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

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Abbott Diabetes Care
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01072565
First received: February 18, 2010
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Other: SMBG to guide clinical decisions
Other: SMBG and CGM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes. [ Time Frame: Three, six and nine months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the incremental benefit of CGM for clinical decision-making. [ Time Frame: Three, six and nine months. ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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%.
Other: SMBG to guide clinical decisions
The investigator will base clinical decisions on A1c and modal day analysis of SMBG.
Active Comparator: 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%.
Other: SMBG and CGM
The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072565

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
International Diabetes Center at Park Nicollet
Abbott Diabetes Care
Investigators
Principal Investigator: Roger S Mazze, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Elinor S Strock, APRN, BC International Diabetes Center at Park Nicollet
  More Information

No publications provided

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01072565     History of Changes
Other Study ID Numbers: 03914-09-C
Study First Received: February 18, 2010
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
Type 2 Diabetes
A1c
Continuous Glucose Monitoring
Blood Glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014