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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00569907
First received: December 6, 2007
Last updated: August 16, 2010
Last verified: August 2010
  Purpose

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.


Condition
Diabetes Mellitus Type 2

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Enrollment: 18
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569907

Locations
United States, Minnesota
International Diabetes Center - Park Nicollet Health Services
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
Eli Lilly and Company
Investigators
Principal Investigator: Roger Mazze, PhD International Diabetes Center - Park Nicollet Institute
Principal Investigator: Robert M. Cuddihy, MD International Diabetes Center - Park Nicollet Institute
Principal Investigator: Ellie Strock, ANP International Diabetes Center - Park Nicollet Institute
  More Information

Publications:
Responsible Party: Roger S. Mazze, PhD - Chief Academic Officer, Park Nicollet Institute dba International Diabetes Center
ClinicalTrials.gov Identifier: NCT00569907     History of Changes
Other Study ID Numbers: 03520-06-C
Study First Received: December 6, 2007
Last Updated: August 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
type 2 diabetes
continuous glucose monitoring
exenatide
exenatide use

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014