The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes (CGM PreDM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01741467|
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pre-diabetes Impaired Glucose Tolerance||Behavioral: RT-CGM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2016|
Patients using the RT-CGM for the intervention portion of the study.
- Differences in blood glucose [ Time Frame: baseline, 18 months ]Changes in A1c and fasting blood glucose over time and between the intervention and control groups.
- Impact of lifestyle changes [ Time Frame: baseline, 18 months ]Evaluating the impact of lifestyle changes on levels of glycemic control in the control and experimental groups.
- Changes in Glucose dynamics [ Time Frame: baseline, 18 months ]Comparison of intervention and control group on standard measures of glucose dynamics.
- Differences in blood pressure. [ Time Frame: baseline, 18 months ]Objective comparison between the control and experimental group in changes in blood pressure.
- Differences in lipids. [ Time Frame: baseline, 18 months ]Objective comparison between the control group and the experimental group on changes in lipids.
- Differences in weight [ Time Frame: baseline, 18 months ]Objective comparison between the control group and the experimental group on changes in weight.
- Changes in medication use [ Time Frame: baseline, 18 months ]An objective comparison between the control and experimental group on changes in medication use.
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): NCT01741467
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889-5600|
|Principal Investigator:||Robert Vigersky||Walter Reed National Military Medical Center|