Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

Completed

• Conditions: Currently Taking Metformin; Type 2 Diabetes
• Interventions: Other: Continuous Glucose Monitoring of Carbohydrate Intake

• Registration Number: NCT00818077
• Lead Sponsor: HealthPartners Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-07
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Study Completion: 2010-09
• Status Verified: 2013-08
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metformin, Type 2 Diabetes	Continuous Glucose Monitoring of Carbohydrate Intake	-

Primary Outcome Measures

Name	Time	Method
Glycemic Response to the Fixed Meal	4 hour meal test

Trial Locations

Locations (1)

International Diabetes Center; 🇺🇸 Minneapolis, Minnesota, United States