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Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring 91

Completed
Clinical Trial NCT01072565 was an interventional study for Type 2 Diabetes that is now completed. The study started on February 1, 2010, with plans to enroll 91 participants. Led by HealthPartners Institute, the expected completion date was January 1, 2012. The latest data from ClinicalTrials.gov was last updated on November 26, 2015.
Brief Summary
The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.
Official Title

Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)

Conditions
Type 2 Diabetes
Other Study IDs
  • 03914-09-C
NCT ID Number
NCT01072565
Start Date (Actual)
2010-02
Last Update Posted
2015-11-26
Completion Date (Estimated)
2012-01
Enrollment (Estimated)
91
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Type 2 Diabetes
A1c
Continuous Glucose Monitoring
Blood Glucose
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Factorial
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorSMBG Only
You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be blinded (neither you nor the study doctor will be able to see the CGM measurements until your final study visit). Only your SMBG measurements will be considered to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and...Show More
SMBG to guide clinical decisions
The investigator will base clinical decisions on A1c and modal day analysis of SMBG.
Active ComparatorSMBG and CGM
You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be downloaded at each study visit and will be considered along with your SMBG measurements to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of 7%.
SMBG and CGM
The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.
Three, six and nine months.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Determine the incremental benefit of CGM for clinical decision-making.
Three, six and nine months.
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Male or female subjects ≥18 and ≤75 years of age
  • Clinical diagnosis of diabetes
  • Diabetes duration ≥ 1 year
  • HbA1c ≥7.2%
  • Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy

  • Taken 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
  • Unable to follow the study protocol
  • Unable to speak, read and write in English
HealthPartners Institute logoHealthPartners Institute
No contact data.
1 Study Locations in 1 Countries

Minnesota

International Diabetes Center, Minneapolis, Minnesota, 55416, United States