Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- HealthPartners Institute
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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%.
Intervention: SMBG to guide clinical decisions (Other)
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%.
Intervention: SMBG and CGM (Other)
Outcomes
Primary Outcomes
Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.
Time Frame: Three, six and nine months.
Secondary Outcomes
- Determine the incremental benefit of CGM for clinical decision-making.(Three, six and nine months.)