes Clinical Trial

— REACT3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237301
• Other study ID #: 04034-10-C
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2013
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• CGM Group
Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
• SMBG Group
Fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes. Used CGM blinded once every four weeks.

Locations

Country	Name	City	State
United States	International Diabetes Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	International Diabetes Center at Park Nicollet, Roche Diagnostics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Hemoglobin A1c		2 week baseline to 16 week final
Secondary	Glucose Exposure (Area Under the Diurnal Median Curve)	The secondary objective is to determine the incremental benefit of CGM for clinical decision-making by using (area under the diurnal median curve). Data was collected to create the curve at every hour of modal day. Example: hours 1-24 of each day. Modal day reflects 14 days worth of CGM data aggregated into a single 24 hour day graph.	16 weeks
Secondary	Percent of Time in Hypoglycemia Range	The secondary objective is to determine the incremental benefit of CGM for clinical decision-making using percent time in hypoglycemia range (< 50 mg/dL). Numerator: amount of time with a value of 49 mg/dL or less. Denominator: total amount of time of CGM measurement.; CGM used for this study produced measurements once every 15 minutes or 360 times per day.	16 weeks
Secondary	Change From Baseline in CGM Glucose Variability	Glucose Variability - Interquartile Range used to determine incremental benefit of CGM for clinical decision making. IQR results reflect the change delta from baseline to 16 weeks. IQR is calculated for each subject at each visit. The change in IQR was calculated as final IQR minus baseline IQR. This measure represents an average of the individual subjects IQR delta (baseline to 16 weeks/final).	Baseline and 16 weeks