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Completed

NCT Number: NCT00818077

Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

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 continuously. Breakfast and lunch meals will be provided and must be consumed at the International Diabetes Center.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

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

  • 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 criteria

  • 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

Treatment and study plan

Continuous Glucose Monitoring of Carbohydrate Intake

Other

Subjects eat standard breakfast and lunch and keep food records.

Other names: Navigator CGM System

Primary outcomes

  1. Glycemic Response to the Fixed Meal

    Time frame: 4 hour meal test

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Abbott Diabetes Care
  • International Diabetes Center at Park Nicollet

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Jan 7, 2009
Registry last updated
Dec 2, 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.

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