Status:

COMPLETED

Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes

Lead Sponsor:

HealthPartners Institute

Collaborating Sponsors:

Roche Diagnostics GmbH

International Diabetes Center at Park Nicollet

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions related to the management of type 2 diabetes. The secondary objective is to determine the benefit of using CGM f...

Detailed Description

This study involves the use of the following 2 glucose monitoring methods to measure your blood sugar (glucose) levels and help manage type 2 diabetes: 1. Self Monitoring Blood Glucose (SMBG): blood ...

Eligibility Criteria

Inclusion

  • Male or female ≥18 and ≤75 years of age (Upper range to assure dexterity for use of CGM)
  • Clinical diagnosis of type 2 diabetes
  • HbA1c ≥7.0%
  • Diabetes can be treated with any of the following therapies within one month prior to study enrollment: (1) medical nutrition therapy alone or with metformin; (2) sulfonylurea with or without metformin; (3) dipeptidyl peptidase 4 (DPP-4) inhibitor or Glucagon-like peptide-1 (GLP-1) agonist with or without metformin; or insulin with or without metformin.

Exclusion

  • Treated with Thiazolidinediones (TZD)
  • Administered 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
  • HbA1c \<7.0%
  • Unable to follow the study protocol
  • Unable to speak, read and write in English

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2012

Estimated Enrollment :

124 Patients enrolled

Trial Details

Trial ID

NCT01237301

Start Date

October 1 2010

End Date

March 1 2012

Last Update

October 17 2018

Active Locations (1)

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1

International Diabetes Center

Minneapolis, Minnesota, United States, 55416