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
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Device: CGM Group Device: SMBG Group||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Percentage Change in Hemoglobin A1c [ Time Frame: 2 week baseline to 16 week final ]
- 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.
- 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.
- 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).
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
|United States, Minnesota|
|International Diabetes Center|
|Minneapolis, Minnesota, United States, 55416|
|Principal Investigator:||Richard M. Bergenstal, MD||International Diabetes Center at Park Nicollet|