Examining The Role of CGM in T2DM

Completed · Not applicable

Conditions studied: DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)

In brief

Continuous glucose monitoring (CGM) technology has advanced the treatment of people with diabetes, however to date this technology had been primarily limited to use in patients treated with insulin. CGM is a powerful tool that has the potential to enhance the care of patients treated with agents other than insulin; however this has not been tested. The purpose of this study is to determine whether improved glycemic control can be achieved through the use of intensive, periodic CGM monitoring in patients with T2DM treated with oral anti-hyperglycemic drugs (OADs). The data gathered from this pilot study will be utilized to determine if a larger, clinical effectiveness study to assess use of CGM to improve clinical outcomes in patients with T2DM treated with OADs is warranted.

Key facts

Study ID

NCT01614262

Run by

University of North Carolina, Chapel Hill

People needed

35

Starts

2012-06-01

Expected to finish

2014-09-01

Last updated by the study team

2017-04-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A subject is eligible for the study if all of the following criteria are met:
• Provide written informed consent prior to enrollment
• Is male or female between 18-70 years old
• Has been treated by the Principal Investigator or referring physician in the same practice.
• Has Type 2 Diabetes Mellitus for greater than 12 months on 1-3 antihyperglycemic medications, on a stable dose for 90 days prior to screening.
• Has a HbA1c between 7.5-9.0% in the 90 days prior to screening.
• Currently performs self-monitoring blood glucose checks at least 3 times per week.
• Ability to adhere to protocol requirements.

You may not qualify if…

• 1. Has Type 1 Diabetes or Gestational Diabetes
• Is pregnant or planning to become pregnant during the course of the study.
• Current use of any insulin or history of insulin use in the last 6 months.
• An acute coronary or cerebrovascular event in the previous 3 months.
• Any planned surgery during the course of the study.
• Current continuous renal replacement therapy.
• BMI ≥ 45 kg/m\^2
• Current oral or injectable steroid use.
• Any previous history Continuous Glucose Monitoring use by any device or manufacturer.
• Has a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Where it is running

• Atlanta Diabetes Assoicates — Atlanta, Georgia, United States
• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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