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Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

This study has been completed.
International Diabetes Center at Park Nicollet
Abbott Diabetes Care
Information provided by (Responsible Party):
HealthPartners Institute Identifier:
First received: January 5, 2009
Last updated: November 30, 2015
Last verified: August 2013
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 Intervention
Type 2 Diabetes
Currently Taking Metformin
Other: Continuous Glucose Monitoring of Carbohydrate Intake

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

Resource links provided by NLM:

Further study details as provided by HealthPartners Institute:

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

Enrollment: 15
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00818077

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
Principal Investigator: Margaret Powers, PhD, RD, CDE International Diabetes Center at Park Nicollet