Examining The Role of CGM in T2DM

NCT01614262 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-04-19

No results posted yet for this study

Summary

Continuous glucose monitoring (CGM) technology has advanced the treatment of people with diabetes, however to date this technology had been primarily limited to use in patients treated with insulin. CGM is a powerful tool that has the potential to enhance the care of patients treated with agents other than insulin; however this has not been tested. The purpose of this study is to determine whether improved glycemic control can be achieved through the use of intensive, periodic CGM monitoring in patients with T2DM treated with oral anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be utilized to determine if a larger, clinical effectiveness study to assess use of CGM to improve clinical outcomes in patients with T2DM treated with OADs is warranted.

Conditions

  • DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)

Interventions

OTHER

Continuous Glucose Monitoring with treatment algorithm

those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY
  • Atlanta Diabetes Associates

    collaborator OTHER
  • UNC Coordinating Center

    collaborator UNKNOWN
  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • John B Buse, MD, PhD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01614262 on ClinicalTrials.gov