- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01072565
Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring
November 25, 2015 updated by: HealthPartners Institute
Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55416
- International Diabetes Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SMBG 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/or glucose readings with a goal to achieve an HbA1c level of less than 7%.
|
The investigator will base clinical decisions on A1c and modal day analysis of SMBG.
|
Active Comparator: SMBG 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%.
|
The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.
Time Frame: Three, six and nine months.
|
Three, six and nine months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the incremental benefit of CGM for clinical decision-making.
Time Frame: Three, six and nine months.
|
Three, six and nine months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roger S Mazze, PhD, International Diabetes Center at Park Nicollet
- Principal Investigator: Elinor S Strock, APRN, BC, International Diabetes Center at Park Nicollet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
February 18, 2010
First Submitted That Met QC Criteria
February 19, 2010
First Posted (Estimate)
February 22, 2010
Study Record Updates
Last Update Posted (Estimate)
November 26, 2015
Last Update Submitted That Met QC Criteria
November 25, 2015
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03914-09-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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