ClinicalTrials.gg
CompletedNCT00202033Updated Dec 3, 2015

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

A Phase 4 interventional study of frequency of self monitoring blood glucose in Type 2 Diabetes, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by HealthPartners Institute · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • referred to
  • comprehensive
  • diabetes
  • education
  • program
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 150 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

HealthPartners Institute is the lead sponsor of 166 studies on the registry; 20 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Insulin therapy
  • Unable/unwilling to perform SMBG
  • Participating in another research study
  • Currently performing SMBG >3 times/week
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    1

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

    Behavioral: frequency of self monitoring blood glucose

  • Experimental
    2

    only self monitor blood glucose when fasting

    Behavioral: frequency of self monitoring blood glucose

  • Experimental
    3

    no self monitoring of blood glucose

    Behavioral: frequency of self monitoring blood glucose

Interventions

  • Behavioralfrequency of self monitoring blood glucose

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

06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: 2 years

Secondary outcomes

  1. blood glucose testing frequency

    Time frame: 2 years

07

Study locations

1 site
  • International Diabetes Center
    Minneapolis, Minnesota 55416, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2004, a primary completion of May 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 20, 2005
Start
Sep 2004
Primary completionActual
May 2009
CompletionActual
May 2009
Last update
Dec 3, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00202033
Collaborators
International Diabetes Center at Park Nicollet, LifeScan
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Sep 2004
Primary completion
May 2009
Completion
May 2009
Last update
Dec 3, 2015

Study contacts

Richard M Bergenstal, MD
principal investigator · Park Nicollet Institute/International Diabetes Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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