Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes

December 2, 2015 updated by: HealthPartners Institute
To determine if the frequency of blood glucose testing in patients with type 2 diabetes who are being treated with diet and exercise alone or diet and exercise plus oral agents will impact the HbA1c level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine the impact of SMBG frequency on blood glucose control in patients receiving systematic diabetes management education through Type 2 Diabetes BASICS at International Diabetes Center.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Treatment with diet and exercise alone or with the addition of 1 or 2 oral agents
  • Enrolled in Type 2 BASICS program
  • A1c between 7.0 and 11%, inclusive
  • Able to understand spoken English

Exclusion Criteria:

  • Insulin therapy
  • Unable/unwilling to perform SMBG
  • Participating in another research study
  • Currently performing SMBG >3 times/week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
self monitor blood glucose 3 times a day per usual diabetes class curriculum
Behavioral: frequency of self monitoring blood glucose
Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.
Experimental: 2
only self monitor blood glucose when fasting
Behavioral: frequency of self monitoring blood glucose
Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.
Experimental: 3
no self monitoring of blood glucose
Behavioral: frequency of self monitoring blood glucose
Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
blood glucose testing frequency
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

LifeScan
International Diabetes Center at Park Nicollet

Investigators

  • Principal Investigator: Richard M Bergenstal, MD, Park Nicollet Institute/International Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01856-04-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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