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

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ClinicalTrials.gov Identifier: NCT01237301
Recruitment Status : Completed
First Posted : November 9, 2010
Results First Posted : January 6, 2014
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Roche Diagnostics
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
HealthPartners Institute

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: CGM Group Device: SMBG Group Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: CGM Group
Wear an unblinded CGM for 16 weeks. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use real time continuous glucose monitoring (rt CGM).
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.
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. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use structured self monitoring blood glucose (stSMBG) and periodic, blinded continuous glucose monitoring (CGM).
Device: 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.
Other Names:
  • AccuChek Aviva blood glucose meter
  • DexCom SevenPlus CGM




Primary Outcome Measures :
  1. Percentage Change in Hemoglobin A1c [ Time Frame: 2 week baseline to 16 week final ]

Secondary Outcome Measures :
  1. Glucose Exposure (Area Under the Diurnal Median Curve) [ Time Frame: 16 weeks ]
    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.

  2. Percent of Time in Hypoglycemia Range [ Time Frame: 16 weeks ]

    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.


  3. Change From Baseline in CGM Glucose Variability [ Time Frame: Baseline and 16 weeks ]
    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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237301


Locations
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United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
Roche Diagnostics
International Diabetes Center at Park Nicollet
Investigators
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Principal Investigator: Richard M. Bergenstal, MD International Diabetes Center at Park Nicollet

Publications:
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT01237301     History of Changes
Other Study ID Numbers: 04034-10-C
First Posted: November 9, 2010    Key Record Dates
Results First Posted: January 6, 2014
Last Update Posted: October 17, 2018
Last Verified: November 2013

Keywords provided by HealthPartners Institute:
Type 2 Diabetes
Continuous Glucose Monitoring

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