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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
History of Changes
  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:

Drug Information available for: Dextrose
U.S. FDA Resources

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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013