NCT00202033

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 3, 2015

Status Verified

April 1, 2013

Enrollment Period

4.7 years

First QC Date

September 12, 2005

Last Update Submit

December 2, 2015

Conditions

Type 2 Diabetes

Keywords

referred tocomprehensivediabeteseducationprogram

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    2 years

Secondary Outcomes (1)

  • blood glucose testing frequency

    2 years

Study Arms (3)

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

Interventions

frequency of self monitoring blood glucoseBEHAVIORAL

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

123

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Insulin therapy
  • Unable/unwilling to perform SMBG
  • Participating in another research study
  • Currently performing SMBG \>3 times/week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Richard M Bergenstal, MD

    Park Nicollet Institute/International Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 3, 2015

Record last verified: 2013-04

Locations

US(1)