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NCT00202033 Clinical Trial

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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00202033
Other study ID # 01856-04-C
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated December 2, 2015
Start date September 2004
Est. completion date May 2009

Study information
Verified date April 2013
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority United States: Park Nicollet Institute Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 79 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States International Diabetes Center Minneapolis Minnesota

Sponsors (3)
Lead Sponsor Collaborator
HealthPartners Institute International Diabetes Center at Park Nicollet, LifeScan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c 2 years Yes
Secondary blood glucose testing frequency 2 years No
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