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Completed

NCT Number: NCT01237301

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

About this study

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:

  • Self Monitoring Blood Glucose (SMBG): blood glucose is measured 4-7 times each day using finger sticks and an blood glucose meter.
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CGM Group

Device

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

SMBG group

Device

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 outcomes

  1. Percentage Change in Hemoglobin A1c

    Time frame: 2 week baseline to 16 week final

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • International Diabetes Center at Park Nicollet
  • Roche Diagnostics GmbH

Registry information

Official study 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

Acronym: REACT3

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2010
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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