We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00202033
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 3, 2015
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
LifeScan
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: frequency of self monitoring blood glucose Phase 4

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  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes
Study Start Date : September 2004
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. blood glucose testing frequency [ Time Frame: 2 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202033


Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
International Diabetes Center at Park Nicollet
LifeScan
Investigators
Principal Investigator: Richard M Bergenstal, MD Park Nicollet Institute/International Diabetes Center

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00202033     History of Changes
Other Study ID Numbers: 01856-04-C
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: April 2013

Keywords provided by HealthPartners Institute:
referred to
comprehensive
diabetes
education
program

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