Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2007 |
| End Date: | May 2009 |
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.
(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.
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.
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