Status:

COMPLETED

Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

Lead Sponsor:

HealthPartners Institute

Collaborating Sponsors:

International Diabetes Center at Park Nicollet

Abbott Diabetes Care

Conditions:

Type 2 Diabetes

Currently Taking Metformin

Eligibility:

All Genders

18+ years

Brief Summary

This study will look at the impact that meals have on blood glucose (sugar) levels. Subjects will be asked to use a Continuous Glucose Monitoring System (CGM), which monitors glucose levels continuous...

Eligibility Criteria

Inclusion

  • Female or male
  • Age 18 and older
  • Diagnosed with type 2 diabetes for a minimum of 6 months
  • Is taking metformin for diabetes management; no other diabetes medications
  • Has been on a stable dose of metformin for at least 3 months
  • HbA1c is 7% or greater and less than 9%; \>7% or \<9%
  • BMI \<30kg/m2
  • Willing to give informed consent
  • No evidence of acute illness, fever, undue stress
  • Motivated and capable of following the protocol and instructions provided by the healthcare professional
  • Available for the study on the scheduled visit days
  • Access to telephone communications

Exclusion

  • Under 18 years of age
  • Has not been diagnosed with type 2 diabetes for a minimum of 6 months
  • Is currently taking other diabetes medications in addition to metformin
  • Has taken other diabetes medications within the past 3 months
  • HbA1c \<7% or \>9%
  • BMI \> 30kg/m2
  • Unable to follow the study protocol
  • No access to telephone communications
  • Unable to read and write in English
  • Unable to maintain their health, or have undue stress
  • Skin abnormalities at the insertion sites that would confound assessment of the effect of the device on the skin
  • Allergy to adhesives
  • Any concomitant medical condition that would likely affect the evaluation of device performance
  • Taken oral or inhaled prednisone or cortisone medications in the previous 30 days

Key Trial Info

Start Date :

January 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT00818077

Start Date

January 1 2008

End Date

September 1 2010

Last Update

December 2 2015

Active Locations (1)

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International Diabetes Center

Minneapolis, Minnesota, United States, 55416