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

HealthPartners Institute

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Behavioral: frequency of self monitoring blood glucose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00202033

01856-04-C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

1

Experimental group

Description:

self monitor blood glucose 3 times a day per usual diabetes class curriculum

Treatment:

Behavioral: frequency of self monitoring blood glucose

2

Experimental group

Description:

only self monitor blood glucose when fasting

Treatment:

Behavioral: frequency of self monitoring blood glucose

3

Experimental group

Description:

no self monitoring of blood glucose

Treatment:

Behavioral: frequency of self monitoring blood glucose