Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

Type 2 Diabetes Clinical Trial

Official title:

Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818077
• Other study ID #: 03654-07-A
• Status: Completed
• Phase: N/A
• First received: January 5, 2009
• Last updated: November 30, 2015
• Start date: January 2008
• Est. completion date: September 2010

Study information

• Verified date: August 2013
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Currently Taking Metformin
• Type 2 Diabetes

Intervention

Other:
• Continuous Glucose Monitoring of Carbohydrate Intake
Subjects eat standard breakfast and lunch and keep food records.

Locations

Country	Name	City	State
United States	International Diabetes Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	Abbott Diabetes Care, International Diabetes Center at Park Nicollet

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Response to the Fixed Meal		4 hour meal test	No