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

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
LifeScan
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00202033
First received: September 12, 2005
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Type 2 Diabetes
Behavioral: frequency of self monitoring blood glucose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • blood glucose testing frequency [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: September 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
  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: NCT00202033

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

No publications provided

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT00202033     History of Changes
Other Study ID Numbers: 01856-04-C
Study First Received: September 12, 2005
Last Updated: April 12, 2013
Health Authority: United States: Park Nicollet Institute Institutional Review Board

Keywords provided by Park Nicollet Institute:
referred to
comprehensive
diabetes
education
program

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

ClinicalTrials.gov processed this record on October 30, 2014