Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food - Full Text View

Sponsors and Collaborators:	Park Nicollet Institute International Diabetes Center Abbott Diabetes Care
Information provided by:	Park Nicollet Institute
ClinicalTrials.gov Identifier:	NCT00818077

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

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

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

Further study details as provided by Park Nicollet Institute:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	15
Study Start Date:	January 2008
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.

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

Abbott Diabetes Care

Investigators

Principal Investigator:

Margaret Powers, PhD, RD, CDE

International Diabetes Center

More Information

Publications:

American Diabetes Association. Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007 Jan;30 Suppl 1:S48-65. No abstract available.

Franz MJ, Boucher JL, Green-Pastors J, Powers MA. Evidence-based nutrition practice guidelines for diabetes and scope and standards of practice. J Am Diet Assoc. 2008 Apr;108(4 Suppl 1):S52-8. Review.

Crapo PA, Reaven G, Olefsky J. Postprandial plasma-glucose and -insulin responses to different complex carbohydrates. Diabetes. 1977 Dec;26(12):1178-83.

Responsible Party:	International Diabetes Center ( Margaret Powers, PhD, RD, CDE )
Study ID Numbers:	03654-07-A
Study First Received:	January 5, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00818077
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009