Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (REACT3)

This study has been completed.
Sponsor:
Collaborators:
Roche Diagnostics Corporation
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01237301
First received: November 2, 2010
Last updated: November 14, 2013
Last verified: November 2013

November 2, 2010
November 14, 2013
October 2010
March 2012   (final data collection date for primary outcome measure)
Percentage Change in Hemoglobin A1c [ Time Frame: 2 week baseline to 18 week final ] [ Designated as safety issue: No ]
The primary objective of this study is to evaluate the utilization of SMBG and CGM for clinical decisions related to the management of type 2 diabetes. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Outcome will be measured by:

i. HbA1c ii. Glucose exposure (area under the diurnal median curve) iii. Glucose variability (inter-quartile range) iv. Glucose stability (hourly change in the median curve) v. Incidence of hypoglycemia (degree, duration, frequency)

Complete list of historical versions of study NCT01237301 on ClinicalTrials.gov Archive Site
The Secondary Objective is to Determine the Incremental Benefit of CGM for Clinical Decision-making. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Outcome will be measured by:

i. HbA1c ii. Glucose exposure (area under the diurnal median curve) iii. Glucose variability (inter-quartile range) iv. Glucose stability (hourly change in the median curve) v. Incidence of hypoglycemia (degree, duration, frequency)

Same as current
Not Provided
Not Provided
 
Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes
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 AccuChek Aviva blood glucose meter.
  2. Continuous Glucose Monitoring (CGM): blood glucose is measured continuously via the DexCom SevenPlus CGM device. This device has been approved for use by the U.S. Food and Drug Administration (FDA).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
Device: Continuous Glucose Monitoring (CGM)
Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
Other Names:
  • DexCom SevenPlus CGM
  • AccuChek Aviva blood glucose meter
  • Active Comparator: CGM Group
    Wear an unblinded CGM for 16 weeks.
    Intervention: Device: Continuous Glucose Monitoring (CGM)
  • Active Comparator: SMBG Group
    Use SMBG 4 to 7 times a day for 16 weeks.
    Intervention: Device: Continuous Glucose Monitoring (CGM)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
March 2012
March 2012   (final data collection date for primary outcome measure)

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) DPP-4 inhibitor or GLP-1 agonist with or without metformin; or insulin with or without metformin.

Exclusion Criteria:

  • Treated with 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01237301
04034-10-C
Yes
Park Nicollet Institute
Park Nicollet Institute
  • Roche Diagnostics Corporation
  • International Diabetes Center at Park Nicollet
Principal Investigator: Roger S. Mazze, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Richard M. Bergenstal, MD International Diabetes Center at Park Nicollet
Park Nicollet Institute
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP