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

H

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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