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

NCT00569907 | Completed

• 1 other identifier: 03520-06-C
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Keywords

type 2 diabetes; continuous glucose monitoring; exenatide; exenatide use

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

International Diabetes Center - Park Nicollet Health Services

Minneapolis, Minnesota, 55416, United States

Location

Related Publications (4)

• 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.

  PMID: 3552508 BACKGROUND

• 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.

  PMID: 15504997 BACKGROUND

• 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.

  PMID: 15855572 BACKGROUND

• 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.

  PMID: 16373894 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 10, 2007
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: November 26, 2015

Record last verified: 2010-08

Locations

US (1)