Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

HealthPartners Institute

Status: Completed

Conditions: Type 2 Diabetes; Currently Taking Metformin

Treatments: Other: Continuous Glucose Monitoring of Carbohydrate Intake

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00818077

03654-07-A

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Metformin, Type 2 Diabetes

Treatment:

Other: Continuous Glucose Monitoring of Carbohydrate Intake