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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: SMBG to guide clinical decisions; Other: SMBG and CGM

• Registration Number: NCT01072565
• Lead Sponsor: HealthPartners Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-04
• Last Update Submitted: 2015-11-25
• Last Update Posted: 2015-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
SMBG Only	SMBG to guide clinical decisions	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%.
SMBG and CGM	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%.

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.	Three, six and nine months.

Secondary Outcome Measures

Name	Time	Method
Determine the incremental benefit of CGM for clinical decision-making.	Three, six and nine months.

Trial Locations

Locations (1)

International Diabetes Center; 🇺🇸 Minneapolis, Minnesota, United States