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

Sponsors and Collaborators:	Park Nicollet Institute International Diabetes Center LifeScan
Information provided by:	Park Nicollet Institute
ClinicalTrials.gov Identifier:	NCT00202033

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 Referred to Comprehensive Diabetes Education Program	Behavioral: frequency of self monitoring blood glucose	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes

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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental self monitor blood glucose 3 times a day per usual diabetes class curriculum	Behavioral: frequency of self monitoring blood glucose
2: Experimental only self monitor blood glucose when fasting	Behavioral: frequency of self monitoring blood glucose
3: Experimental no self monitoring of blood glucose	Behavioral: frequency of self monitoring blood glucose

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

LifeScan

Investigators

Principal Investigator:

Richard M Bergenstal, MD

Park Nicollet Institute/International Diabetes Center

More Information

Responsible Party:	International Diabetes Center ( Richard M. Bergenstal, MD )
Study ID Numbers:	01856-04-C
Study First Received:	September 12, 2005
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00202033
Health Authority:	United States: Park Nicollet Institute Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009