- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818077
Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food
November 30, 2015 updated by: HealthPartners Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55416
- International Diabetes Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
type 2 diabetes, 18 years of age of older, currently taking metformin
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Metformin, Type 2 Diabetes
|
Subjects eat standard breakfast and lunch and keep food records.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycemic Response to the Fixed Meal
Time Frame: 4 hour meal test
|
4 hour meal test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Margaret Powers, PhD, RD, CDE, International Diabetes Center at Park Nicollet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.2337/dc07-S048. 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. doi: 10.1016/j.jada.2008.01.021.
- Crapo PA, Reaven G, Olefsky J. Postprandial plasma-glucose and -insulin responses to different complex carbohydrates. Diabetes. 1977 Dec;26(12):1178-83. doi: 10.2337/diab.26.12.1178.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 6, 2009
First Posted (Estimate)
January 7, 2009
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
August 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 03654-07-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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