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

Type 2 Diabetes Clinical Trial

Official title:

Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072565
• Other study ID #: 03914-09-C
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: November 25, 2015
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: April 2013
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• SMBG to guide clinical decisions
The investigator will base clinical decisions on A1c and modal day analysis of SMBG.
• SMBG and CGM
The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.

Locations

Country	Name	City	State
United States	International Diabetes Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	Abbott Diabetes Care, International Diabetes Center at Park Nicollet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.		Three, six and nine months.	No
Secondary	Determine the incremental benefit of CGM for clinical decision-making.		Three, six and nine months.	No