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

HealthPartners Institute

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: SMBG and CGM; Other: SMBG to guide clinical decisions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01072565

03914-09-C

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

SMBG Only

Active Comparator group

Description:

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%.

Treatment:

Other: SMBG to guide clinical decisions

SMBG and CGM

Active Comparator group

Description:

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%.

Treatment:

Other: SMBG and CGM