Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide

HealthPartners Institute

Status: Completed

Conditions: Diabetes Mellitus Type 2

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00569907

03520-06-C

Details and patient eligibility

About

Approximately 30 adults will participate in this study at the International Diabetes Center (IDC). The IDC is the only site conducting this study.

Length of participation can range from two to three months which will include four to seven clinic visits.

The purpose of this study is to use a Continuous Glucose Monitoring (CGM) system to determine the characteristics of glucose control and patterns of food intake before exenatide is started, during the start and adjustment of exenatide and during exenatide treatment.

The long-term purpose of this study is to determine to what extent continuous glucose monitoring improves or alters clinical decision making for patients treated with exenatide. And, the study will also compare CGM to conventional self-monitored blood glucose methods.

The study will also compare subjects' changes, if any, in nutrient intake such as energy, protein, fat and carbohydrate during the course of the study through interpretation/analysis of self-reported food intake.

Enrollment: 18 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female (if of child-bearing age must practice appropriate birth control such as tubal ligation, oral contraceptives, abstinence or vasectomized partner during the duration of the study)
• Previously diagnosed with type 2 diabetes
• Age 21 and older
• Treated with metformin, a sulfonylurea, a thiazolidinedione, a combination or metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione (approved FDA indications)
• HbA1c 7.1-11%, unless subject has been using exenatide prior to study; in that case, there is no restriction on HbA1c level.
• Willing to give informed consent
• 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 21 years of age
• Pregnancy
• Creatinine clearance <30 ml/min (using MDRD formula)
• Known gastrointestinal disease
• Without diabetes or known type 1 diabetes
• Unable to follow the study protocol
• Unable to read and write in English
• Allergy to adhesives
• Any concomitant medical condition that would likely affect the evaluation of CGM device performance as determined by the investigator such as dermatological conditions or myxedema.