Skip to main content
OpenTrials
Completed

NCT Number: NCT01072565

Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring

The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects ≥18 and ≤75 years of age
  • Clinical diagnosis of diabetes
  • Diabetes duration ≥ 1 year
  • HbA1c ≥7.2%
  • Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy

Exclusion criteria

  • Taken prednisone or cortisone medications in the previous 30 days
  • Currently pregnant or planning pregnancy during the study period
  • Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
  • Unable to follow the study protocol
  • Unable to speak, read and write in English

Treatment and study plan

SMBG to guide clinical decisions

Other

The investigator will base clinical decisions on A1c and modal day analysis of SMBG.

SMBG and CGM

Other

The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.

Primary outcomes

  1. Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes.

    Time frame: Three, six and nine months.

Secondary outcomes

  1. Determine the incremental benefit of CGM for clinical decision-making.

    Time frame: Three, six and nine months.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Abbott Diabetes Care
  • International Diabetes Center at Park Nicollet

Registry information

Official study title

Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 22, 2010
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.