Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Abbott Diabetes Care
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00818077
First received: January 5, 2009
Last updated: August 22, 2013
Last verified: August 2013

January 5, 2009
August 22, 2013
January 2008
July 2008   (final data collection date for primary outcome measure)
Glycemic Response to the Fixed Meal [ Time Frame: 4 hour meal test ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00818077 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

type 2 diabetes, 18 years of age of older, currently taking metformin

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2010
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00818077
03654-07-A
No
Park Nicollet Institute
Park Nicollet Institute
  • International Diabetes Center at Park Nicollet
  • Abbott Diabetes Care
Principal Investigator: Margaret Powers, PhD, RD, CDE International Diabetes Center at Park Nicollet
Park Nicollet Institute
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP