Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00818077

Enrollment

Registered

2009-01-07

Start date

2008-01-31

Completion date

2010-09-30

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Currently Taking Metformin, Type 2 Diabetes

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.

Interventions

OTHERContinuous Glucose Monitoring of Carbohydrate Intake

Subjects eat standard breakfast and lunch and keep food records.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Glycemic Response to the Fixed Meal	4 hour meal test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026