Clinical trial NCT00818077: Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food
Official title: Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Currently Taking Metformin
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: Abbott Diabetes Care
First posted: 2009-01-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 diabetes, 18 years of age of older, currently taking metformin

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Glycemic Response to the Fixed Meal
timeFrame: 4 hour meal test
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Margaret Powers, PhD, RD, CDE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.