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

NCT ID: NCT00202033

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

frequency of self monitoring blood glucose

Intervention Type BEHAVIORAL

Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.

2

only self monitor blood glucose when fasting

Group Type EXPERIMENTAL

frequency of self monitoring blood glucose

Intervention Type BEHAVIORAL

Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.

3

no self monitoring of blood glucose

Group Type EXPERIMENTAL

frequency of self monitoring blood glucose

Intervention Type BEHAVIORAL

Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

frequency of self monitoring blood glucose

Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Diabetes Center at Park Nicollet

OTHER

Sponsor Role collaborator

LifeScan

INDUSTRY

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard M Bergenstal, MD

Role: PRINCIPAL_INVESTIGATOR

Park Nicollet Institute/International Diabetes Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

International Diabetes Center

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01856-04-C

Identifier Type: -

Identifier Source: org_study_id