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
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Device: Continuous Glucose Monitoring (CGM)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Percentage Change in Hemoglobin A1c [ Time Frame: 2 week baseline to 18 week final ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)



Enrollment: 124
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CGM Group
Wear an unblinded CGM for 16 weeks.
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: SMBG Group
Use SMBG 4 to 7 times a day for 16 weeks.
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

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 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).
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237301

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
Roche Diagnostics Corporation
International Diabetes Center at Park Nicollet
Investigators
Principal Investigator: Roger S. Mazze, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Richard M. Bergenstal, MD International Diabetes Center at Park Nicollet
  More Information

Publications:
Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01237301     History of Changes
Other Study ID Numbers: 04034-10-C
Study First Received: November 2, 2010
Results First Received: August 30, 2013
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
Type 2 Diabetes
Continuous Glucose Monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2014