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Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

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ClinicalTrials.gov Identifier: NCT00818077
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : December 2, 2015
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Abbott Diabetes Care
Information provided by (Responsible Party):
HealthPartners Institute

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

Condition or disease Intervention/treatment
Type 2 Diabetes Currently Taking Metformin Other: Continuous Glucose Monitoring of Carbohydrate Intake

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food
Study Start Date : January 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Group/Cohort Intervention/treatment
Metformin, Type 2 Diabetes Other: Continuous Glucose Monitoring of Carbohydrate Intake
Subjects eat standard breakfast and lunch and keep food records.
Other Name: Navigator CGM System



Primary Outcome Measures :
  1. Glycemic Response to the Fixed Meal [ Time Frame: 4 hour meal test ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
type 2 diabetes, 18 years of age of older, currently taking metformin
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818077


Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
International Diabetes Center at Park Nicollet
Abbott Diabetes Care
Investigators
Principal Investigator: Margaret Powers, PhD, RD, CDE International Diabetes Center at Park Nicollet