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
  Purpose

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 Park Nicollet Institute:

Primary Outcome Measures:
  • Glycemic Response to the Fixed Meal [ Time Frame: 4 hour meal test ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818077

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

Publications:
Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT00818077     History of Changes
Other Study ID Numbers: 03654-07-A
Study First Received: January 5, 2009
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014