Clinical trial NCT00569907: Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide
Official title: Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2
Keywords: type 2 diabetes
continuous glucose monitoring
exenatide
exenatide use
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2007-12-10
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center - Park Nicollet Health Services
state: Minnesota
Study officials:
affiliation: International Diabetes Center - Park Nicollet Institute
name: Roger Mazze, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center - Park Nicollet Institute
name: Robert M. Cuddihy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center - Park Nicollet Institute
name: Ellie Strock, ANP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazze RS, Lucido D, Langer O, Hartmann K, Rodbard D. Ambulatory glucose profile: representation of verified self-monitored blood glucose data. Diabetes Care. 1987 Jan-Feb;10(1):111-7. doi: 10.2337/diacare.10.1.111.
citation: Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD; Exenatide-113 Clinical Study Group. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004 Nov;27(11):2628-35. doi: 10.2337/diacare.27.11.2628.
citation: DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005 May;28(5):1092-100. doi: 10.2337/diacare.28.5.1092.
citation: Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006 Jan;29(1):44-50. doi: 10.2337/diacare.29.01.06.dc05-1686.